Management of Overweight and Obese
Adults
Guideline Panel Members
Saudi Expert Panel
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*Dr Assim A. Alfadda
*Ms Madawi M. Al-Dhwayan
Dr Abdulhameed Alharbi
Dr Basma Alkhudhair
Dr Omar M. Al Nozha
Dr Nawal Al-Qahtani
Dr Saad A. Alzahrani
Dr Wedad Bardisi
*Dr Reem M. Sallam
*Obesity Research Center, College of Medicine, King Saud University
McMaster University Working Group
Ainsley Moore, MD MSc, John Riva, BA DC MSc, Jan L Brożek, MD PhD, and Holger J Schünemann, MD PhD, on behalf of the McMaster Guideline Working Group
Acknowledgements
We acknowledge Dr. Mohammed Y. Al-Naami for his contribution to this work.
We gratefully acknowledge Dr. Rajaa Al-Raddadi from the Ministry of Health for
peer reviewing this final report.
Disclosure of potential conflict of interest:
All authors declare that they have no conflict of interest related to this guideline.
Funding:
This clinical practice guideline was funded by the Ministry of Health, Saudi Arabia.
Address for correspondence:
Saudi Center for Evidence Based Health Care
E-mail: [email protected]
Web: http://www.moh.gov.sa/endepts/Proofs/Pages/home.aspx
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Management of Overweight and Obese
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Contents
The Saudi Center for Evidence Based Health Care (EBHC) .................................................................... iv
Executive Summary................................................................................................................................. 1
Introduction ........................................................................................................................................ 1
Methodology....................................................................................................................................... 1
How to use these guidelines ............................................................................................................... 1
Key questions ...................................................................................................................................... 2
Recommendations .............................................................................................................................. 3
Scope and purpose.................................................................................................................................. 5
Introduction ............................................................................................................................................ 5
Methodology........................................................................................................................................... 5
How to use these guidelines ................................................................................................................... 6
Key questions .......................................................................................................................................... 7
Recommendations .................................................................................................................................. 7
Question 1: Should psychotherapy-cognitive behavioural therapy (CBT) compared to no cognitive
behavioural therapy be used for overweight and obese adults? ....................................................... 8
Question 2: Should intensive lifestyle interventions compared to usual care be used for
overweight and obese adults? ............................................................................................................ 9
Question 3: Should lifestyle interventions compared to other interventions be used for overweight
and obese adults? ............................................................................................................................. 10
Question 4: Should nutrition and physical activity counselling compared to health education
pamphlets be used for overweight and obese adults?..................................................................... 11
Question 5: Should iso-caloric low-fat compared to moderate-fat diet be used for overweight and
obese adults? .................................................................................................................................... 12
Questions 6 & 7: Should physical activity and diet compared to diet or physical activity alone be
used for overweight and obese adults?............................................................................................ 14
Question 8: Should portion-controlled diet compared to non-portion controlled diet be used for
obese and overweight adults? .......................................................................................................... 16
Question 9: Should metformin compared to no metformin be used for overweight and obese
adults? ............................................................................................................................................... 17
Question 10: Should orlistat compared to no orlistat be used for overweight and obese adults? . 18
Question 11: Should bariatric surgery compared to non-surgical therapies be used for overweight
and obese adults? ............................................................................................................................. 19
References ............................................................................................................................................ 22
Appendices............................................................................................................................................ 25
Appendix 1: Evidence to Decision Frameworks ................................................................................ 26
Guideline Question 1: Should psychotherapy (CBT) compared to no psychotherapy be used for
overweight and obese adults? ...................................................................................................... 26
Guideline Question 2: Should intensive lifestyle intervention (diet, exercise and behaviour
modification) compared to usual, minimal care be used for overweight and obese adults? ...... 33
Guideline Question 3: Should lifestyle interventions compared to usual care be used for
overweight and obese adults? ...................................................................................................... 41
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Guideline Question 4: Should nutrition and physical activity counselling compared to health
education pamphlets be used for overweight and obese adults? ............................................... 50
Guideline Question 5: Should isocaloric low fat diet compared to moderate fat diet be used for
overweight and obese adults? ...................................................................................................... 58
Guideline Question 6: Should physical activity compared to no physical activity be used in obese
and overweight adults? ................................................................................................................ 69
Guideline Question 7: Should diet and physical activity compared to diet alone be used for
obese and overweight adults? ...................................................................................................... 77
Guideline Question 8: Should portion-controlled diet compared to non-portion controlled diet
be used for obese and overweight adults? ................................................................................... 88
Guideline Question 9: Should metformin compared to no metformin be used for overweight
and obese adults? ......................................................................................................................... 95
Guideline Question 10: Should orlistat compared to no orlistat be used for overweight and
obese adults? .............................................................................................................................. 104
Guideline Question 11: Should bariatric surgery compared to non-surgical therapies be used for
overweight and obese adults? .................................................................................................... 114
Appendix 2: Search Strategies and Results ..................................................................................... 121
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The Saudi Center for Evidence Based Health Care (EBHC)
The Saudi Centre for Evidence Based Health Care has managed and supported the coordination of
the process of clinical practice guideline (CPG) development between the methodological team from
McMaster University and the local clinical expert panel members in Saudi Arabia.
The EBHC staff members recruited local clinical experts through contacting Saudi specialist societies
and also independent experts interested in developing reliable and most up-to-date CPGs to harmonize the treatment and provide the highest quality of health care in the kingdom of Saudi Arabia.
These experts were health care professionals of multidisciplinary backgrounds. As much as possible,
patient’s representatives were also included in panels.
In an effort to make national recommendations, the participating experts were professionals from
the Ministry of Health (MoH), King Saud University, National Guard Hospitals, King Faisal Specialist
Hospital and Research Centre (KFSHRC), University Hospitals, Security Forces Hospitals, Prince Sultan
Military Medical City (PSMMC) and from some private hospitals.
Based on a preselection of available evidence syntheses, the EBHC provided a list of potential topics
to be addressed in CPGs after thorough consultations with the local stakeholders. These topics were
further discussed with the McMaster team for important selection criteria and agreed on 12 topics
for wave 2.
The guideline panel meetings were held in Riyadh on 15th-18th March 2015 where about 96 local experts working in Saudi Arabia participated with the methodological support from 20 experts from
McMaster University and its partners from the American University of Beirut, Lebanon, and the University of Freiburg, Germany, in providing high quality recommendations for common and important
clinical conditions in the Kingdom.
The Saudi Centre for EBHC supports the efforts for dissemination of the CPGs by publishing online
the full reports of the CPGs, facilitates writing concise versions of the CPGs for publication in peer
reviewed medical journals, and sending hard copies to hospitals and health care centers. Finally, a
mobile App has been introduced in KSA to facilitate the dissemination efforts of the completed practice guidelines.
The staff members at the Saudi Centre for EBHC:
Dr Zulfa Al Rayess, Consultant Family Medicine, Head of Saudi Center for EBHC
Dr Yaser Adi, Scientific Advisor for the Saudi Centre for EBHC
Miss Nourah Al Moufarreh, Project Manager, Saudi Center for EBHC
Management of Overweight and Obese
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Executive Summary
Introduction
Obesity in Saudi Arabia is a growing health
concern. Obese and overweight adults represent over 70% of the population.1 Females are
significantly more obese than males with a
prevalence of 44%, compared to 26%, while
overweight is significantly more prevalent
among males (42.4%) compared to females
(31.8%). 1 Obesity and overweight are well
known risk factors for diabetes, coronary artery disease, hypertension, breathing and
sleep disorders, as well as impaired quality of
life. Such co-morbidities as well as determinants of obesity are multifactorial requiring
multiple approaches to population management in various settings with input from a
range of stakeholders. This guideline therefore considers the diversity of pharmacological, non-pharmacological-lifestyle, as well as
surgical management strategies from a range
of expert perspectives in order to derive relevant recommendations. Reduction in obesity
is an important public health consideration for
the Kingdom of Saudi Arabia. The recommendations from this report contribute to the current development of a national strategy to
combat obesity. 2
Given the importance of this topic, the Ministry of Health of the Kingdom of Saudi Arabia
with the support of the McMaster University
working group produced practice guidelines
to assist health care providers in evidencebased decision-making on the management of
overweight and obese adults.
1
The Saudi expert guideline panel selected the
topic of this guideline and all healthcare questions addressed herein using a formal prioritization process. For all selected questions we
updated an existing systematic review on the
management of obesity for adults from 2013,
published by the National Health and Medical
Research Council, Australia. 13 For selected
questions we updated existing systematic reviews
on
pharmacological,
nonpharmacological and surgical approaches to
management of obesity in adults. We also
conducted systematic searches for information that was required to develop full
guidelines for the KSA, including searches for
information about patients’ values and preferences, and costs and resource use specific
to the Saudi context. Based on the systematic
reviews we prepared summaries of available
evidence supporting each recommendation
following the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach. 3,7 We used this information
to prepare GRADE evidence-to-decision
frameworks that served the guideline panel to
follow the structured consensus process and
transparently document all decisions made
during the meeting (see Appendix 1). The
guideline panel met in Riyadh on March 17th
and 18th, 2015 and formulated all recommendations during this meeting. Potential conflicts of interests of all panel members were
managed according to the World Health Organization (WHO) rules.4
As a quality measure prior to publication, the
final report has been externally peer reviewed
by a methodological expert who has not been
involved in this guideline development.
Methodology
How to use these guidelines
This practice guideline is a part of the larger
initiative of the Ministry of Health of the Kingdom of Saudi Arabia (KSA) to establish a program of rigorous development of guidelines.
The ultimate goals are to provide guidance for
clinicians and other healthcare decision makers and reduce unnecessary variability in clinical practice across the Kingdom.
The guideline working group developed and
graded the recommendations and assessed
the quality of the supporting evidence according to the GRADE approach. 3,5 Quality of evidence (confidence in the estimates of effects)
is categorized as: high, moderate, low, or very
low based on consideration of risk of bias,
Management of Overweight and Obese
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indirectness, inconsistency, imprecision and
publication bias of the estimates as well as
factors that lead to upgrading the quality of
the evidence. High quality evidence indicates
that we are very confident that the true effect
lies close to that of the estimate of the effect.
Moderate quality evidence indicates moderate confidence, and that the true effect is likely close to the estimate of the effect, but
there is a possibility that it is substantially different. Low quality evidence indicates that
our confidence in the effect estimate is limited, and that the true effect may be substantially different. Finally, very low quality evi-
2
dence indicates that the estimate of effect of
interventions is very uncertain, the true effect
is likely to be substantially different from the
effect estimate and further research is likely
to have important potential for reducing the
uncertainty.
The strength of recommendations is expressed as either strong (‘guideline panel recommends…’) or conditional (‘guideline panel
suggests…’) and has explicit implications (see
Table 1).6 Understanding the interpretation of
these two grades is essential for sagacious
clinical decision-making.
Table 1: Interpretation of strong and conditional (weak) recommendations
Implications
For patients
For clinicians
For policy makers
Strong recommendation
Most individuals in this situation
would want the recommended
course of action and only a small
proportion would not. Formal decision aids are not likely to be needed
to help individuals make decisions
consistent with their values and preferences.
Most individuals should receive the
intervention. Adherence to this recommendation according to the
guideline could be used as a quality
criterion or performance indicator.
Conditional (weak) recommendation
The majority of individuals in this situation would want the suggested course
of action, but many would not.
Recognize that different choices will be
appropriate for individual patients and
that you must help each patient arrive
at a management decision consistent
with his or her values and preferences.
Decision aids may be useful helping
individuals making decisions consistent
with their values and preferences.
The recommendation can be adapted Policy making will require substantial
as policy in most situations
debate and involvement of various
stakeholders.
Key questions
The following is a list of the clinical questions
selected by the Saudi expert panel and addressed in this guideline.
I. Non-pharmacological Management
1. Should psychotherapy (cognitive behavioural therapy) compared to no
psychotherapy be used for overweight and obese adults?
2. Should intensive lifestyle interventions compared to usual care be used
for overweight and obese adults?
3. Should lifestyle interventions compared to usual care be used for overweight and obese adults?
4. Should nutrition and physical activity
counselling compared to general
health information pamphlets be used
for overweight and obese adults?
Management of Overweight and Obese
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5. Should isocaloric low fat compared to
moderate fat diet be used for overweight and obese adults?
6. Should exercise compared to no exercise be used in obese and overweight
adults?
7. Should diet and exercise compared to
diet alone be used for overweight and
obese adults?
8. Should portion-controlled diets be
used for overweight and obese
adults?
3
Recommendation 2:
The panel suggests using intensive lifestyle
modification rather than usual or minimal
care in overweight and obese adults. (conditional recommendation, moderate quality
evidence)
Remarks:
 This recommendation pertains to
those who are at higher risk for obesity-related co-morbidities such as
diabetes as they would benefit more
from intensive lifestyle interventions.
II. Pharmacological Management
9. Should Metformin compared to no
Metformin be used in overweight and
obese adults?
10. Should Orlistat compared to no
Orlistat be used for overweight and
obese adults?
III. Surgical Management
11. Should bariatric surgery be used for
overweight and obese adults?
Recommendation 3:
The panel recommends lifestyle intervention
rather than usual care alone in overweight
and obese adults. (strong recommendation,
moderate quality evidence)
Recommendation 4:
The panel recommends individualized counselling interventions rather than generic educational pamphlets in overweight or obese
adults. (strong recommendation, low quality
evidence)
Recommendations
I. Non-pharmacological Management
Recommendation 1:
The panel suggests cognitive behavioral therapy (CBT) rather than no such therapy in
overweight and obese adults. (conditional
recommendation, low quality evidence)
Remarks:
 This recommendation pertains to
general obese populations. Individuals
with suspected or confirmed eating
disorders or depression require specialized psychiatric assessment and
management.
Recommendation 5:
The panel makes no clinical recommendation
regarding iso-caloric low-fat versus moderatefat diets. The panel suggests randomized controlled trials be done with adequate follow-up
duration that compare iso-caloric diets with
fat content lower than 20%, approximately
20% and approximately 30%. (low quality evidence)
Remarks:
Panel members judged that there was not
enough evidence to choose one option over
another. If any diet is used, fat content should
be determined according to AMDR and fat
subtypes should be defined (saturated fatty
acids, trans fatty acids, Omega 3 and 6 fatty
acids) in order to evaluate benefits or harms
Management of Overweight and Obese
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Recommendation 6 & 7:
The panel recommends physical activity rather than no physical activity in overweight
and obese adults. (strong recommendation,
low quality evidence)
The panel recommends physical activity in
addition to diet rather than diet alone in
overweight or obese adults. (strong recommendation, very low quality evidence)
Recommendation 8:
The panel does not make a clinical recommendation on portion-controlled diets. The
panel suggests that more research be done.
(very low quality evidence)
II. Pharmacological Management
Recommendation 9:
The panel suggests metformin in obese or
overweight adults. (conditional recommendation, low quality evidence)
Recommendation 10:
The panel suggests orlistat in obese and
overweight adults. (conditional recommendation, moderate quality evidence)
III. Surgical Management
Recommendation 11:
The panel suggests using bariatric surgery in
obese adults (BMI ≥40 or ≥35 kg/m2 with
comorbidities). (conditional recommendation,
moderate quality evidence)
Remarks:
 This recommendation pertains to individuals with larger BMI since anticipated benefits are larger in individuals
who are at higher health risk due to
obesity when considering risks associated with surgery. It also considers
implementation requirements of interdisciplinary teams to prevent and
manage lifelong dietary deficiencies
and complications.
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Management of Overweight and Obese
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Scope and purpose
The purpose of this document is to provide
guidance about the management of overweight and obese adults. The target audience
of these guidelines includes; general practitioners, family physicians, allied health professionals and specialists concerned with the
management of overweight and obese adults
in the Kingdom of Saudi Arabia (KSA). Other
health care professionals and policy makers
may also benefit from these guidelines.
Given the importance of this topic, the Ministry of Health (MoH) of Saudi Arabia with the
support of the McMaster University working
group produced practice guidelines to assist
health care providers in evidence-based decision-making. This practice guideline is a part
of the larger initiative of the Ministry of
Health of Saudi Arabia to establish a program
of rigorous adaptation and de novo development of guidelines in the Kingdom; the ultimate goal being to provide guidance for clinicians and other healthcare decision makers
and reduce unnecessary variability in clinical
practice across the Kingdom.
Introduction
Obesity in Saudi Arabia is a growing health
concern where obese and overweight adults
represent over 70% of the population. 1 Females are significantly more obese than males
with a prevalence of 44%, compared to 26%,
while overweight is significantly more prevalent among males (42.4%) compared to 31.8%
of females. 1 Obesity and overweight are well
known risk factors for diabetes, coronary artery disease, hypertension, breathing and
sleep disorders, as well as impaired quality of
life. Such co-morbidities as well as determinants of obesity are multifactorial, requiring
multiple approaches to population management in various settings with input from a
range of stakeholders.
Reduction in obesity is an important public
health consideration for the Kingdom and this
5
guideline considers the diversity of pharmacological, non-pharmacological-lifestyle, as well
as surgical management strategies that contribute to the current development of a broad
national strategy to combat obesity. 2
Non-pharmacological recommendations from
this guideline consider lifestyle and intensive
lifestyle interventions which include; psychotherapy, nutrition and exercise strategies.
Psychotherapy is considered in the context of
cognitive behavioural therapy, the predominant approach to change-therapy in chronic
disease management. Nutrition strategies are
considered in the context of low fat and portion-controlled diets. Exercise strategies are
considered in the context of diet and exercise
in combination, as well as exercise alone.
Pharmacological recommendations consider
both Metformin and Orlistat. Lastly, bariatric
surgery is considered broadly for those with
BMI ≥40 Kg/m2, or ≥35 Kg/m2 with comorbidities.
Methodology
To facilitate the interpretation of these guidelines; we briefly describe the methodology we
used to develop and grade recommendations
and quality of the supporting evidence.
The Saudi expert guideline panel selected the
topic of this guideline and all healthcare questions addressed herein using a formal prioritization process. For all selected questions we
updated an existing systematic review on the
management of obesity for adults from 2013,
published by the National Health and Medical
Research Council, Australia 13 For selected
questions we updated existing systematic reviews
on
pharmacological,
nonpharmacological and surgical approaches to
management of obesity in adults. For each
question, the McMaster guideline working
group updated the search strategy to identify
new studies and/or new systematic reviews.
When relevant, the meta-analyses were updated. We also conducted systematic searches for information that was required to devel-
Management of Overweight and Obese
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op full guidelines for the KSA, including
searches for information about patients’ values and preferences, and costs and resource
use specific to the Saudi context
(see Appendix 2).
Next, we developed for each question an evidence profile and an evidence-to-decision
(EtD) table following the GRADE (Grading of
Recommendations, Assessment, Development
and Evaluation) approach and shared them
with the panel members (see Appendix 1). 3,7
The guideline panel was invited to provide
additional information, particularly when published evidence was lacking. The final step
consisted of an in-person meeting of the
guideline panel in Riyadh on March 17th and
18th 2015 to formulate the final recommendations. We used the GRADE evidence-todecision frameworks to follow a structured
consensus process and transparently document all decisions made during the meeting.
Potential conflicts of interests of all panel
members were managed according to the
World Health Organization (WHO) rules.3
Grading of the quality of evidence
The GRADE working group defines the quality
of evidence as the extent of our confidence
that the estimate of an effect is adequate to
support a particular decision or recommendation.3 We assessed the quality of evidence
using the GRADE approach.
Quality of evidence is classified as “high”,
“moderate”, “low”, or “very low” based on
decisions about methodological characteristics of the available evidence for a specific
health care problem. The definition of each
category is as follows:
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

High: We are very confident that the
true effect lies close to that of the estimate of the effect.
Moderate: We are moderately confident in the effect estimate: The true
effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low: Our confidence in the effect estimate is limited: The true effect may
6

be substantially different from the estimate of the effect.
Very low: We have very little confidence in the effect estimate: The true
effect is likely to be substantially different from the estimate of effect.
Grading of the strength of recommendations
The GRADE working group defines the
strength of recommendation as the extent to
which we can be confident that desirable effects of an intervention outweigh undesirable
effects. According to the GRADE approach,
the strength of a recommendation is either
strong or conditional (also known as or called
weak) and has explicit implications.6 Understanding the interpretation of these two
grades – either strong or conditional – of the
strength of recommendations is essential for
sagacious clinical decision-making.
(see Table 1)
As a quality measure prior to publication, the
final report has been externally peer reviewed
by a methodological expert who has not been
involved in this guideline development.
How to use these guidelines
The Ministry of Health of Saudi Arabia and
McMaster University Practice Guidelines provide clinicians and their patients with a basis
for rational decisions about the management
of obesity. Clinicians, patients, third-party
payers, institutional review committees, other
stakeholders, or the courts should never view
these recommendations as dictates. As described in other guidelines following the
GRADE approach, no guideline or recommendation can take into account all of the oftencompelling unique features of individual clinical circumstances. Therefore, no one charged
with evaluating clinicians’ actions should attempt to apply the recommendations from
these guidelines by rote or in a blanket fashion.
Management of Overweight and Obese
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Statements about the underlying values and
preferences, resources, feasibility, equity, acceptability as well as other qualifying remarks
accompanying each recommendation are its
integral parts and serve to facilitate an accurate interpretation. They should never be
omitted when quoting or translating recommendations from these guidelines if they influence the strength or direction of the recommendation.
Key questions
The following is a list of the clinical questions
selected by the Saudi expert panel and addressed in this guideline.
I. Non-pharmacological Management
1. Should psychotherapy (cognitive behavioural therapy) compared to no
psychotherapy be used for overweight and obese adults?
2. Should intensive lifestyle interventions compared to usual care be used
for overweight and obese adults?
3. Should lifestyle interventions compared to usual care be used for overweight and obese adults?
4. Should nutrition and physical activity
counselling compared to general
health information pamphlets be used
for overweight and obese adults?
5. Should isocaloric low fat compared to
moderate fat diet be used for overweight and obese adults?
6. Should physical activity compared to
no physical activity be used in obese
and overweight adults?
7. Should diet and physical activity compared to diet alone be used for overweight and obese adults?
8. Should portion-controlled diets be
used for overweight and obese
adults?
7
II. Pharmacological Management
9. Should metformin compared to no
metformin be used in overweight and
obese adults?
10. Should orlistat compared to no
orlistat be used for overweight and
obese adults?
III. Surgical Management
11. Should bariatric surgery be used for
overweight and obese adults?
Recommendations
Patient Values and Preferences: Across the
11 recommendations, the guideline panel
made a consistent judgment regarding obesity
as a priority problem due to the high prevalence of obesity in the Kingdom. Similarly,
with respect to values and preferences, panel
members agreed that there was probably no
important uncertainty about how much people value the main outcomes. The literature
search for values and preferences identified
the Australian study by Keating (2013), which
found that mean adjusted Utility Quality of
Life differences relative to healthy weight individuals (95% confidence interval) were,
0.012 (-0.022, -0.001) for overweight individuals, 0.020 (-0.041, 0.001) for class-I obese
individuals, -0.020 (-0.041, 0.001) class-II
obese individuals, and -0.069 (-0.099, -0.039)
for class-III obese individuals, suggesting an
inverse relationship between body weight and
quality of life.26
Cost Effectiveness: No cost effectiveness
studies were identified specific to Saudi Arabia. Studies from other countries were identified in the literature update for orlistat and
bariatric surgery.27,28 Panel members provided
their estimate of average unit costs for the
specific intervention in Saudi Arabian Riyal
(SR).
Management of Overweight and Obese
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8
I. Non-pharmacological Management
Question 1: Should psychotherapy-cognitive
behavioural therapy (CBT) compared to no
cognitive behavioural therapy be used for
overweight and obese adults?
Background: Multicomponent lifestyle interventions that include diet, exercise and behaviour modification are a common strategy
for weight loss, associated with moderate
weight reduction. 14 Psychotherapy is a core
component of behavioural modification. In
order to understand the role of psychotherapy, this question focuses on cognitive behavioural therapy (CBT), which is an established
psychotherapeutic treatment of choice for
weight loss.31 Cognitive behavioral approaches offer individuals the opportunity to identify
behavioural and thinking patterns that relate
to their particular weight problems.8 Cognitively oriented weight programmes have been
developed to reach the growing number of
overweight men and women since the 1970's.
9
More recently, randomized controlled trials
evaluating the impact of psychotherapy, have
identified cognitive behavioural therapy to
be superior
for
reducing
bingeeating, compared to other psychotherapies. 9
Summary of Findings: The question was based
on the 2013 NHMRC systematic review.13 The
updated literature search identified no new
studies related to CBT.
Benefits and Harms of the Option: The findings of 1 trial (total of 42 participants) found
low quality evidence that showed a decrease
in weight change (follow up: mean 18 months;
assessed with: mean kg) for the provision of
psychotherapy compared to no psychotherapy for overweight and obese adults (6.1 kg
lower, 95% CI 9.53 lower to 2.67 lower). 8
Resource Use: Resources required are probably not small as in Saudi Arabia psychologists
or trained primary care physician would be
needed, and training health care workers in
psychotherapy would be required. The panel
judged the provision of CBT to be cost effective, for overweight and obese adults.
Other considerations: The panel was concerned about applying this recommendation
to complex populations with suspected or
confirmed eating disorders who would require
specialized psychiatric assessment.
Balance between desirable and undesirable
consequences: Probably the beneficial effects
of CBT are large and no adverse consequences
are anticipated other than resource use requirements.
Recommendation 1:
The panel suggests cognitive behavioural
therapy (CBT) rather than no such therapy in
overweight and obese adults. (conditional
recommendation, low quality evidence)
Remarks:
This recommendation pertains to general
obese populations. Individuals with suspected or confirmed eating disorders or depression require specialized psychiatric assessment and management.
Implementation Considerations and Monitoring: Cognitive behavioural therapy as interpreted in this intervention is delivered by a
social worker with expertise in CBT and therefore requires consideration in terms of implementation and health professional training.
Subgroup considerations: Psychotherapy
should not be a substitute for psychiatric assessment in any individual with suspected or
confirmed eating disorder or depression.
Research Priorities:
The panel identified as a research priority
conducting a review of observational studies
in Saudi Arabia among both men and women
to assess the role of CBT in the management
of obesity.
Management of Overweight and Obese
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9
Question 2: Should intensive lifestyle interventions compared to usual care be used for
overweight and obese adults?
havioural information) for obese and overweight adults (RR 0.89, 95% CI 0.65 to 1.4;
absolute effect: 14 fewer events per 1000).10
Background: Lifestyle interventions are the
cornerstone of obesity treatment. Intensive
lifestyle interventions (ILI) involve more extreme dietary, physical and behavioural counselling, delivered by multidisciplinary teams of
nutritionists, physicians, behavioural therapists and exercise trainers. 10- 12 ILI typically
involves low to very low calorie diets (providing 800-1200 Kcal/day or <800 Kcal/day),
moderate to intense physical activity (≥30
minutes daily or the equivalent of consuming
1800-2500 Kcals/week), and individualized
behavioural goal setting, delivered at weekly
or bi monthly visits for 1 to several years. 10-12
ILI is therefore reserved for populations at
high risk of obesity. Outcomes for this intervention are consequently longer-term, such
as mortality and cardiovascular events, which
are direct patient important end-points.10-12
The findings of 1 trial (total of 505 participants) found high quality evidence that did
not rule out an increase or a decrease in Elevated Blood Pressure (systolic blood pressure
> 130 mmHg, diastolic BP greater than 85
mmHG) (follow up: mean 3 years; assessed
with: prevalence of elevated blood pressure)
for the provision of Intensive lifestyle interventions (diet and exercise) compared to usual or minimal care (general behavioural information) for obese and overweight adults (RR:
0.92, 95% CI: 0.69 to 1.3; absolute effect: 24
fewer events per 1000).10
Summary of Findings: The question was primarily based on the Finnish, Diabetes Prevention Study (DPS) and the Look AHEAD trial 10-12.
The updated literature search identified no
new studies.
Benefits and Harms of the Option: The findings of 1 trial (total of 505 participants) found
moderate quality evidence that did not rule
out an increase or a decrease in abdominal
obesity (≥102 cm in men, ≥88 cm in women)
(follow up: mean 4 years; assessed with:
prevalence) for the provision of intensive lifestyle interventions (diet and exercise) compared to usual or minimal care for obese and
overweight adults (OR: 0.869, 95% CI: 0.6 to
1.2; absolute effect: 27 fewer events per
1000). 10
The findings of 1 trial (total of 505 participants) found moderate quality evidence that
did not rule out an increase or a decrease in
low HDL cholesterol (low HDL cholesterol < 40
mg/dl or < 1.03 mmol/L) (follow up: mean 4
years; assessed with: prevalence of low HDL
cholesterol) for the provision of Intensive lifestyle interventions (diet and exercise) compared to usual or minimal care (general be-
The findings of 1 trial (total of 5645 participants) found moderate quality evidence that
did not rule out an increase or a decrease in
mortality (follow up: mean 10 years; assessed
with: events) for the provision of Intensive
lifestyle interventions (diet and exercise)
compared to usual or minimal care (general
behavioural information) for obese and overweight adults (RR 0.95, 95% CI 0.84 to 1.08;
absolute effect: 8 fewer events per 1000). 11
The findings of 1 trial (total of 505 participants) found low quality evidence that did not
rule out an increase or a decrease in cardio
vascular morbidity (acute coronary events,
coronary heart disease, stroke and hypertensive disease) (follow up: mean 10 years; assessed with: events) for the provision of Intensive lifestyle interventions (diet and exercise) compared to usual or minimal care (general behavioural information) for obese and
overweight adults (OR 1.02, 95% CI 0.70 to
1.56; absolute effect: 3 more events per
1000).11
The findings of 1 trial (total of 4867 participants) found moderate quality evidence that
showed a decrease in hospitalization heart
failure (follow up: mean 10 years) for the provision of Intensive lifestyle interventions (diet
and exercise) compared to usual or minimal
care (general behavioural information) for
obese and overweight adults (RR 0.86, 95% CI
Management of Overweight and Obese
Adults
64 to 1.09; absolute effect: 7 fewer events per
1000). 12
The findings of 1 trial (total of 4866 participants) found low quality evidence that
showed a decrease in weight (follow up: mean
9.6 years; assessed with: Kg) for the provision
of Intensive lifestyle interventions (diet and
exercise) compared to usual or minimal care
(general behavioural information) for obese
and overweight adults (MD 4 lower, 95% CI 5
lower to 3 lower). 12
Resource use: The panel judged resources required to not be small and probably not cost
effective.
Other considerations: The panel judged the
option to be probably acceptable to key
stakeholders and the feasibility to vary and
perhaps not be possible on a population level.
The panel judged the feasibility to be possible
in selected settings where human and financial resources are available as barriers include
the resources and availability of the health
care professionals to support intensive lifestyle modification. The panel judged the provision of CBT to probably increase health inequity.
Balance between desirable and undesirable
consequences: Most panel members thought
that the benefit in terms of prevention of diabetes and associated cost of care outweighs
the downsides. One panel member thought
the balance of desirable and undesirable consequences was uncertain because of concerns
about cost effectiveness and feasibility.
Research Priorities: Generation of local evidence for lifestyle modification is recommended (The research evidence used in this
guideline involving behaviours may be not
applicable for Saudi population which could
affect outcomes).
10
Recommendation 2:
The panel suggests using intensive lifestyle
modification rather than usual or minimal
care in overweight and obese adults. (conditional recommendation, moderate quality
evidence)
Remarks:
This recommendation pertains to those who
are at higher risk for obesity-related comorbidities such as diabetes as they would
benefit more from intensive lifestyle interventions.
Subgroup considerations: Patients at higher
risk for diabetes may benefit more from this
intervention.
Implementation Considerations and Monitoring: Implementation will require wellorganized, standardized lifestyle intervention
programs.
Question 3: Should lifestyle interventions
compared to other interventions be used for
overweight and obese adults?
Background: Lifestyle interventions are multicomponent treatments that involve promoting healthy lifestyle habits, dietary interventions, dietary counselling, physical exercise
training as well as psychological and behavioural interventions. Pharmacotherapies are
often an adjunct to lifestyle interventions, but
are not included in this definition of lifestyle
interventions. Lifestyle interventions are the
cornerstone of obesity management.14
Summary of Findings: The question was primarily based on the NHMRC systematic review 201313. The updated literature search
identified a Canadian systematic review and
meta-analysis.14
Benefits and Harms of the Option: The metaanalysis of 5 trials (total of 1149 participants)
found moderate quality evidence that did not
rule out an increase or a decrease in systolic
blood pressure (follow up: mean less than or
equal to 1 year; assessed with: mean change
Management of Overweight and Obese
Adults
11
(mmHg)) for the provision of lifestyle interventions compared to usual care for obese
and overweight adults (MD 1.95 lower, 95% CI
3.69 higher to 0.21 lower). 13
mended (The research evidence used in this
guideline involving behaviours may be not
applicable for Saudi population which could
affect outcomes).
The meta-analysis of 5 trials found moderate
quality evidence that showed a decrease in
diastolic blood pressure (follow up: mean less
than or equal to 1 year; assessed with: mean
change (mmHg)) for the provision of lifestyle
interventions compared to usual care for
obese and overweight adults (MD 3.24 lower,
95% CI 4.47 lower to 2.02 lower). 13
Recommendation 3:
The meta-analysis of 46 trials (total of 10829
participants) found moderate quality evidence
that showed a decrease in weight (follow up:
range < 12 months; assessed with: mean
change (kg)) for the provision of lifestyle interventions compared to usual care for obese
and overweight adults (MD 3.13 lower, 95% CI
3.88 lower to 2.38 lower). 14
The meta-analysis of 15 trials (total of 3556
participants) found moderate quality evidence
that showed a decrease in LDL cholesterol
(follow up: range <12 months; assessed with:
mmol/L)) for the provision of lifestyle interventions compared to usual care for obese
and overweight adults (MD 0.14 lower, 95% CI
0.29 lower to 0.002 lower). 14
Resource use: The panel judged lifestyle interventions to require a small cost and to be cost
effective.
Other considerations: The panel judged the
provision of lifestyle interventions to be both
feasible and acceptable and to have no impact
on health inequities.
Balance between desirable and undesirable
consequences: The benefits of lifestyle interventions clearly outweigh the harms, the resources required are small and the option was
judged to be cost effective, and the option is
both feasible and acceptable and has no impact on health inequities.
Research Priorities: Generation of local evidence for lifestyle modification is recom-
The panel recommends lifestyle intervention
rather than usual care alone in overweight
and obese adults. (strong recommendation,
moderate quality evidence)
Implementation Considerations and Monitoring: Lifestyle interventions should be tailored
to individual patient comorbidities.
Question 4: Should nutrition and physical
activity counselling compared to health education pamphlets be used for overweight and
obese adults?
Background: This brief intervention focuses
on nutrition and physical activity counselling,
the core components of lifestyle interventions, which are the cornerstone of obesity
management. Distinct from other lifestyle
approaches, this brief and simple intervention
is intended to be delivered by primary care
physicians within constraints of limited office
time and limited behavioural counselling
skills. The emphasis on brevity, and less intensive behavioural/psychotherapeutic aspects may favours tolerability for both patients and practitioners as evidenced by the
lower dropout rate (13%) compared to traditional lifestyle interventions (> 20%). 15
Summary of Findings: The question was based
on one moderate sized study (n= 273)15, derived from the NHMRC systematic review. 11,15
The updated literature search identified no
new studies.
Benefits and Harms of the Option: The findings of 1 trial (total of 273 participants) found
low quality evidence that showed an increase
in lost >5% body weight (follow up: mean 12
months; assessed with: prevalence) for the
provision of nutrition and physical activity
counselling compared to health education
pamphlets for obese and overweight adults
Management of Overweight and Obese
Adults
(OR 2.28, 95% CI 1.15 to 4.53; absolute effect:
107 more events per 1000). 15
The findings of 1 trial (total of 273 participants) found low quality evidence that did
showed an increase in getting engaged in
moderate physical activity (follow up: mean
12 months; assessed with: % subjects
achieved) for the provision of nutrition and
physical activity counselling compared to
health education pamphlets for obese and
overweight adults (OR: 1.93, 95% CI: 1.18 to
3.12; absolute effect: 161 more events per
1000). 15
The findings of 1 trial (total of 273 participants) found low quality evidence that did not
rule out an increase or a decrease in change in
waist circumference (follow up: mean 12
months; assessed with: cm) for the provision
of nutrition and physical activity counselling
compared to health education pamphlets for
obese and overweight adults (MD: 1.2, 95%
CI: 2.82 higher to 0.39 lower). 15
The findings of 1 trial (total of 273 participants) found low quality evidence that did not
rule out an increase or a decrease change in
systolic blood pressure (follow up: mean 12
months; assessed with: mean mmHg) for the
provision of nutrition and physical activity
counselling compared to health education
pamphlets for obese and overweight adults
(MD: 2.11 higher, 95% CI: 6.07 higher to 2.79
lower). 15
The findings of 1 trial (total of 273 participants) found low quality evidence that did not
rule out an increase or a decrease in the
change in diastolic blood pressure (follow up:
mean 12 months; assessed with: mmHg) for
the provision of nutrition and physical activity
counselling compared to health education
pamphlets for obese and overweight adults
(MD: 0.1 lower, 95% CI: 2.95 lower to 2.75
higher). 15
The findings of 1 trial (total of 273 participants) found low quality evidence that
showed a decrease in the change in total cholesterol (follow up: mean 12 months; assessed
with: mg/dL) for the provision of nutrition and
physical activity counselling compared to
12
health education pamphlets for obese and
overweight adults (MD: 3.9 lower, 95% CI:
5.96 higher to 13.75 lower). 15
Resource use: the panel judged the cost of
providing nutrition and physical exercise information to probably not have a small cost as
physicians must provide time to discuss tailored information and preparation of individualized information. The panel did judge the
option to be cost effective.
Other Considerations: The panel judged the
provision of nutrition and physical activity information to be acceptable and probably feasible with no impact on health inequities.
Balance between desirable and undesirable
consequences: There is health benefit without
downsides other than the cost of implementation and there is no doubt among members
that an individualized approach in overweight
and obese individuals is better than a generic
approach.
Recommendation 4:
The panel recommends individualized counseling interventions rather than generic educational pamphlets in overweight or obese
adults. (strong recommendation, low quality
evidence)
Research Priorities: More research about the
methods of individualized interventions is required.
Question 5: Should iso-caloric low-fat compared to moderate-fat diet be used for
overweight and obese adults?
Background: People with diabetes are advised
to reduce fat intake in order to decrease their
risk of cardiovascular disease. There is debate
about the feasibility of adherence to and
benefits of very low fat diets for improving
cardiovascular risk and achieving weight loss.
One trial conducted in Iran that was reported
in the NHMRC review found significant reduction (P<0.001) in waist circumference of
Management of Overweight and Obese
Adults
5.5 cm (SD 2.4) in the moderate fat versus
low fat group.11 The authors conclude that
better adherence to the more appetizing
moderate fat diet was the reason for success,
which would have relevance regarding this
option for the Saudi context.16
Summary of Findings: Three studies 16-18 informing this question are derived from the
NHMRC systematic review 13. Meta-analysis
was not provided in the original review but
was undertaken for this report for estimates
of effect on weight and lipids (HLD, LDL and
Triglycerides). One of the RCTs reported additional outcomes of systolic and diastolic blood
pressure 16 that were not evaluated by the
other trials.17,18 The updated literature search
identified no new studies.
Benefits and Harms of the Option: The metaanalysis of 3 trials (total 159 participants)
found low quality evidence that did not rule
out a reduction or increase in mean weight
change (follow-up mean 6-7 months) for use
of isocaloric low-fat compared to moderatefat diets in overweight and obese adults
(mean 0.79 kilograms lower; 95% CI: 1.99
lower to 0.49 higher). 16-18
The meta-analysis of 3 trials found low quality
evidence that did not rule out a reduction or
increase in mean total cholesterol change (follow-up 6-18 months) for use of isocaloric lowfat compared to moderate-fat diets in overweight and obese adults (mean 0.21 mmol/L
lower; 95% CI: 8.86 lower to 8.84 higher). 16-18
The meta-analysis of 3 trials found low quality
evidence that did not rule out a reduction or
increase in mean HDL cholesterol change (follow-up 6-18 months) for use of isocaloric lowfat compared to moderate-fat diets in overweight and obese adults (mean 0.03 mmol/L
lower; 95% CI: 0.62 lower to 0.56 higher).
The meta-analysis of 3 trials found low quality
evidence that did not rule out a reduction or
increase in mean Triglycerides change (followup 6-18 months) for use of iso-caloric low-fat
compared to moderate-fat diets in overweight
and obese adults (mean 0.2 mmol/L higher;
95% CI: 0.05 lower to 0.45 higher).
13
The findings of one trial (89 total participants)
found low quality evidence that did not rule
out a reduction or increase in mean systolic
blood pressure change (follow-up 14 months)
for use of iso-caloric low-fat compared to
moderate-fat diets in overweight and obese
adults (mean 2.8 mmHg lower; 95% CI: 11.4
lower to 5.8 higher). 16
The findings of one trial (89 total participants)
found low quality evidence that did not rule
out a reduction or increase in mean diastolic
blood pressure change (follow-up 14 months)
for use of iso-caloric low-fat compared to
moderate-fat diets in overweight and obese
adults (mean 4.7 mmHg lower; 95% CI: 9.1
lower to 0.2 higher). 16
No harms were identified.
Resource Use: Individual dietary programs to
create an energy deficit may be more costeffective than broad general practitioner advice if delivered by an accredited practicing
dietitian. Costs are associated with the use of
specialized diets. Purchasing very low-fat diet
items to replace meals may be costly for individuals and their use requires frequent monitoring by healthcare professionals. The relevant healthcare professional to monitor use
may be a general practitioner with special
training, dietitian or specialist nurse, depending on access to the type of provider.
Other Considerations: The panel judged the
use of low-fat diets both acceptable and feasible. The panel judged the impact on inequity to be not applicable. The panel judged that
there is no important uncertainty or variability
about how much people value this outcome.
Balance between desirable and undesirable
Consequences: The panel judged the balance
between desirable and undesirable consequences as uncertain due to lack of information on undesirable effects.
Research Priorities: The panel suggests randomized controlled trials be done with adequate follow-up duration that compare iso-
Management of Overweight and Obese
Adults
caloric diets with fat content lower than 20%,
approximately 20% and approximately 30%.
Recommendation 5:
The panel makes no clinical recommendation
regarding iso-caloric low-fat versus moderate-fat diets. The panel suggests randomized controlled trials be done with adequate
follow-up duration that compare iso-caloric
diets with fat content lower than 20%, approximately 20% and approximately 30%.
(low quality evidence)
Remarks:
Panel members judged that there was not
enough evidence to choose one option over
another. If any diet is used, fat content
should be determined according to AMDR
and fat subtypes should be defined (saturated fatty acids, trans fatty acids, Omega 3 and
6 fatty acids) in order to evaluate benefits or
harms.
Questions 6 & 7: Should physical activity and
diet compared to diet or physical activity
alone be used for overweight and obese
adults?
Summary of Findings: Studies informing these
questions are derived from the NHMRC systematic review and include two Cochrane reviews 19,36 and four more recent randomized
controlled trials. 19,21,22,34,35,36 The updated literature search identified no new studies.
Benefits and Harms of the Option:
Physical activity versus no physical activity:
The meta-analysis of 2 trials (total 351 participants) found low quality evidence that did not
rule out a reduction or increase in end study
prevalence of diabetes (follow-up 2-4 years)
for use of exercise compared to no exercise in
overweight and obese adults (OR = 0.67; 95%
CI 0.29 to 1.57; absolute effect 100 fewer
events per 1000). 36
14
The finding of one trial (total 179 participants)
found low quality evidence that did not rule
out a reduction or increase in mean waist circumference change (follow-up mean 12
months) for use of exercise compared to no
exercise in overweight and obese adults
(mean 0.1 cm higher; 95% CI 0.35 higher to
1.34 lower). 21
Findings from one trial (total 179 participants)
found very low quality evidence that did not
rule out a reduction or increase in mean 400meter per second gait speed change (followup mean 12 months) for use of exercise compared to no exercise in overweight and obese
adults (mean 0.009 m/sec higher; 95% CI not
available). 21
Findings from one trial (total 133 participants)
found low quality evidence of a reduction in
mean percentage body fat change (follow-up
mean 2 years) for use of exercise compared to
no exercise in overweight and obese adults
(mean 1.61 % lower; 95% CI 3.27 lower to 0.5
lower). 22
Findings from one trial (total 133 participants)
found low quality evidence of an increase in
mean bench press capacity change (follow-up
mean 2 years) for use of exercise compared to
no exercise in overweight and obese adults
(mean 6.6 kg higher; 95% CI 8.29 higher to
4.91 higher). 22
The meta-analysis of 2 trials (total 270 participants) found moderate quality evidence of a
reduction in mean weight change (follow-up
2-4 years) for use of exercise compared to no
exercise in overweight and obese adults
(mean 2.03 kg lower; 95% CI 1.23 lower to
2.82 lower). 19
Physical activity and diet versus diet:
The meta-analysis of 15 trials (total 1479 participants) found very low quality evidence of a
reduction in mean body weight change (follow-up mean 1 year) for use of diet and physical activity compared to diet alone in overweight and obese adults (mean 0.65 kg lower;
95% CI 0.97 lower to 0.33 lower).19
Management of Overweight and Obese
Adults
The meta-analysis of 6 trials (total 615 participants) found very low quality evidence that
did not rule out a reduction or increase in
mean systolic blood pressure change (followup mean 1 year) for use of diet and physical
activity compared to diet alone in overweight
and obese adults (mean 0.11 mmHg lower;
95% CI 1.45 lower to 1.25 higher).19
Findings from one trial found moderate quality evidence of a reduction in knee pain change
(follow-up mean 2 years) for use of diet and
physical activity compared to diet alone in
overweight and obese adults (OR = 2.95 for %
achieving > 30% reduction in WOMAC score;
95% CI 1.68 to 5.19; absolute effect 238 more
events per 1000). 35
The meta-analysis of 6 trials (total 615 participants) found very low quality evidence that
did not rule out a reduction or increase in
mean diastolic blood pressure change (followup mean 1 year) for use of diet and physical
activity compared to diet alone in overweight
and obese adults (mean 0.94 mmHg lower;
95% CI 1.89 lower to 0.0 higher). 19
The meta-analysis of 6 trials (total 619 participants) found very low quality evidence that
did not rule out a reduction or increase in
mean cholesterol change (follow-up 1 year)
for use of diet and physical activity compared
to diet alone in overweight and obese adults
(mean 0.03 mmol/L higher; 95% CI 0.07 lower
to 0.13 higher). 19
15
barrier to outdoor exercise. According to the
panel, women experience barriers to physical
activity, as they require accompaniment. For
diet, costs are associated with the use of specialized diets. Purchasing low-energy diet
items to replace meals may be costly for individuals and their use requires frequent monitoring by healthcare professionals. The relevant healthcare professional to monitor use
may be a general practitioner, dietician or
specialist nurse, depending on access to the
type of provider. Health professional visit fees
would also therefore need to be considered
among the resources required. The panel
estimated costs for such providers were: general physician 300 SR; diabetic educator 250
SR; nutritionist 250 SR; and behavioural specialist 200 SR per visit.
Other considerations: The panel judged that
exercise and diet would be both feasible to
implement and acceptable to most stakeholders. The panel judged that there is no important uncertainty or variability about how
much people value this outcome.
Balance between desirable and undesirable
consequences: The panel judged that desirable consequences clearly outweigh undesirable consequences in most settings. The panel
judged that for exercise alone and diet alone,
though, the desirable anticipated effects due
to exercise or diet alone are probably not
large.
Recommendations 6 & 7:
Findings from one trial (total 54 participants)
found very low quality evidence that did not
rule out a reduction or increase in mean bone
density change (follow-up mean 1 year) for
use of diet and physical activity compared to
diet alone in overweight and obese older
adults (mean 0.016 g/m2 higher; 95% CI 0.004
lower to 0.036 higher). 34
No harms outcomes were identified.
Resource Use: For physical activity and exercise, out of pocket expense for cost and travel
to indoor recreation centres are prohibitive
(1000-3000 SR per month), hot weather is a
The panel recommends physical activity rather than no physical activity in overweight
and obese adults. (strong recommendation,
low quality evidence)
The panel recommends physical activity in
addition to diet rather than a diet alone in
overweight or obese adults. (strong recommendation, low quality evidence)
Management of Overweight and Obese
Adults
Question 8: Should portion-controlled diet
compared to non-portion controlled diet be
used for obese and overweight adults?
Background: Portion-controlled meals can be
commercially prepared, specifically designed
for convenience, ease of incorporation into an
individual’s lifestyle, and are intended to improve long-term dietary adherence. This
question addresses the effect of portioncontrolled diet against standard diet and is
based on a single, long-term (36 month) RCT
(n= 126). 23
Summary of Findings: This question was based
on one randomized controlled trial identified
in the NHMRC systematic review. 23 The updated literature search identified no new
studies.
Benefits and Harms of the Option: Findings
from one trial (total 48 participants) found
very low quality evidence that did not rule out
a reduction or increase in end of study prevalence of > 10% weight loss change (follow-up
mean 36 weeks) for use of portion-controlled
diet compared to non-portion controlled diet
in overweight or obese adults (OR = 6.54
achieving >10% weight loss; 95% CI 0.75 to
56.92; absolute effect 231 more per 1000). 23
Findings from one trial (total 48 participants)
found very low quality evidence of a reduction
in mean systolic blood pressure change (follow-up mean 36 weeks) for use of portioncontrolled diet compared to non-portion controlled diet in overweight or obese adults
(mean 10.6 mmHg lower; 95% CI 18.67 lower
to 2.88 lower).
Findings from one trial (total 48 participants)
found very low quality evidence that did not
rule out a reduction or increase in mean total
cholesterol change (follow-up mean 36
weeks) for use of portion-controlled diet
compared to non-portion controlled diet in
overweight or obese adults (mean 14.3 mg/dL
lower; 95% CI 35.3 lower to 6.55 higher).
16
Findings from one trial (total 42 participants)
found low quality evidence that did not rule
out a reduction or increase in mean prevalence of reduced medication use (follow-up 36
months) with use of portion-controlled diet
compared to non-portion controlled diet in
overweight or obese adults (OR = 7.9 achieving reduced medication; 95% CI 152.27 to
0.42; absolute effect 202 more events per
1000).
Findings from one trial (total 48 participants)
found very low quality evidence of a reduction
in mean diastolic blood pressure change (follow-up 36 weeks) for use of portioncontrolled diet compared to non-portion controlled diet in overweight or obese adults
(mean 5.6 mmHg lower; 95% CI 10.36 lower
to 0.84 lower).
No harms were identified.
Resource Use: Costs are associated with the
use of specialized diets. The panel judged resources required for commercial preparations
(~2000 SR per month) are most likely not
small. The panel also identified that it is uncertain if resources required are small, owing
to lack of data on what would be the cost associated with home-made portion control diets. Purchasing diet items to replace meals
may be costly for individuals and their use
requires frequent monitoring by healthcare
professionals. The relevant healthcare professional to monitor use may be a general practitioner, dietician or specialist nurse, depending
on access to the type of provider. Health professional visit fees would also therefore need
to be considered. The panel estimated costs
for such providers were: general physician
300 SR; diabetic educator 250 SR; nutritionist
250 SR; and behavioural specialist 400 SR.
Other Considerations: The panel judged the
option both feasible and acceptable to key
stakeholders to implement. The panel judged
that increased associated costs would likely
cause health inequities to increase. The panel
judged that there is no important uncertainty
Management of Overweight and Obese
Adults
regarding the variability about how much
people value this outcome.
Balance between desirable and undesirable
consequences: The panel judged that the balance between desirable and undesirable consequences is closely balanced or uncertain as
it is uncertain whether the desirable anticipated effects are large and whether the undesirable effects are small.
Research Priorities: The panel suggests more
research on portion controlled diet strategies
for weight loss
Recommendation 8:
The panel does not make a clinical recommendation on portion-controlled diets. The
panel suggests that more research be done.
(very low quality evidence)
Implementation Considerations and Monitoring: Standardization of diet if made at home
may be a barrier for successful implementation.
II. Pharmacological Management
Question 9: Should metformin compared to
no metformin be used for overweight and
obese adults?
Background: The cornerstone of obesity
treatment is lifestyle changes. In view of the
low success rate in achieving weight loss and
even lower success rate for maintaining this
weight loss, drug therapy for obesity in conjunction with lifestyle changes are often used.
14,31,33,40
Evidence suggests that metformin therapy
alone contributes to weight loss14, although
its use for obesity is considered off-label in
most jurisdictions.
Evidence Summary: Evidence informing this
question is derived from the NHMRC review
and includes a meta-analysis on insulinsensitizing dugs for weight loss in women
pooled across 8 trials 24 (Appendix 2 Guideline
question 9, Figure1) as well as the Diabetes
Prevention Program Outcomes Study (n=
17
1938). 41 Our literature update also identified
one RCT on hypertensive patients using low
dose metformin.42
Benefits and Harms of the option: The metaanalysis of 8 RCTs (N= 372) found moderate
quality of evidence for a clinically small decrease in BMI (0.98 Kg/m2± 0.53) associated
with metformin use (850 mg BID over 2-12
months) among obese women.24
One moderate quality RCT (The Diabetes Prevention Program, n = 1260) found that systolic
blood pressure was insignificantly higher
among those at risk for diabetes who received
metformin 850 mg BID over 5.7 years (0.4
mmHg ±1.6) 41
One moderate quality RCT (The Diabetes Prevention Program, n = 1260) found that diastolic blood pressure was insignificantly higher
among those at risk for diabetes who received
metformin 850 mg BID over 5.7 years (0.7
mmHg ± 0.68) 41
One moderate quality RCT (The Diabetes Prevention Program, n = 1260) found that total
cholesterol was insignificantly lower among
those at risk for diabetes who received metformin 850 mg BID over 5.7 years (0.01 mmHg
± 0.06) 41
One moderate quality RCT (The Diabetes Prevention Program, n = 1938-for this outcome)
found that the incidence of diabetes decreased by 30 per 1000 among those at risk
for diabetes who received metformin 850 mg
BID over 5.7 year 41
One moderate quality RCT identified in our
update (n= 360) found a decrease 0.7 kg ±
1.59 among hypertensive patients receiving
metformin 300 mg od for 12 weeks.
The quality of evidence for harms is moderate. Results are described narratively due to
reporting inconsistencies and are related
mainly to gastrointestinal side-effects (nausea, abdominal cramps and diarrhoea).42
Management of Overweight and Obese
Adults
Resource Use: The panel judged resources
required for metformin to be small and cost
effectiveness to be uncertain. Panel estimates
20 SR per month for metformin, 850 mg BID
per adult.
Other considerations: The panel judged metformin to be feasible and acceptable and that
benefits may be larger in patients with prediabetes and those with risk factors for diabetes.
Balance between desirable and undesirable
consequences: The panel judged that the desirable anticipated benefits of metformin are
not large, that those with pre-diabetes and
other diabetes risk factors may experience
larger benefits, that undesirable side-effects
vary, that costs associated with metformin are
small, that it is feasible and acceptable to implement. Overall, the panel judged that desirable consequences probably outweigh undesirable consequences in most settings.
Recommendation 9:
The panel suggests metformin in obese or
overweight adults. (conditional recommendation, low quality evidence)
Research Priorities: Future RCTs are required
on unselected obese and overweight populations that report all patient-important outcomes (e.g. quality of life, function, morbidity
and mortality) rather than surrogate outcomes only. Economic analysis in the Saudi
Arabian health care system is recommended.
Question 10: Should orlistat compared to no
orlistat be used for overweight and obese
adults?
Background: The cornerstone of obesity
treatment is lifestyle changes. In view of the
low success rate in achieving weight loss and
even lower success rate for maintaining this
weight loss, drug therapy for obesity in conjunction with lifestyle changes is often advised. 31,33 Orlistat is a lipase inhibitor, which
prevents absorption of approximately 25% of
18
fat consumed and is the main anti-obesity
drug approved for long-term treatment of
obesity.29 Evidence suggests that orlistat therapy alone contributes to weight loss. 13 In
some jurisdictions (e.g. U.S.) orlistat is over
the counter, suggesting a high safety profile.
Summary of Findings: A meta-analysis from
the NHMRC review across 11 trials informs
this question. Additionally, an older Cochrane
review based on 4 RCTs derived from the
NHMRC provides descriptive summaries for
adverse events, mortality and myocardial infarctions.13,27
Benefits and Harms of the option: Moderate
quality evidence from a meta-analysis of 11
RCTs (n= 2058) found that treatment with
orlistat 120 mg TID over 3.5 years decreased
systolic blood pressure by 1.82 mm Hg ±
0.43.13
Moderate quality evidence from a metaanalysis of 11 RCTs (n= 2058) found that
treatment with orlistat, 120 mg TID over 3.5
years decreased diastolic blood pressure by
1.56 mm Hg ± 0.69.13
Moderate quality evidence from a metaanalysis of 11 RCTs (n= 2080-for this outcome)
found that treatment with orlistat, 120 mg TID
over 3.5 years decreased body weight by 3.38
kg ± 0.41 13
Low quality of evidence for adverse events is
summarized descriptively from 4 trials as reported in a Cochrane review.25 The majority of
individuals (up to 73%) in the orlistat groups
reported side-effects of steatorrhoea, fatty
faecal incontinence, frequent or urgent bowel
movements.
Evidence for mortality is low and reported
descriptively. There were two deaths in 3
RCTs in the orlistat group over 12 months
compared to no deaths in the placebo group.
25
Evidence for myocardial infarction is low and
reported descriptively. There were two myocardial infarctions in 2 RCTs, compared to 1 in
the placebo groups. 25
Resource Use: The panel judged resource use
associated with orlistat to be small, and prob-
Management of Overweight and Obese
Adults
ably cost effective and that economic analyses
in the Saudi Arabian context be undertaken.
Other considerations: The panel judged that
impact on health inequity would probably increase and therefore recommended in settings with limited resources that the opposite
(i.e. not using orlistat) may be equally reasonable. The panel judged that orlistat is feasible
and acceptable to implement and recommends that patients should be advised to expect adverse events and to avoid fatty meals,
additionally since orlistat decreases absorption of fat soluble vitamins, that supplementation may be warranted.
Balance between desirable and undesirable
consequences: The panel judged that overall,
benefits of orlistat probably outweigh anticipated important adverse events and that implementation is feasible and acceptable. The
panel recommends that patients be advised of
adverse events, to avoid fatty meals and to
consider vitamin supplementation. The panel
judged that impact on health inequities is
probably increased and that where resources
are limited not using orlistat would be also
reasonable.
Recommendation 10:
The panel suggests orlistat in obese and
overweight adults. (conditional recommendation, moderate quality evidence)
Research Priorities: Economic analysis in Saudi
Arabian health care system is recommended.
Studies investigating whether and when to
use multivitamin supplementation with
orlistat is also recommended.
19
surgery include; bleeding (0.5%), thromboembolic events (0.8%), wound complications
(1.8%), deep infection-abscess or leak (2.1%),
pulmonary complications (6.2%), miscellaneous complications (4.8%), cholecystitis and
mortality (0.52%). 43 Large observational studies of bariatric surgery, confirms effectiveness
of major weight reduction and improvement
in co-morbidities, which are reported in small,
randomized trials.45
Summary of Findings: Our literature update
identified a meta-analysis of bariatric surgery
within the 2014 Cochrane review by
Colquitt.41 However comparisons within this
review did not address the surgical technique
and comparator of interest to panel members
(sleeve gastrectomy versus medical therapy).
Panel members identified The RCT by Schauer, 2014 that specifically evaluated sleeve gastrectomy in comparison to medical therapy as
important for consideration in the Saudi context and this RCT informs this question. 44
Benefits and Harms of the option: Moderate
quality of evidence from one RCT (n= 89) is
found for mean systolic blood pressure reduction of 5.7 mmHg (± 8.3) in the surgically
treated group compared to the medically
treated group over 3 years. 44
Moderate quality of evidence from one RCT
(n= 88) found a reduction of those with glycosylated hemoglobin > 6% of 200 fewer per
1000 when treated surgically treated versus
medically over 3 years (NNT = 5, range 17 to
3). 44
Question 11: Should bariatric surgery compared to non-surgical therapies be used for
overweight and obese adults?
Moderate quality of evidence from one RCT
(n= 89) is found for weight reduction of 21 kg
(± 6) in the surgically treated group compared
to the medically treated group over 3 years. 42
Moderate quality of evidence from one RCT
(n= 88) found an increase of anemia 209 more
per 1000 among those treated surgically compared to those treated medically over 3 years
(NNT = 5, range 142 to 2). 44
Background: Bariatric surgery in general carries risk of morbidity and peri-operative mortality. It is therefore considered when other
treatments have failed. Risks with bariatric
Other considerations: The panel identified
that data are limited to sleeve gastrectomy
techniques. The panel judged that health inequities would probably increase in relation to
III. Surgical Management
Management of Overweight and Obese
Adults
surgical interventions, that implementation
considerations need to address pre-operative
screening requirements by trained physicians
for evaluation of comorbidities and other
causes of obesity, including eating disorders
and depression and that post-operative lifelong follow-up by interdisciplinary teams (surgeon, clinical nutritionist, psychotherapist) are
required to prevent and manage dietary deficiencies and other complications and these
health professional resources represent additional implementation considerations. The
panel judged that it is feasible and acceptable
to implement.
Resource Use: The panel considered resource
associated with bariatric surgery-sleeve gastrectomy to be not small and probably costeffective
Balance between desirable and undesirable
consequences: Overall, the panel judged that
the desirable consequences of this surgical
intervention probably outweigh undesirable
consequences in most settings. Anticipated
beneficial effects are large, risks are probably
small. Costs are judged to be small and probably cost-effective. The intervention is acceptable and feasible. The panel identified
that data are limited to sleeve gastrectomy,
that there are inequities associated with this
intervention and that implementation requires consideration of health professional
resources for screening and interdisciplinary
post-operative follow-up.
20
Recommendation 11:
The panel suggests using bariatric surgery in
obese adults (BMI ≥40 or ≥35 with comorbidities). (conditional recommendation, moderate quality evidence)
Remarks:
This recommendation pertains to individuals
with larger BMI since anticipated benefits
are larger in the setting of individuals who
are at higher health risk due to obesity when
considering risks associated with surgery. It
also considers implementation requirements
of interdisciplinary teams to prevent and
manage lifelong dietary deficiencies, complications and weight management.
Research priorities: Long-term evaluation of
benefits and complications related to bariatric
surgery are required, as well as evidence from
studies involving individuals with lower BMI
(30-35).
Management of Overweight and Obese
Adults
Questions initially identified as potentially
relevant but not addressed in these guidelines
1. Should laparoscopic adjustable gastric
band surgery rather than no laparoscopic adjustable gastric band surgery
be used in obese adults? – The panel
members thought that this procedure
was not relevant in the Saudi context
as this has been replaced by other
surgical procedures.
2. Should intensive lifestyle intervention
rather than group education sessions
be used in overweight and obese
adults? – The panel members thought
that group education is part of intensive lifestyle modification and does
not need to be addressed separately
3. Should motivational interviewing rather than no motivational interviewing be used in overweight and obese
adults? – The panel members thought
that this intervention is part of intensive lifestyle modification intervention
and does not need to be addressed
separately.
4. Should exercise and diet rather than
exercise alone be used in obese and
overweight adults? – The panel mem-
21
bers thought that this question is not
relevant as diet should be part of the
management of obesity irrespective,
and that individuals motivated
enough to exercise would most likely
already use diet.
Priority questions for the future update of
this guideline
The following questions were identified by the
guideline panel as priority to be answered in
the future update of this guideline:
1. Should more novel anti-obesity drugs
compared to classical anti-obesity
drugs be used in overweight and
obese adult patients?
2. Should specific types of bariatric surgery be offered to obese Saudi patients, as compared to the most
commonly performed surgery?
3. Should herbal and traditional/cultural
medicine (whether locally produced
or imported from abroad) be encouraged in overweight and obese adult
patients?
4. What are optimal intervention strategies for the prevention of obesity?
5. What are optimal strategies for the
management and prevention of obesity in children and adolescents?
Management of Overweight and Obese
Adults
22
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17. Milne RM, Mann JI, Chisholm AW, Williams SM. Long-term comparison of three dietary
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18. Tsihlias EB, Gibbs AL, McBurney MI, Wolever TM. Comparison of high-and low-glycemic-index
breakfast cereals with monounsaturated fat in the long-term dietary management of type 2
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19. Shaw KA, Gennat HC, O'Rourke P, Del Mar C. Exercise for overweight or obesity. The Cochrane
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20. Thomas D, Elliott EJ, Naughton GA. Exercise for type 2 diabetes mellitus. Cochrane Database Syst
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21. Manini TM, Newman AB, Fielding R, et al. Effects of exercise on mobility in obese and nonobese
older adults. Obesity 2010;18:1168-75.
22. Schmitz KH, Hannan PJ, Stovitz SD, Bryan CJ, Warren M, Jensen MD. Strength training and
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23. Cheskin LJ, Mitchell AM, Jhaveri AD, et al. Efficacy of Meal Replacements Versus a Standard
Food-Based Diet for Weight Loss in Type 2 Diabetes A Controlled Clinical Trial. The Diabetes
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24. Nieuwenhuis-Ruifrok A, Kuchenbecker W, Hoek A, Middleton P, Norman R. Insulin sensitizing
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25. Siebenhofer A, Jeitler K, Horvath K, Berghold A, Siering U, Semlitsch T. Long‐term effects of
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Associated with Overweight and Obesity: The Australian Diabetes, Obesity, and Lifestyle Study.
Obesity 2013; 21: 652-5.
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28. Picot J, Jones J, Colquitt JL, Gospodarevskaya E, Loveman E, Baxter L, et al. The clinical
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29. National Institute for Clinical Excellence. Clinical Practice Guideline Number 9. Eating disorders –
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31. Stegenga H, Haines A, Jones K, Wilding J. Identification, assessment and management of overweight and obesity: Summary of updated NICE guidance. British Medical Journal. 2014;
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32. Leblanc ES, O'Connor E, Whitlock EP, Patnode CD, Kapka T. Effectiveness of primary carerelevant treatments for obesity in adults: A systematic evidence review for the U.S. preventive
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33. Al-Sherri FS, Moqbel M, Al-Sharani A, Al-Khalidi A, Abu-Melha W. Management of obesity: Saudi
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34. Villareal D, Chode S, Parimi N, et al. Weight loss exercise or both and physical function in obese
older adults. New England Journal of Medicine. 2011; 364(13): 1218-1224.
35. Jenkinson C, Doherty M, Avery A, et al. Effects of dietary intervention and quadriceps strengthening exercises on pain and function in overweight people with knee pain: Randomised controlled trial. British Medical Journal. 2009; 339(b2170): 1-10.
36. Orozco LJ. Buchleitner AM, Gimenez-Perez G, Roque i Figuls M, Richter B. Mauricio D. Exercise or
exercise and diet for preventing type 2 diabetes mellitus. The Cochrane Library, 2008.
37. Pi-Sunyer X. Reduction in weight and cardiovascular disease in individuals with type 2 diabetes:
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38. Foster G, Borradaile K, Sanders M, et al. A randomized study on the effect of weight loss on
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39. Wing R, Bahnson J, Bray G, et al. Long term effects of a lifestyle intervention on cardiovascular
risk factors in individuals type 2 diabetes; four year results. Look AHEAD trail. Archives of Internal Medicine. 2010; 170 (17): 1566-1575.
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behavioural and pharmacoligic interventions to manage overweight and obesity in adults in primary care. Canadian Medical Association Journal. 2015; 187 (3).
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42. He Z, James CJ, et al. - Metformin-based treatment for obesity-related hypertension: A randomized, double-blind, placebo-controlled trial. Journal of Hypertension. 2012; 30 (7): 1430-1439.
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44. Schauer P, Bhatt D, Kirwan J, Wolski K, Brethauer S, et al. Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 3-Year Outcomes. 2014. New England Journal of Medicine. 370: 21:
2002-13.
45. Buchwald H, Estok R, Fahrbach K, Banel D, Jensen M. Weight and Type 2 Diabetes after Bariatric
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46. Alsahmari, Y. Attitudes and Practices of Primary Care Physicians in the Management of Overweight and Obesity in Eastern Saudi Arabia. International Journal of Health Sciences, Qassim
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48. Torgerson J, Hauptman J, Boldrin M, Sjostrom L. XENical in the Prevention of Diabetes in Obese
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prevention of type 2 diabetes in obese patients. Diabetes Care. 2004 27, (1): 155-61
Management of Overweight and Obese
Adults
Appendices
1. Appendix 1: Evidence-to-Decision Frameworks
2. Appendix 2: Search Strategies and Results
25
Management of Overweight and Obese
Adults
26
Appendix 1: Evidence to Decision Frameworks
Guideline Question 1: Should psychotherapy (CBT) compared to no psychotherapy be used for overweight and obese adults?
Population
Intervention
Comparison
Outcomes
Obese women (BMI> 30)
Psychotherapy- Cognitive behavioral therapy
2 hour sessions weekly for 10 weeks delivered by a social worker
Group education sessions on nutrition and exercise delivered by a multidisciplinary team
Weight change at 18 months
Background:
Multicomponent lifestyle interventions that include diet, exercise and behaviour modification are a common strategy for weight loss, associated with
moderate weight reduction. 14 Psychotherapy is a core component of behavioural modification. In order to understand the role of psychotherapy, this
question focuses on cognitive behavioural therapy, which is an established psychotherapeutic treatment of choice for weight loss.29 Cognitive behavioral
approaches offer individuals the opportunity to identify behavioural and thinking patterns that relate to their particular weight problems.9 Cognitively oriented weight programmes have been developed to reach the growing number of overweight men and women since the 1970's. 8 More recently, randomized controlled trials evaluating the impact of psychotherapy, have identified cognitive behavioural therapy to be superior for reducing bingeeating, compared to other psychotherapies. 9
Evidence summary:
Overall certainty of evidence is low for psychotherapy-cognitive behavioural therapy type, although statistically greater weight loss (6.1 kg ±3.4)
sustained at 18 months was observed, this is a single small study limited by imprecision and a high drop-out rate after randomization. 8 This study
was derived from the NHMRC systematic review, there were no updates identified in our literature search. Expert KSA panel opinion suggests that
acceptability of this option is low among the Saudi population. Low tolerance for psychotherapy is consistent with the high dropout rate (22% after randomization). Knowledge relative to cognitive treatment of obesity was significantly higher in the cognitive group compared to the control
group (p<.001). Other outcomes (physiological parameters, self-efficacy) that could be considered in this context were not measured or reported
in this study.
Management of Overweight and Obese
Adults
27
Evidence to Decision Framework: Should psychotherapy compared to no psychotherapy be used for overweight and obese adults?
Criteria
Problem
Is there a problem
priority?
Judgements
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
○ No included
studies
What is the overall
certainty of this
evidence?
○ Very low
● Low
○ Moderate
○ High
○ Important uncer-
Benefits &
harms of the
options
tainty or variability
Additional considerations
Research evidence
)
Obesity in Saudi Arabia is a growing health concern. Obese and overweight adults represent over 70% of the population.24 Females are significantly more obese than males with a prevalence of 44%, compared to
26%, while overweight is significantly more prevalent among males
(42.4%) compared to females (31.8%). 25 Obesity and overweight are well
known risk factors for diabetes, coronary artery disease, hypertension,
breathing and sleep disorders, as well as impaired quality of life
The relative importance or values of the main outcomes of interest:
Outcome
Weight change
Relative importance
CRITICAL
Certainty of the evidence
(GRADE)
⨁⨁◯◯
LOW
Summary of findings:
Outcome
Without psychotherapy
With psychotherapy
Difference
(95% CI
The mean weight
change in the
intervention group
was 6.1 lower
(9.53 lower to
2.67 lower)
mean 6.1
lower
(9.53 lower
to 2.67 lower)
○ Possibly imIs there important
uncertainty about
how much people
value the main outcomes?
portant uncertainty
or variability
○ Probably no important uncertainty
of variability
● No important
uncertainty of variability
Weight
change
The mean weight
change in the
control group was
0.6 kg
Relative
effect
(RR)
(95%
CI)
-
Patient values and preferences:
Impact of obesity (BMI
≥ 26 mg/kg2) on healthrelated quality of life
(across multiple utility
measures: EQ5D, EuroQol, VAS and SF6D)
suggests significantly
more problems with
pain, mobility, role limitations and social functioning compared to
those who are pre-obese
or overweight.
(Keating et al. 2007)
Management of Overweight and Obese
Adults
Criteria
28
Judgements
○ No known undesirable
Resource use
Are the desirable
anticipated effects
large?
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
Are the undesirable
anticipated effects
small?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Are the desirable
effects large relative to undesirable
effects?
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
Are the resources
required small?
○ No
● Probably no
Research evidence
Additional considerations
Management of Overweight and Obese
Adults
Criteria
29
Judgements
Research evidence
Additional considerations
○ Uncertain
○ Probably yes
○ Yes
○ Varies
Is the incremental
cost small relative
to the net benefits?
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
ICER not available, costs include therapist fees (social worker, behavioural therapist, physician, nurse)
Inequities relate to access to trained therapists, travel and other
out of pocket expenses
incurred by individuals
○ Increased
● Probably inEquity
Acceptability
What would be the
impact on health
inequities?
Is the option acceptable to key
stakeholders?
creased
○ Uncertain
○ Probably reduced
○ Reduced
○ Varies
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
Acceptability of counselling interventions is physician and patient dependent. A cross-sectional survey of Saudi primary care physicians suggests that these physicians self-identify as playing a key role in the management of obesity, but the majority felt unprepared to effectively address this issue. Brief physician training and counselling interventions described in this study, suggests opportunities for further research consideration. Alsahmarri, 2014
Management of Overweight and Obese
Adults
Criteria
30
Judgements
Research evidence
Additional considerations
○ Varies
Feasibility
Is the option feasible to implement?
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
Feasibility depends on
availability of trained
clinicians and acceptability of psychotherapy
approaches. Feasibility is
related to recruiting
trained staff and training
existing staff.
Management of Overweight and Obese
Adults
31
Recommendation
Should psychotherapy vs. no psychotherapy be used for obese and overweight adults?
Balance of consequences
Undesirable consequences clearly outweigh desirable consequences in
most settings
Undesirable consequences probably outweigh
desirable consequences in
most settings
The balance between desirable and undesirable consequences is closely balanced
or uncertain
Desirable consequences
probably outweigh undesirable consequences in
most settings
Desirable consequences
clearly outweigh undesirable consequences in
most settings
○
○
○
●
○
Type of recommendation
We recommend against offering
this option
We suggest not offering
this option
We suggest offering
this option
We recommend offering
this option
○
○
●
○
Recommendation
The panel suggests cognitive behavioral therapy rather than no such therapy in overweight and obese adults.
Justification
Probably large effect and no adverse consequences other than resource use.
Subgroup considerations
Psychotherapy should not be a substitute for psychiatric assessment in all individual with suspected or confirmed eating disorder or depression.
Implementation considerations
Cognitive Behavioural Therapy used in this intervention was described as delivered by a social who worker made use
of guided exercises to emphasize relationships between thoughts and actions, identification of negative or distorted
thoughts and connection with maladaptive eating behaviours/schemas and resources for implementation would include costs of training and fees of specialized health professionals.
Monitoring and evaluation
None
Research possibilities
Systematic review of observational studies done locally in Saudi Arabia in both men and women.
Management of Overweight and Obese
Adults
32
Evidence Profile
Author(s): Ainsley Moore
Date: 2104-12-14
Question: Psychotherapy compared to no psychotherapy for obese and overweight adults
Settings: Community
Bibliography (systematic reviews): Stahre, 2007; Grilo, 2012
Quality assessment
№ of
studies
Study design
Risk of bias
Inconsistency
№ of patients
Indirectness
Imprecision
Other considerations
Effect
psychotherapy
no psychotherapy
Relative
(95% CI)
Absolute
(95% CI)
16
26
-
mean 6.1 lower
(9.53 lower to 2.67
lower)
Quality
Importance
Weight change (follow up: mean 18 months; assessed with: mean kg)
1
randomised
trials
serious
13
not serious
serious
4
serious
2
none
MD – mean difference, RR – relative risk
1.
2.
3.
4.
randomization process not reported, concealment not indicated unable to determine if all outcomes intended to evaluate are reported
wide confidence interval around mean effect
Attrition rates high 22% after randomization prior to treatment
Indirect measure of cardiovascular disease, longevity, not a cognitive-behavioral
⨁⨁◯◯
LOW
CRITICAL
Management of Overweight and Obese
Adults
33
Guideline Question 2: Should intensive lifestyle intervention (diet, exercise and behaviour modification) compared to usual, minimal care
be used for overweight and obese adults?
Population
Intervention
Comparison
Outcomes
General obese population at risk for diabetes (impaired glucose tolerance)
Individualized lifestyle counselling, moderate physical activity (> 30
mins/day), low fat diet. Delivered by multidisciplinary team over 1-6 years
Usual or minimal care (verbal general behavioural information- 4 annual visits)
Abdominal obesity
Physiological parameters (blood pressure, lipids)
Cardiovascular events (acute coronary event, coronary heart disease, stroke,
hypertensive disease)
Mortality
Background:
Background: Lifestyle interventions are the cornerstone of obesity treatment. Intensive lifestyle interventions (ILI) involve more extreme dietary,
physical and behavioural counselling, delivered by multidisciplinary teams of nutritionists, physicians, behavioural therapists and exercise trainers.
10,11
ILI typically involves low to very low calorie diets (< 30-25% of calories from fat), moderate to intense physical activity (> 30 minutes daily or
the equivalent of consuming 1800-2500 Kcals/week), and individualized behavioural goal setting, delivered at weekly or bi monthly visits for 1 to
several years. 10,11 ILI is therefore reserved for populations at high risk of obesity. Outcomes for this intervention are consequently longer-term,
such as mortality and cardiovascular events, which are direct patient important end-points.10,11
Evidence summary:
Evidence for ILI versus usual care comes from the Finish Diabetes Prevention Program, derived from the NHMRC review. 11,12 Certainty of evidence
regarding ILI impact on physiological parameters (blood pressure, lipids) and abdominal obesity is moderate. Prevalence of abdominal obesity at
end of study in the ILI group was 26% (n= 267) compared to usual care 28% (n= 257). Number needed to treat (NNT) to achieve resolution of abdominal obesity over 4 years = 37 (range 26- 10). NNT to achieve resolution of elevated blood pressure, triglycerides and low HDL is 42, 27 and 15
respectively. Evidence of impact on mortality is upgraded to high certainty due to directness of this outcome. There were 10 deaths in the usual
care group versus 6 in the ILI group (NNH = 58). Impact on cardiovascular disease (composite end-point, see outcome description above) is downgraded to low certainty due to imprecision (3 more cardiovascular events in ILI group, OR = 1.02). Other parameters such as weight change or end
of study weight were not reported.
Management of Overweight and Obese
Adults
34
Evidence to Decision Framework: Should intensive lifestyle intervention (diet, exercise and behaviour modification) compared to usual, minimal care be
used for overweight and obese adults?
Criteria
Problem
Benefits &
harms of the
options
Judgements
Is there a problem priority?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
What is the overall
certainty of this evidence?
○ No included studies
○ Very low
● Low
○ Moderate
○ High
○ Important uncertainty or variability
○ Possibly important
uncertainty or variability
Is there important uncertainty about how
Probably no immuch people value the portant uncertainty of
main outcomes?
variability
○
● No important uncertainty of variability
○ No known undesirable
Research evidence
Additional Considerations
Obesity in Saudi Arabia is a growing health concern. Obese and
overweight adults represent over 70% of the population.24 Females are significantly more obese than males with a prevalence of 44%, compared to 26%, while overweight is significantly more prevalent among males (42.4%) compared to females
(31.8%). 25 Obesity and overweight are well known risk factors
for diabetes, coronary artery disease, hypertension, breathing
and sleep disorders, as well as impaired quality of life
The relative importance or values of the main outcomes of interest:
Summary of findings: Intensive lifestyle interventions (diet and exercise) compared to usual or minimal care (general behavioural information) for obese and overweight adults
Patient values and preferences:
Impact of obesity (BMI ≥ 26
mg/kg2) on health-related quality of life (across multiple utility
measures: EQ5D, EuroQol, VAS
and SF6D) suggests significantly more problems with pain,
mobility, role limitations and
social functioning compared to
those who are pre-obese or
overweight.
(Keating et al. 2007)
Management of Overweight and Obese
Adults
Criteria
Judgements
Are the desirable anticipated effects large?
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
Are the undesirable
anticipated effects
small?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Are the desirable effects large relative to
undesirable effects?
Resource use
35
Are the resources required small?
Research evidence
Additional Considerations
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
● No
○ Probably no
○ Uncertain
○ Probably yes
Intensive lifestyle interventions
have resource implications that
are greater than less intensive
interventions. Health professionals fees of occupational
therapists, behavioural specialists, physical trainers and phy-
Management of Overweight and Obese
Adults
Criteria
36
Judgements
Research evidence
Additional Considerations
sicians contribute to direct
medical costs and will vary with
intensity of visits, follow-up and
ongoing monitoring (typical ILI
programme bi-monthly from 1
to several years)
Health professional visit fees
provided by KSA panel below:
General physician: 300 SR
Diabetic Educator: 250SR
Nutritionist: 250 SR
Behavioural Specialist: 400 SR
○ Yes
○ Varies
No ICER available
Is the incremental cost
small relative to the
net benefits?
○ No
● Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
Equity
What would be the
impact on health inequities?
○ Increased
● Probably increased
○ Uncertain
○ Probably reduced
○ Reduced
○ Varies
Out of pocket expense for travel to health facilities,
specilaized diet, trainers, access to multidisciplinary team.
According to KSA panel women
experience greater barriers to
physical activity as they require
accompaniment.
○ No
○ Probably no
○ Uncertain
May not be acceptable to all
patients.
Acceptability
Is the option acceptable to key stakeholders?
Management of Overweight and Obese
Adults
Criteria
37
Judgements
Research evidence
Additional Considerations
● Probably yes
○ Yes
○ Varies
Feasibility
Is the option feasible
to implement?
○ No
○ Probably no
○ Uncertain
○ Probably yes
○ Yes
● Varies
May not be feasible on population level. It might be possible
to implement in selected settings. Barriers include the resources and availability of the
health care workers to support
intensive lifestyle modification.
May be feasible in some centers
where resources are available.
Management of Overweight and Obese
Adults
38
Recommendation
Should intensive lifestyle vs. usual or minimal care be used in obese patients?
Balance of consequences
Type of recommendation
Undesirable consequences clearly outweigh desirable consequences in most settings
Undesirable consequences probably outweigh desirable consequences in most settings
The balance between desirable and undesirable
consequences is closely
balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences
in most settings
Desirable consequences clearly outweigh
undesirable consequences in most settings
○
○
○
●
○
We recommend against offering
this option
We suggest not offering
this option
We suggest offering
this option
We recommend offering
this option
○
○
●
○
Recommendation
The panel suggests using intensive lifestyle modification rather than usual or minimal care in overweight and obese
adults.
Justification
Most panel members thought that the benefit in terms of prevention of diabetes and associated cost of care outweighs the downsides. One panel member thought the balance of desirable and undesirable consequences was uncertain because of concerns about cost effectiveness and feasibility.
Subgroup considerations
Patients at higher risk for diabetes may benefit more from this intervention.
Implementation considerations
Implementation will require well organized, standardized lifestyle intervention programs.
Monitoring and evaluation
None
Research possibilities
Generation of local evidence for lifestyle modification is recommended (The research evidence used in this guideline
involving behaviours may be not applicable for Saudi population which could affect the outcome).
Management of Overweight and Obese
Adults
39
Evidence Profile
Author(s): Ainsley Moore
Question: Intensive lifestyle interventions (diet and exercise) compared to usual or minimal care (general behavioural information) for obese and overweight adults
Setting: Mixed
Bibliography (systematic reviews): As cited in NHRMC Clinical Practice Guidelines for the Management of overweight and obesity in adults, adolescents and children in Australia- Systematic
Review. Melbourne: National Health and Medical research Council (Ilane,-Parikka 2008; Uusitupa 2009, Look AHEAD, 2013 (NEJM 369:145-54)
Quality assessment
№ of
studies
Study design
Risk of
bias
№ of patients
Inconsistency Indirectness
Imprecision
Other considerations
intensive lifestyle
interventions (diet
and exercise)
usual or minimal
care (general behavioural information)
Effect
Quality
Importance
Relative
(95% CI)
Absolute
(95% CI)
OR
0.869
(0.600
to
1.200)
27 fewer per 1000 (from
38 more to 91 fewer) 4
⨁⨁⨁◯
MODERATE
CRITICAL
14 fewer per 1000 (from
47 more to 63 fewer) 4
⨁⨁⨁◯
MODERATE
CRITICAL
Abdominal obesity (>102 cm men, >88 cm women) (follow up: mean 4 years; assessed with: prevalence )
1
randomised
trials
not
serious
1
not serious
serious
2
not serious 3
none
68/265 (25.7%)
72/257 (28.0%)
Low HDL cholesterol (Low HDL cholesterol < 40 mg/dl or < 1.03 mmol/L) (follow up: mean 4 years; assessed with: prevalence of low HDL cholesterol)
1
randomised
trials
not
serious
not serious
serious
2
1
not serious 3
none
43/265 (16.2%)
46/257 (17.9%)
RR 0.92
(0.65 to
1.26)
Elevated Blood Pressure (systolic blood pressure > 130 mmHg, diastolic BP greater than 85 mmHG) (follow up: mean 3 years; assessed with: prevalence of elevated blood pressure)
1
randomised
trials
not
serious
1
not serious
not serious 2
not serious 3
none
73/265 (27.5%)
76/257 (29.6%)
RR 0.92
(0.69 to
1.19)
24 fewer per 1000 (from
56 more to 92 fewer)
⨁⨁⨁⨁
HIGH
CRITICAL
not serious 3
none
408/2827 (14.4%)
428/2818 (15.2%)
RR 0.95
(0.84 to
1.08)
8 fewer per 1000 (from
12 more to 24 fewer)
⨁⨁⨁◯
MODERATE
CRITICAL
Mortality (follow up: mean 10 years; assessed with: events)
2
randomised
trials
serious
1
not serious
not serious
Cardio Vascular Morbidity (acute coronary events, coronary heart disease, stroke and hypertensive disease.) (follow up: mean 10 years; assessed with: events)
Management of Overweight and Obese
Adults
1
randomised
trials
not
serious
1
not serious
40
not serious
very serious 3
none
57/257 (22.2%)
54/248 (21.8%)
OR 1.02
(0.70 to
1.56)
3 more per 1000 (from
55 fewer to 85 more)
⨁⨁◯◯
LOW
not serious
none
99/2472 (4.0%)
119/2395 (5.0%)
RR 0.86
(64.00
to 1.09)
7 fewer per 1000 (from 4
more to 1000 more)
⨁⨁⨁◯
MODERATE
not serious
none
2472
2394
-
mean 4 lower
(5 lower to 3 lower)
⨁⨁◯◯
LOW
CRITICAL
Hospitalization heart failure (follow up: mean 10 years)
1
randomised
trials
serious
1
not serious
not serious
Weight (follow up: mean 9.6 years; assessed with: Kg)
1
randomised
trials
serious
1
not serious
serious
2
CRITICAL
MD – mean difference, RR – relative risk
1.
2.
3.
Blinding not possible
population, outcome indirect
Sample size small, 1 study
References
1. Ilanne-Parikka P, Eriksson JG, Lindström J, et al. Effect of lifestyle intervention on the occurrence of metabolic syndrome and its components in the
Finnish Diabetes Prevention Study. Diabetes Care 2008;31:805-7.
2. Uusitupa M, Peltonen M, Lindström J, et al. Ten-year mortality and cardiovascular morbidity in the Finnish Diabetes Prevention Study—secondary
analysis of the randomized trial. PLoS One 2009;4:e5656.
3. Long Term Effects of a Lifestyle Intervention on Weight and Cardiovascular Risk Factors in Individuals with Type 2 Diabetes: Four Year Results of the
Look AHEAD Trial. Archives of internal medicine 2010;170:1566-75.
Management of Overweight and Obese
Adults
Guideline Question 3: Should lifestyle interventions compared to usual care be used for overweight and obese adults?
Population
Intervention
Comparison
Outcomes
Predominantly women, mean BMI = 28, weight = 81 kg
lifestyle interventions (low to very low calorie diet, walking, resistance training, individual behavioural goals)
Usual care
Weight change
Physiological parameters (systolic and diastolic blood pressure, lipids)
Sleep apnea
Background:
Lifestyle interventions are multi-component treatments that involve promoting healthy lifestyle habits, dietary interventions, dietary counselling,
physical exercise training as well as psychological and behavioural interventions. Pharmacotherapies are often an adjunct to lifestyle interventions,
but are not included in this definition of lifestyle interventions. Lifestyle interventions are the cornerstone of obesity management. 12
Evidence summary:
Evidence for lifestyle interventions is based on the 2013 NHMRC systematic review and the recent Canadian systematic review and meta-analysis
that were identified through our literature update.14
Certainty of pooled evidence overall is moderate for this intervention, downgraded for indirectness of blood pressure, weight and cholesterol as
surrogate measures of cardiovascular disease. Meta-analysis across 5 studies from the NHMRC review, reported systolic blood pressure improvement of 1.95 mmHg ( 1.7), whereas diastolic blood pressure decreased significantly by 3.24 mmHg ( 1.2) (Figure 1). An approximate weight reduction of 4 kg was also reported within 1 year (not pooled due to heterogeneity). Similar weight loss results are reported in the Canadian metaanalysis, where pooled impact on weight across 46 studies (n = 10829), favoured a 3.1 kg (0.75) weight reduction in the lifestyle group compared
to the control group (shorter duration of studies, most < 12 months). LDL cholesterol decreased modestly (0.5 mmol/L 0.15) in the lifestyle group
(no forest plot reported for these results).
41
Management of Overweight and Obese
Adults
Figure 1: Lifestyle vs other therapies – Systolic Blood Pressure, Diastolic Blood Pressure (NHMRC, 2013)
42
Management of Overweight and Obese
Adults
43
Evidence to Decision Framework: Should lifestyle interventions compared to usual care be used for overweight and obese adults?
Criteria
Problem
Is there a problem priority?
Judgements
Research evidence
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Obesity in Saudi Arabia is a growing health concern. Obese and overweight adults represent over 70% of the population.24 Females are significantly more obese than males with a prevalence of 44%, compared to
26%, while overweight is significantly more prevalent among males
(42.4%) compared to females (31.8%). 25 Obesity and overweight are
well known risk factors for diabetes, coronary artery disease, hypertension, breathing and sleep disorders, as well as impaired quality of life
○ No included
The relative importance or values of the main outcomes of interest:
studies
What is the overall certainty of
this evidence?
○ Very low
○ Low
● Moderate
○ High
○ Important
Benefits &
harms of the
options
uncertainty or
variability
Is there important uncertainty about how
much people value the main outcomes?
Outcome
Relative importance
Additional considerations
Certainty of the evidence
(GRADE)
Change in systolic blood
pressure
CRITICAL
⨁⨁⨁◯
Change in diastolic blood
pressure
CRITICAL
⨁⨁⨁◯
Change in weight
CRITICAL
⨁⨁⨁◯
Change in LDL cholesterol
CRITICAL
⨁⨁⨁◯
MODERATE
MODERATE
MODERATE
MODERATE
○ Possibly
important uncertainty or
variability
○ Probably no
important uncertainty of
variability
● No important uncer-
Summary of findings: Lifestyle compared to other interventions for obese and
overweight adults
Patient values and preferences:
Impact of obesity (BMI ≥ 26 mg/kg2)
on health-related quality of life
(across multiple utility measures:
EQ5D, EuroQol, VAS and SF6D) suggests significantly more problems
with pain, mobility, role limitations
and social functioning compared to
those who are pre-obese or overweight.
(Keating et al. 2007)
Management of Overweight and Obese
Adults
Criteria
44
Judgements
tainty of variability
○ No known
Research evidence
Additional considerations
Difference
(95% CI)
With Lifestyle
Change in
systolic
blood pressure
The mean
change in systolic blood pressure in the control group was 0
The mean change in
systolic blood pressure in the intervention group was 1.95
mean change lower
(3.69 higher to 0.21
lower)
mean
change 1.95
lower
(3.69 higher
to 0.21 lower)
Change in
diastolic
blood pressure
The mean
change in diastolic blood pressure in the control group was 4.4 mmHg
The mean change in
diastolic blood pressure in the intervention group was 3.24
mean change lower
(4.47 lower to 2.02
lower)
mean
change 3.24
lower
(4.47 lower
to 2.02 lower)
Change in
weight
The mean
change in
weight in the
control group
was -0.11 kg
The mean change in
weight in the intervention group was
3.13 lower (3.88
lower to 2.38 lower)
mean 3.13
lower
(3.88 lower to 2.38 lower)
Change in
LDL cholesterol
The mean
change in LDL
cholesterol in
the control
group was 0
The mean change in
LDL cholesterol in
the intervention
group was 0.14 lower (0.29 lower to
0.002 lower)
mean 0.14
lower
(0.29 lower
to 0.002
lower)
undesirable
Are the desirable
anticipated effects large?
Are the undesirable anticipated
effects small?
Are the desirable
effects large relative to undesirable effects?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Relative
effect
(RR)
(95% CI)
Without Lifestyle
Outcome
-
Management of Overweight and Obese
Adults
Criteria
Are the resources
required small?
45
Judgements
Research evidence
lifestyle interventions have resource
implications associated with health
professionals fees of occupational
therapists, behavioural specialists,
physical trainers and physicians contribute to direct medical
costs and will vary with intensity of
visits, follow-up and ongoing monitoring.
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Health professional visit fees provided by KSA panel below:
General physician: 300 SR
Diabetic Educator: 250SR
Resource use
Nutritionist: 250 SR
Behavioural Specialist: 400 SR
Is the incremental cost small relative to the net
benefits?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
○ Increased
○ Probably
increased
Equity
Additional considerations
What would be
the impact on
health inequities?
○ Uncertain
○ Probably
reduced
○ Reduced
○ Varies
No ICER available
Management of Overweight and Obese
Adults
Criteria
46
Judgements
● N/A
Acceptability
Feasibility
Is the option acceptable to key
stakeholders?
Is the option feasible to implement?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Research evidence
Additional considerations
Management of Overweight and Obese
Adults
47
Recommendation
Should Lifestyle vs. other interventions be used for obese and overweight adults?
Balance of consequences
Undesirable consequences
clearly outweigh desirable
consequences in most settings
Undesirable consequences
probably outweigh desirable
consequences in most settings
The balance between desirable
and undesirable consequences
is closely balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in most
settings
Desirable consequences
clearly outweigh undesirable
consequences in most settings
○
○
○
○
●
Type of recommendation
Recommendation
We recommend against offering this option
We suggest not offering this
option
We suggest offering this option
We recommend offering this option
○
○
○
●
The panel recommends lifestyle intervention rather than usual care alone in overweight and obese adults.
Justification
Subgroup considerations
None
Implementation considerations
Should be tailored to patient’s comorbidities.
Monitoring and evaluation
None
Research possibilities
Generation of local evidence for lifestyle modification is recommended (The research evidence used in this guideline involving behaviours may
be not applicable for Saudi population which could affect the outcome).
Management of Overweight and Obese
Adults
48
Evidence Profile
Author(s): Ainsley Moore
Date:
Question: Lifestyle compared to usual care be used for obese and overweight adults
Setting: Mixed
Bibliography (systematic reviews): As cited in NHMRC Clinical Practice Guidelines for the Management of overweight and obesity in adults, adolescents and children in Australia- Systematic
1
Review. Melbourne: National Health and Medical research Council (Azadbakht, 2007; Croft, 1986; Fletcher-Mors, 2000; Gordon, 1997; Groeneveld, 1997; Heshka, 2003; Aucott, 1990; Kukko2
nen, 2005; Kuller, 2001; Stefanick, 1998; Wing, 1998), Peirson, 2014
Quality assessment
№ of studies
Study design
Risk of bias
№ of patients
Inconsistency Indirectness Imprecision
Other considerations
Lifestyle
Effect
Quality
Importance
other interventions
Relative
(95% CI)
Absolute
(95% CI)
582
-
mean change 1.95 lower
(3.69 higher to 0.21 lower)
⨁⨁⨁◯
MODERATE
CRITICAL
Change in systolic blood pressure (follow up: mean less than or equal to 1 year; assessed with: Mean change (mmHg))
51
randomised
trials
not serious
not serious
2
not serious
not serious
none
567
Change in diastolic blood pressure (follow up: mean less than or equal to 1 year; assessed with: mean change (mmHg))
51
randomised
trials
not serious
not serious
2
not serious
not serious
none
567
582
-
mean change 3.24 lower
(4.47 lower to 2.02 lower)
⨁⨁⨁◯
MODERATE
CRITICAL
none
4366
6463
-
mean 3.13 lower
(3.88 lower to 2.38 lower)
⨁⨁⨁◯
MODERATE
CRITICAL
none
1878
1678
-
mean 0.14 lower
(0.29 lower to 0.002 lower)
⨁⨁⨁◯
MODERATE
CRITICAL
Change in weight (follow up: range < 12 months; assessed with: mean change (kg))
462
randomised
trials
not serious 3
not serious
2
serious
1
not serious
Change in LDL cholesterol (follow up: range <12 months; assessed with: mmol/L)
152
randomised
trials
not serious
not serious
serious
1
not serious
MD – mean difference, RR – relative risk
1.
2.
3.
no serious indirectness for blood pressure but for a patient important outcome (cardiovascular morbidity and mortality) for which blood pressure is a surrogate
Lifestyle intervention components and delivery vary across studies
High attrition rates in many studies
Management of Overweight and Obese
Adults
49
References
1. Azadbakht L, Mirmiran P, Esmaillzadeh A, Azizi F. Better dietary adherence and weight maintenance achieved by a long-term moderate-fat diet. British journal of
nutrition 2007;97:399-404
2. Croft P, Brigg D, Smith S, et al. How useful is weight reduction in the management of hypertension? J R Coll Gen Pract 1986; 36: 445-448.
3. Fletcher-Mors et al. Metabolic and weight loss effects of long-term dietary interventions in obese patients: four year results. 2000. Obesity Research. 8(5): 399402.
4. Gordon NF et al. Comparison of single versus multiple lifestyle interventions: are the antihypertensive effects of exercise training and diet-induced weight loss additive? American Journal of Cardiology. 79 (6): 763-767.
5. Groeneveld IF, et al. Sustained body weight reduction by an individual-based lifestyle intervention for workers in the construction industry at risk for cardiovascular disease: results of a randomized controlled trial. 1997. Preventive medicine 51(3-4): 240-246.
6. Heshka S, et al. Weight loss with self-help compared with a structured commercial program: a randomized trial. 2003. JAMA 289(14): 1792-1798.
7. Aucott L, et al. Long-Term Weight Loss From Lifestyle Intervention Benefits Blood Pressure? A Systematic Review. 2009 Hypertension 54: 756-762.
8. Kukkonen-Harjula KT, Borg PT, Nenonen AM, Fogelholm MG. Effects of a weight maintenance program with or without exercise on the metabolic syndrome: a
randomized trial in obese men. Prev Med. 2005; 41: 784 –790.
9. Kuller LH, Simkin-Silverman LR, Wing RR, Meilahn EN, Ives DG. Women’s Healthy Lifestyle Project: A randomized clinical trial: results at 54 months. Circulation.
2001;103:32–37.
10. Stefanick et al. Effects of diet and exercise in men and postmenopausal women with low levels of HDL cholesterol and high levels of LDL cholesterol.
1998. N Engl Med 339 (1): 12-20.
11. Wing et al. Lifestyle intervention in overweight individuals with a family history of diabetes. 1998. Diabetes Care 21 (3): 350-359.
12. Peirson L, Douketis J, Ciliska D, Fitzpatrick-Lewis D, Ali MU, Raina P. Treatment for overweight and obesity in adult populations: a systematic review and metaanalysis. Canadian Medical Association Open Access Journal 2014;2:E306-E17.
Management of Overweight and Obese
Adults
50
Guideline Question 4: Should nutrition and physical activity counselling compared to health education pamphlets be used for overweight
and obese adults?
Population
Intervention
Comparison
Outcomes
Diabetics, BMI > 25, Hispanic or Latino receiving Medicaid
Computer generated tailored self-management goals for nutrition and
physical activity, reviewed every 3 months with usual diabetic care
Written generic health education materials provided once at baseline
visit addressing diabetes, diet, and exercise, f/u q 3 months with MD
for usual diabetic care x 12 months
Weight change
Waist circumference change
Engagement in physical activity
Physiological parameters (blood pressure, lipids)
Background:
This brief intervention focuses on nutrition and physical activity counselling, the core components of lifestyle interventions, which are the cornerstone of obesity management. Distinct from other lifestyle approaches, this brief and simple intervention is intended to be delivered by primary
care physicians within constraints of limited office time and limited behavioural counselling skills. The emphasis on brevity, and less intensive behavioural/ psychotherapeutic aspects may favours tolerability for both patients and practitioners as evidenced by the lower dropout rate (13%)
compared to traditional lifestyle interventions (> 20%). 15
Evidence summary:
Evidence for this intervention, comes from one moderate sized study (n= 273). 15 Impact on weight loss, physical activity and waist circumference
are indirect measures of cardiovascular health and imprecision is high in this single study, therefore certainty of evidence is downgraded to low.
107 more per thousand lifestyle participants lost more than 5% of their body weight (NNT = 9, range 4 to 71), waist circumference decreased by
1.2 cm (1.6) and the proportion of participants engaged in moderate physical activity (150 or more minutes of physical activity or exercise per
week at a moderate level of intensity) increased by 161 more per 1000 (NNT = 6.2, range 25 to 4). Systolic blood pressure paradoxically, but insignificantly increased by 2.11 mmHg (3.9), diastolic blood pressure decreased by 0.1 mmHg (2.6) and total cholesterol decreased by 3.9 mg/dL
(9.8). This study was derived from the NHMRC review,3 no additional studies directly comparable were identified in our literature update.
Management of Overweight and Obese
Adults
51
Evidence to Decision Framework: Should nutrition and physical activity counselling compared to health education pamphlets be used for overweight and
obese adults?
Criteria
Problem
Judgements
Additional considerations
Research evidence
Is there a problem priority?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Obesity in Saudi Arabia is a growing health concern. Obese and overweight
adults represent over 70% of the population.24 Females are significantly more
obese than males with a prevalence of 44%, compared to 26%, while overweight is significantly more prevalent among males (42.4%) compared to females (31.8%). 25 Obesity and overweight are well known risk factors for diabetes, coronary artery disease, hypertension, breathing and sleep disorders,
as well as impaired quality of life
The relative importance or values of the main outcomes of interest:
What is the overall certainty of
this evidence?
○ No included studies
○ Very low
● Low
○ Moderate
○ High
○ Important uncer-
Benefits &
harms of
the options
tainty or variability
Outcome
Relative importance
Lost > 5% body weight
CRITICAL
⨁⨁◯◯
Engaged in moderate physical
activity
CRITICAL
⨁⨁◯◯
Change in waist circumference CRITICAL
⨁⨁◯◯
○ Possibly important
Is there important
uncertainty about
how much people
value the main
outcomes?
uncertainty or variability
○ Probably no imcertainty of variability
○ No known undesir-
LOW
LOW
LOW
Summary of findings: health education pamphlets
Outcome
portant uncertainty of
variability
● No important un-
Certainty of the evidence (GRADE)
Lost > 5% body
weight
Without nutrition
and physical activity counselling
106 per 1000
With nutrition
and physical activity counselling
213 per 1000
(120 to 350)
Difference
(95% CI)
107 more
per 1000
(from 14
more to 244
Relative
effect
(RR)
(95% CI)
OR 2.28
(1.15 to
4.53)
Patient values, preferences:
Impact of obesity (BMI
≥ 26 mg/kg2) on
health-related quality
of life (across multiple
utility measures:
EQ5D, EuroQol, VAS
and SF6D) suggests
significantly more
problems with pain,
mobility, role limitations and social functioning compared to
those who are preobese or overweight.
(Sach et al. 2007)
Management of Overweight and Obese
Adults
52
Criteria
Judgements
able
Are the desirable
anticipated effects large?
Resource
use
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Are the undesirable anticipated
effects small?
● No
○ Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
Are the desirable
effects large relative to undesirable effects?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Are the resources
required small?
○ No
● Probably no
○ Uncertain
Additional considerations
Research evidence
more)
Engaged in moderate physical
activity
371 per 1000
Change in waist
circumference
The mean change
in waist circumference in the
control group
was -0.54 cm
533 per 1000
(411 to 648)
161 more
per 1000
(from 39
more to 277
more)
OR 1.93
(1.18 to
3.12)
The mean change
in waist circumference in the
intervention
group was 1.2
lower (2.82 higher to 0.39 lower)
mean 1.2
lower
(2.82 higher
to 0.39 lower)
-
Physician time to discuss tailored information and preparation of individualized
information
Management of Overweight and Obese
Adults
Criteria
53
Judgements
Research evidence
○ Probably yes
○ Yes
○ Varies
Equity
Is the incremental
cost small relative
to the net benefits?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
What would be
the impact on
health inequities?
○ Increased
○ Probably increased
○ Uncertain
○ Probably reduced
○ Reduced
○ Varies
● N/A
Is the option acAcceptability ceptable to key
stakeholders?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
Additional considerations
Direct medical costs
are associated with
physician training and
fees, (300-400 SR) x
quarterly visits.
No ICER available
The panel thought that
there would be no
effect on health inequities.
Acceptability of counselling interventions is physician and patient dependent. A crosssectional survey of Saudi primary care physicians suggests that these physicians selfidentify as playing a key role in the management of obesity, but the majority felt unprepared to effectively address this issue, Alsahmarri, 2014
Management of Overweight and Obese
Adults
Criteria
54
Judgements
○ Varies
Feasibility
Is the option feasible to implement?
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
Research evidence
Additional considerations
Management of Overweight and Obese
Adults
55
Recommendation
Should nutrition and physical activity counselling vs. health education pamphlets be used for obese and overweight adults?
Balance of consequences
Undesirable consequences clearly outweigh desirable consequences in
most settings
Undesirable consequences
probably outweigh desirable
consequences in most settings
The balance between desirable
and undesirable consequences is
closely balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in most
settings
Desirable consequences clearly outweigh
undesirable consequences in most settings
○
○
○
○
●
Type of recommendation
We recommend against offering this
option
We suggest not offering this option
We suggest offering this option
We recommend offering this
option
○
○
○
●
Recommendation
The panel recommends individualized counseling interventions rather than generic pamphlets in overweight or obese adults.
Justification
There is health benefit, no downsides other than cost of implementing and there is no doubt among members that individualized approach
in overweight and obese individuals is better.
Subgroup considerations
None
Implementation
considerations
None
Monitoring and evaluation
None
Research possibilities
More research about the methods of individualized interventions.
Management of Overweight and Obese
Adults
56
Evidence Profile
Author(s): Ainsley Moore
Date: Jan 9, 2015
Question: Nutrition and physical activity counseling compared to health education pamphlets for obese and overweight adults
Settings: Mixed
Bibliography (systematic reviews): Christian, 2008
Quality assessment
№ of
studies
Study design
Risk of bias
Inconsistency
№ of patients
Indirectness
Imprecision
Effect
Other considerations
nutrition and
physical activity
counselling
health education pamphlets
Relative
(95% CI)
Absolute
(95% CI)
none
30/141 (21.3%)
14/132 (10.6%)
OR 2.28
(1.15 to 4.53)
107 more per
1000 (from 14
more to 244
more)
⨁⨁◯◯
LOW
CRITICAL
Quality
Importance
Lost >5% body weight (follow up: mean 12 months; assessed with: prevalence)
1
randomised
trials
not serious 1
not serious
serious
4
serious
2
Engaged in moderate physical activity (follow up: mean 12 months; assessed with: % subjects achieved)
1
randomised
trials
not serious 1
not serious
serious
4
serious
2
none
75/141 (53.2%)
49/132 (37.1%)
OR 1.93
(1.18 to 3.12)
161 more per
1000 (from 39
more to 277
more)
⨁⨁◯◯
LOW
CRITICAL
2
none
141
132
-
mean 1.2 lower
(2.82 higher to
0.39 lower)
⨁⨁◯◯
LOW
CRITICAL
141
132
-
mean 2.11
higher
(6.07 higher to
2.79 lower)
⨁⨁◯◯
LOW
CRITICAL
Change in waist circumference (follow up: mean 12 months; assessed with: cm )
1
randomised
trials
not serious 1
not serious
serious
4
serious
Change in systolic blood pressure (follow up: mean 12 months; assessed with: mean mmHg)
1
randomised
trials
not serious
not serious
serious
4
serious
2
Change in diastolic blood pressure (follow up: mean 12 months; assessed with: mmHg)
none
Management of Overweight and Obese
Adults
1
randomised
trials
not serious
not serious
57
serious
3
serious
2
none
141
132
-
mean 0.1 lower
(2.95 lower to
2.75 higher)
⨁⨁◯◯
LOW
CRITICAL
2
none
141
132
-
mean 3.9 lower
(5.96 higher to
13.75 lower)
⨁⨁◯◯
LOW
CRITICAL
Change in total cholesterol (follow up: mean 12 months; assessed with: mg/dL)
1
randomised
trials
not serious
not serious
serious
3
serious
MD – mean difference, RR – relative risk
1.
2.
3.
4.
Blinding not possible to participants
Small single study wide CI
Blinding participants and assessors not possible
Indirect measure of cardiovascular morbidity
References
1. Christian JG, Bessesen DH, Byers TE, Christian KK, Goldstein MG, Bock BC. Clinic-based support to help overweight patients with type 2 diabetes increase physical activity
and lose weight. Archives of Internal Medicine 2008;168:141-6.
Management of Overweight and Obese
Adults
Guideline Question 5: Should isocaloric low fat diet compared to moderate fat diet be used for overweight and obese adults?
Population
Diabetic obese, general obese and overweight adults
Intervention
Dietary advice to achieve 20-30% of calories from fat or the equivalent
fat distribution in meals was provided
Comparison
30-36% of calories from fat. One study provided meals to achieve same
fat-calorie distribution
Weight change
Physiological parameters: systolic and diastolic blood pressure , lipids
Outcomes
Background:
People with diabetes are advised to reduce fat intake in order to decrease their risk of cardiovascular disease. There is debate about the feasibility
of adherence to and benefits of very low fat diets for improving cardiovascular risk and achieving weight loss. One trial conducted in Iran that was
reported in the NHMRC review found significant reduction (P<0.001) in waist circumference of 5.5 cm (SD 2.4) in the moderate fat versus low fat
group. 13 The authors conclude that better adherence to the more appetizing moderate fat diet was the reason for success, which would have relevance regarding this option for the Saudi context. 16
Evidence summary:
Three studies 16,17,18 , informing this intervention are derived from the NHMRC review. Meta-analysis was not undertaken in the original review but
is provided here for effect on weight and lipids (Figure 2). There is low certainty of evidence for this obesity management option, due to indirectness of weight and physiological parameters as measures of cardiovascular disease, as well as differences across interventions and comparators
(some studies provided meals, others provided dietary advice to achieve the same fat distribution of meals) which contributes systematic error
and high levels of heterogeneity for total cholesterol and triglyceride outcomes, 93% and 90% respectively). Minimal improvement in weight
(0.8kg 1.2), systolic blood pressure (2.8mmHg 8.6), diastolic blood pressure (2.8mmHg4.4), total cholesterol
(-0.21mmol/L 0.09) and HDL cholesterol (0.12 0.16) were observed, while triglycerides increased (0.53  0.12). Although there is intervention
variability across studies, heterogeneity is low (I2 = 14%, P=0.20).
58
Management of Overweight and Obese
Adults
Figure 2: Low vs. moderate fat diet
Weight
HDL Cholesterol
Total Cholesterol
59
Management of Overweight and Obese
Adults
Triglycerides
60
Management of Overweight and Obese
Adults
61
Evidence to Decision Framework: Should isocaloric low fat compared to moderate fat be used on obese and overweight adults?
Criteria
Problem
Judgements
Additional considerations
Research evidence
Is there a problem
priority?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Obesity in Saudi Arabia is a growing health concern. Obese and overweight adults represent over 70% of the population.1 Females are significantly more obese than males with a prevalence of 44%, compared
to 26%, while overweight is significantly more prevalent among males
(42.4%) compared to females (31.8%). 1 Obesity and overweight are
well known risk factors for diabetes, coronary artery disease, hypertension, breathing and sleep disorders, as well as impaired quality of life
The relative importance or values of the main outcomes of interest:
What is the overall
certainty of this
evidence?
○ No included studies
○ Very low
● Low
○ Moderate
○ High
○ Important uncertainty or
Benefits &
harms of
the options
Outcome
Relative importance
Weight
CRITICAL
⨁⨁◯◯
LOW
Total cholesterol
CRITICAL
⨁⨁◯◯
LOW
HDL cholesterol
CRITICAL
⨁⨁◯◯
LOW
Triglycerides
CRITICAL
⨁⨁◯◯
LOW
Systolic blood pressure
CRITICAL
⨁⨁◯◯
LOW
Diastolic blood pressure
CRITICAL
⨁⨁⨁◯
MODERATE
variability
Is there important
uncertainty about
how much people
value the main outcomes?
○ Possibly important uncertainty or variability
○ Probably no important
uncertainty of variability
● No important uncertainty
of variability
○ No known undesirable
Certainty of the evidence (GRADE)
Patient values, preferences:
Impact of obesity
(BMI ≥ 26 mg/kg2)
on health-related
quality of life (across
multiple utility
measures: EQ5D,
EuroQol, VAS and
SF6D) suggests significantly more problems with pain, mobility, role limitations
and social functioning compared to
those who are preobese or overweight.
(Keating et al. 2007)
Management of Overweight and Obese
Adults
Criteria
Are the desirable
anticipated effects
large?
Are the undesirable
anticipated effects
small?
Are the desirable
effects large relative to undesirable
effects?
62
Judgements
● No
○ Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
○ No
○ Probably no
● Uncertain
○ Probably yes
○ Yes
○ Varies
○ No
○ Probably no
● Uncertain
○ Probably yes
○ Yes
○ Varies
Additional considerations
Research evidence
Summary of findings: moderate fat diet
Relative
effect
(RR)
(95% CI)
With low fat
diet
Difference
(95% CI)
Weight
The mean
weight in the
control group
was 77.8 kg
The mean
weight in the
intervention
group was
0.79 lower
(1.99 lower to
0.41 higher)
mean 0.79
lower
(1.99 lower
to 0.41 higher)
-
Total cholesterol
The mean
total cholesterol in the
control group
was 5.6
mmol/l
The mean
total cholesterol in the
intervention
group was
0.21 lower
(8.86 lower to
8.44 higher)
mean 0.21
lower
(8.86 lower
to 8.44 higher)
-
HDL cholesterol
The mean HDL
cholesterol in
the control
group was
1.14 mmol/l
The mean HDL
cholesterol in
the intervention group was
0.03 lower
(0.62 lower to
0.56 higher)
mean 0.03
lower
(0.62 lower
to 0.56 higher)
-
Triglycerides
The mean
triglycerides in
the control
group was
2.92 mmol/l
The mean
triglycerides in
the intervention group was
0.2 higher
(0.05 lower to
mean 0.2
higher
(0.05 lower
to 0.45 higher)
-
Outcome
Without low
fat diet
Management of Overweight and Obese
Adults
Criteria
63
Judgements
Additional considerations
Research evidence
0.45 higher)
Are the resources
required small?
○ No
○ Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
● N/A
Is the incremental
cost small relative
to the net benefits?
○ No
○ Probably no
Resource
use
Systolic blood
pressure
The mean
systolic blood
pressure in
the control
group was
128.9 mmHg
The mean
systolic blood
pressure in
the intervention group was
2.8 lower
(11.4 lower to
5.8 higher)
mean 2.8
lower
(11.4 lower
to 5.8 higher)
-
Diastolic blood
pressure
The mean
diastolic blood
pressure in
the control
group was
82.8 mmHg
The mean
diastolic blood
pressure in
the intervention group was
4.7 lower (9.1
lower to 0.2
higher)
mean 4.7
lower
(9.1 lower to
0.2 higher)
-
Costs associated
with health professional to monitor
use may be a GP,
dietitian or specialist nurse, depending on access to
the type of provider
No ICER available
Management of Overweight and Obese
Adults
Criteria
64
Judgements
○ Uncertain
○ Probably yes
○ Yes
○ Varies
● N/A
Equity
What would be the
impact on health
inequities?
Is the option acAcceptability ceptable to key
stakeholders?
○ Increased
○ Probably increased
○ Uncertain
○ Probably reduced
○ Reduced
○ Varies
● N/A
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Research evidence
Additional considerations
Management of Overweight and Obese
Adults
Criteria
Feasibility
Is the option feasible to implement?
65
Judgements
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Research evidence
Additional considerations
Management of Overweight and Obese
Adults
66
Recommendation
Should isocaloric low fat diet vs. moderate fat diet be used for obese and overweight adults?
Balance of consequences
Type of recommendation
Undesirable consequences
clearly outweigh desirable
consequences in most settings
Undesirable consequences
probably outweigh desirable consequences in most
settings
The balance between desirable and undesirable
consequences is closely
balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in
most settings
Desirable consequences
clearly outweigh undesirable consequences in most
settings
○
○
●
○
○
We recommend against offering this
option
We suggest not offering this
option
We suggest offering this
option
We recommend offering this option
○
○
○
○
Recommendation
The panel makes no recommendation.
Justification
Panel members felt there is not enough evidence to choose one option over another. If any diet is used, fat content should be according to
acceptable macronutrient distribution range (AMDR).
Subgroup considerations
None
Implementation considerations
None
Monitoring and evaluation
None
Research possibilities
The panel suggests randomized controlled trials be done with adequate follow-up duration that compare iso-caloric diets with fat content
lower than 20%, approximately 20% and approximately 30% .
(Conditional recommendation based on low quality evidence)
Management of Overweight and Obese
Adults
67
Evidence Profile
Author(s): Ainsley Moore
Date: Jan 9, 2015
Question: Isocaloric Low fat compared to moderate fat diet for obese and overweight adults
Settings: Mixed
Bibliography (systematic reviews): Azadbakht, 2007; Milne, 1994; Tsihlias, 2000
Quality assessment
№ of studies
Study design
Risk of bias
Inconsistency
№ of patients
Indirectness
Imprecision
Other considerations
serious
Effect
Quality
Importance
low fat
diet
moderate
fat diet
Relative
(95% CI)
Absolute
(95% CI)
none
81
78
-
mean 0.79 lower
(1.99 lower to 0.41 higher)
⨁⨁◯◯
LOW
CRITICAL
serious
none
82
77
-
mean 0.21 lower
(8.86 lower to 8.44 higher)
⨁⨁◯◯
LOW
CRITICAL
serious
none
81
76
-
mean 0.03 lower
(0.62 lower to 0.56 higher)
⨁⨁◯◯
LOW
CRITICAL
serious
none
81
76
-
mean 0.2 higher
(0.05 lower to 0.45 higher)
⨁⨁◯◯
LOW
CRITICAL
none
44
45
-
mean 2.8 lower
(11.4 lower to 5.8 higher)
⨁⨁◯◯
LOW
CRITICAL
none
44
45
-
mean 4.7 lower
(9.1 lower to 0.2 higher)
⨁⨁◯◯
LOW
CRITICAL
Weight (follow up: mean 6-7 months; assessed with: mean change kg)
3
randomised
trials
not serious 1 2
not serious
serious
3
Total cholesterol (follow up: mean 6-18 months; assessed with: mean change (mmol/L))
3
randomised
trials
not serious 1 2
not serious
serious
3
HDL cholesterol (follow up: mean 6-18 months; assessed with: mean change (mmol/L))
3
randomised
trials
not serious 1 2
not serious
serious
3
Triglycerides (follow up: range 6-18 months; assessed with: mean change (mmol/L))
3
randomised
trials
not serious 1 2
not serious
serious
3
Systolic blood pressure (follow up: mean 14 months; assessed with: mean mmHg)
1
randomised
trials
not serious 1 2
not serious
serious
3
serious
4
Diastolic blood pressure (follow up: mean 14 months; assessed with: mean mmHg)
1
randomised
trials
not serious 1 2
not serious
serious
3
serious
Management of Overweight and Obese
Adults
68
MD – mean difference, RR – relative risk
1.
2.
3.
4.
allocation concealment not reported
blinding not reported (participants or assessors) although impact on objective measures (wt, lipids, BP) not considered serious
Outcome indirect
Confidence intervals wide, may change clinical decisions
References
1. Azadbakht L, Mirmiran P, Esmaillzadeh A, Azizi F. Better dietary adherence and weight maintenance achieved by a long-term moderate-fat diet. British journal of
nutrition 2007;97:399-404.
2. Milne RM, Mann JI, Chisholm AW, Williams SM. Long-term comparison of three dietary prescriptions in the treatment of NIDDM. Diabetes Care 1994;17:74-80.
3. Tsihlias EB, Gibbs AL, McBurney MI, Wolever TM. Comparison of high-and low-glycemic-index breakfast cereals with monounsaturated fat in the long-term dietary
management of type 2 diabetes. The American journal of clinical nutrition 2000.72:439-49.
Management of Overweight and Obese
Adults
Guideline Question 6: Should physical activity compared to no physical activity be used in obese and overweight adults?
Population
Intervention
Comparison
Outcomes
General population of obese and overweight adults
Physical activity (walking, jogging, cycling, weight training of high and
moderate intensity)
no exercise
Weight change
Physiological parameters: systolic and diastolic blood pressure, cholesterol
Bone mineral Density (BMD)
Knee pain
Background:
Reduced energy diets and increased energy expenditure through physical activity are the main components of lifestyle interventions, which is first
line treatment of choice for obesity management. 31-33 This question addresses the impact of exercise and diet as an intervention compared to diet
alone as a control, which isolates the impact of exercise. Although evidence supporting the effectiveness of exercise alone on weight loss is disappointing, studies do support exercise effectiveness for preventing weight gain and incidence of diabetes. Additional potential benefits include; improved mobility, physical function (strength), decreased joint pain (associated with arthritis), decreased cardiovascular risk and improved bone
density. 34,35
Evidence summary:
Studies informing this intervention are derived from the NHMRC review and include 2 Cochrane reviews and two more recent RCTs within the
NHMRC review. Effect of exercise compared to no active exercise intervention on weight loss is based on the Cochrane review by Shaw (2006),
which pooled results of weight reduction across 2 studies (n= 270) (Figure 3). 19 Certainty of the estimate for weight loss is moderate (2 kg  0.7),
due to risk of bias associated with unclear randomization and allocation concealment processes, and indirectness of weight as a measure of cardiovascular status. Incidence of diabetes, is based on another Cochrane review (Orozco, 2008) 36 focusing on diabetic populations. Incidence of end
of study diabetes is pooled across 2 studies (n= 351) and this meta-analysis found diabetes incidence decreased by 100 fewer per 1000 individuals
(NNT = 10, range 4 to increasing incidence of diabetes by 193 more per 1000) (Figure 4). 20 One more recent RCT on older obese adults did not
find improvement in gait speed (0.009 m/s) or waist circumference (0.1 cm increase  1.25) in the exercise group, however precautions with interpretation are required due to very low evidence certainty associated with serious risk of bias due to unclear randomization and allocation concealment processes, indirectness of outcomes as measures of mobility/frailty and cardiovascular health as well as imprecision around effect estimates). 21 One high quality study of pre-menopausal women (n= 138), downgraded to moderate for indirectness of outcomes, found bench press
capacity increased significantly (6.6 kg 1.5) and percent change in body fat decreased modestly (1.6% 1.6) in the exercise group. 22
69
Management of Overweight and Obese
Adults
Figure 3: Exercise vs no exercise (Shaw, 2006)
Weight
Figure 4: Exercise vs no exercise (Orozco, 2008)
Incidence of Diabetes
70
Management of Overweight and Obese
Adults
71
Evidence to Decision Framework: Should exercise compared to no active exercise intervention be use in obese and overweight adults?
Criteria
Problem
Is there a problem priority?
Judgements
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
○ No included studies
What is the
○ Very low
overall certainty
● Low
of this evidence?
○ Moderate
○ High
Benefits &
harms of the
options
Is there important uncertainty about
how much people value the
main outcomes?
Are the desirable anticipated
effects large?
○ Important uncertainty or variability
○ Possibly important
uncertainty or variability
○ Probably no important uncertainty
of variability
● No important uncertainty of variability
○ No known undesirable
○
●
○
○
○
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
Additional considerations
Research evidence
Obesity in Saudi Arabia is a growing health concern. Obese and overweight
adults represent over 70% of the population.24 Females are significantly
more obese than males with a prevalence of 44%, compared to 26%, while
overweight is significantly more prevalent among males (42.4%) compared
to females (31.8%). 25 Obesity and overweight are well known risk factors for
diabetes, coronary artery disease, hypertension, breathing and sleep disorders, as well as impaired quality of life
The relative importance or values of the main outcomes of interest:
Outcome
Relative importance
Certainty of the evidence (GRADE)
Incidence of diabetes*
CRITICAL
⨁⨁◯◯
LOW
Waist circumference end of
study*
CRITICAL
⨁⨁◯◯
LOW
Change 400 m/sec Gait
Speed*
CRITICAL
⨁◯◯◯
VERY LOW
Change in % body fat*
CRITICAL
⨁⨁◯◯
LOW
Change in bench press capacity*
CRITICAL
⨁⨁◯◯
LOW
Summary of findings: no exercise
Outcome
Incidence of
Without exercise
526 per 1000
With exercise
426 per 1000
Difference
(95% CI)
Relative
effect
(RR)
(95% CI)
100 fewer per OR 0.67
Patient values, preferences:
Impact of obesity (BMI
≥ 26 mg/kg2) on
health-related quality
of life (across multiple
utility measures:
EQ5D, EuroQol, VAS
and SF6D) suggests
significantly more
problems with pain,
mobility, role limitations and social functioning compared to
those who are preobese or overweight.
(Keating et al. 2007)
Management of Overweight and Obese
Adults
72
Criteria
Are the undesirable anticipated
effects small?
Are the desirable effects large
relative to undesirable effects?
Resource use
Judgements
○
○
○
○
●
○
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
No
Probably no
Uncertain
Probably yes
Yes
Varies
○ No
Are the resources required ○ Probably no
Additional considerations
Research evidence
diabetes
(243 to 635)
1000 (from
109 more to
283 fewer)
(0.29 to
1.57)
Waist circumference end of
study
The mean waist
circumference
end of study in
the control
group was
111.5 cm
The mean waist
circumference
end of study in
the intervention
group was 0.1
higher (1.35
higher to 1.34
lower)
mean 0.1
higher
(1.35 higher
to 1.34 lower)
-
Change 400
m/sec Gait
Speed
The mean
change 400
m/sec Gait
Speed in the
control group
was 0
The mean
change 400
m/sec Gait
Speed in the
intervention
group was 0.009
higher (0 higher
to 0 higher)
mean 0.009
higher
(0 higher to 0
higher)
-
Change in %
body fat
The mean
change in %
body fat in the
control group
was 2.8 %
The mean
change in %
body fat in the
intervention
group was 1.61
lower (3.27 lower to 0.5 lower)
mean 1.61
lower
(3.27 lower
to 0.5 lower)
-
Change in bench
press capacity
The mean
change in bench
press capacity in
the control
group was -2.7
kg
The mean
change in bench
press capacity in
the intervention
group was 6.6
higher (8.29
higher to 4.91
higher)
mean 6.6
higher
(8.29 higher
to 4.91 higher)
-
Health professional
visit fees provided by
Management of Overweight and Obese
Adults
73
Criteria
Judgements
○
○
●
○
Uncertain
Probably yes
Yes
Varies
Is the incremental cost small
relative to the
net benefits?
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
Equity
What would be
the impact on
health inequities?
○
○
○
○
○
○
Increased
Probably increased
Uncertain
Probably reduced
Reduced
Varies
Acceptability
Is the option
acceptable to
key stakeholders?
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
Is the option
feasible to implement?
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
small?
Feasibility
Research evidence
Additional considerations
KSA panel below:
General physician: 300
SR
No ICER available
NOT APPLICABLE
Management of Overweight and Obese
Adults
74
Recommendation
Should physical activity vs no physical activity be used for obese and overweight adults?
Balance of
consequences
Undesirable consequences
clearly outweigh desirable
consequences in most settings
Undesirable consequences
probably outweigh desirable
consequences in most settings
The balance between desirable
and undesirable consequences
is closely balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in most
settings
Desirable consequences
clearly outweigh undesirable
consequences in most settings
○
○
○
○
●
Type of recommendation
Recommendation
We recommend against offering this
option
We suggest not offering this
option
We suggest offering this
option
We recommend offering this option
○
○
○
●
The panel recommends physical activity rather than no physical activity in overweight and obese adults. The main recommendation is combined for this question with Q7 (Diet and exercise compared to diet alone).
Justification
Subgroup considerations
None
Implementation considerations
None
Monitoring and evaluation
None
Research possibilities
None
Management of Overweight and Obese
Adults
75
Evidence Profile
Author(s): Ainsley Moore
Date: Jan 9, 2015
Question: Physical activity compared to no physical activity for obese and overweight adults
Settings: Mixed
Bibliography (systematic reviews): Franz, 2007; Huisman, 2009; Manini, 2010; Schmitz, 2007; Shaw, 2006; Thomas, 2006
Quality assessment
№ of
studies
Study design
Risk of bias
Inconsistency
№ of patients
Indirectness
Imprecision
Other considerations
Effect
Quality
Importance
exercise
no exercise
Relative
(95% CI)
Absolute
(95% CI)
none
63/178
(35.4%)
91/173
(52.6%)
OR 0.67
(0.29 to
1.57)
100 fewer per 1000
(from 109 more to
283 fewer)
⨁⨁◯◯
LOW
CRITICAL
none
102
77
-
mean 0.1 higher
(1.35 higher to 1.34
lower)
⨁⨁◯◯
LOW
CRITICAL
none
102
77
-
mean 0.009 higher
(0 higher to 0 higher)
⨁◯◯◯
VERY LOW
CRITICAL
none
70
63
-
mean 1.61 lower
(3.27 lower to 0.5
lower)
⨁⨁◯◯
LOW
CRITICAL
none
70
63
-
mean 6.6 higher
(8.29 higher to 4.91
higher)
⨁⨁◯◯
LOW
CRITICAL
Incidence of diabetes (follow up: range 2-6 years; assessed with: prevalence end of study)
2
randomised
trials
very serious 1 2 3
not serious
not serious
not serious
Waist circumference end of study (follow up: mean 12 months; assessed with: mean cm)
1
randomised
trials
serious
12
not serious
serious
not serious
Change 400 m/sec Gait Speed (follow up: mean 12 months; assessed with: mean m/sec)
1
randomised
trials
serious
12
not serious
serious
5
serious
4
Change in % body fat (follow up: mean 2 years; assessed with: mean %)
1
randomised
trials
not serious
not serious
serious
6
serious
Change in bench press capacity (follow up: mean 2 years; assessed with: mean kg)
1
randomised
trials
not serious
not serious
serious
5
Change in weight (follow up: range 2-6 years; assessed with: mean kg)
serious
Management of Overweight and Obese
Adults
2
randomised
trials
not serious
2
76
not serious
serious
6
not serious
none
137
133
-
mean 2.03 lower
(1.23 lower to 2.82
lower)
⨁⨁⨁◯
MODERATE
MD – mean difference, RR – relative risk
1.
2.
3.
4.
5.
6.
Randomization process unclear
Allocation concealment unclear
Selective outcome reporting
Single small study wide CI
Outcome indirect measure for mobility/frailty
Outcome indirect measure for cardiovascular health
References
1. Franz, M., J. Van Wormer, et al. (2007) "Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year followup (Provisional abstract)." Journal of the American Dietetic Association 107(10): 1755-1767.
2. Huisman, S., V. De Gucht, et al. (2009). "The effect of weight reduction interventions for persons with type 2 diabetes: a meta-analysis from a self-regulation perspective." Diabetes Educ 35(5): 818-835.
3. Manini, T., A. Newman, et al. (2010). "Effects of exercise on mobility in obese and nonobese older adults." Obesity (Silver Spring) 18(6): 1168-1175.
4. Schmitz, K., P. Hannan, et al. (2007). "Strength training and adiposity in premenopausal women: strong, healthy, and empowered study." Am J Clin Nutr 86(3):
566-572.
5. Shaw, K., H. Gennat, et al. (2006) "Exercise for overweight or obesity." Cochrane Database of Systematic Reviews DOI: 10.1002/14651858.CD003817.pub3.
6. Thomas, D., E. Elliott, et al. (2006) "Exercise for type 2 diabetes mellitus." Cochrane Database of Systematic Reviews DOI: 10.1002/14651858.CD002968.pub2.
Management of Overweight and Obese
Adults
Guideline Question 7: Should diet and physical activity compared to diet alone be used for obese and overweight adults?
Population
Intervention
Comparison
Outcomes
General population of obese and overweight adults
Physical activity (walking, jogging, cycling, weight training of high and
moderate intensity)
Diet (low calorie or low fat)
Diet (low calorie or low fat)
Weight change
Physiological parameters: systolic and diastolic blood pressure, cholesterol
Bone mineral Density (BMD)
Knee pain
Background:
Reduced energy diets and increased energy expenditure through physical activity are the main components of lifestyle interventions, which is first
line treatment of choice for obesity management.31-33 This question addresses the impact of exercise and diet as an intervention compared to diet
alone as a control, which isolates the impact of exercise. Although evidence supporting the effectiveness of exercise on weight loss is disappointing, studies do support exercise effectiveness for preventing weight gain and incidence of diabetes. Additional potential benefits include; improved mobility, physical function (strength), decreased joint pain (associated with arthritis), decreased cardiovascular risk and improved bone
density. 19,34,35
Evidence summary:
All studies informing this intervention derive from the NHMRC review.13 Effect of exercise (compared to diet and exercise) on weight, blood pressure and cholesterol is based on a Cochrane review (Shaw, 2006) that pooled results across 6 studies (Figure 5). 19 Certainty of evidence for these
outcomes is low due to serious risk of bias associated with unclear randomization and allocation concealment processes, lack of blinding of assessors, inconsistent effect estimates, indirectness of these outcomes as measures of cardiovascular status as well as differences across types of exercise and diet interventions resulting in high heterogeneity for diastolic blood pressure, cholesterol and weight change. (86%, 54% and 41% respectively). Exercise minimally reduced weight by 0.65 kg ( 0.32), diastolic blood pressure by 0.94 mmHg (0.94), systolic blood pressure by 0.11
mmHG (1.14) and was associated with an insignificant increase in cholesterol of 0.03 mmol/L (0.1). Similarly, a more recent single RCT found
that weight loss was insignificantly reduced by 1 kg ( 3, P=0.67) in the exercise and diet group compared to the diet alone group. 32 This study
also reported impact of exercise on BMD. Although BMD was lower in both groups it decreased less in the diet and exercise group compared to
the diet only group 0.016 g/m2 less ( 0.02) in the diet and exercise group. Certainty of evidence is very low due to unclear randomization and al-
77
Management of Overweight and Obese
Adults
location concealment processes, as well as indirectness of BMD as a fracture and imprecision of this single, small study (n=54). 34 One patient important outcome of reduced knee pain due to osteoarthritis was evaluated by a single, high quality RCT (n= 79), that was downgraded to moderate certainty due to lack of assessor blinding. 35 The proportion of exercisers achieving 30% reduction in knee pain as measured by the Western
Ontario McMaster Osteoarthritis Index (WOMAC), score is 238 more per 1000 (NNT= 4, range 3 to 10) compared to dieters alone.35
Figure 5: Diet + Exercise vs Diet (Shaw, 2006)
Total Cholesterol
78
Management of Overweight and Obese
Adults
DBP
SBP
79
Management of Overweight and Obese
Adults
Weight
80
Management of Overweight and Obese
Adults
81
Evidence to Decision Framework: Should diet and physical activity compared to physical activity alone be used for obese and overweight adults
Criteria
Problem
Is there a problem
priority?
Judgements
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Obesity in Saudi Arabia is a growing health concern. Obese and overweight adults represent over 70% of the population.24 Females are
significantly more obese than males with a prevalence of 44%, compared to 26%, while overweight is significantly more prevalent among
males (42.4%) compared to females (31.8%). 25 Obesity and overweight are well known risk factors for diabetes, coronary artery disease, hypertension, breathing and sleep disorders, as well as impaired
quality of life
○ No included stud-
The relative importance or values of the main outcomes of interest:
ies
What is the overall
certainty of this evidence?
Benefits & harms
of the options
Additional considerations
Research evidence
● Very low
○ Low
○ Moderate
○ High
○ Important uncertainty or variability
○ Possibly important uncertainty
or variability
Is there important
uncertainty about how
Probably no immuch people value the portant uncertainty
main outcomes?
of variability
○
● No important
uncertainty of variability
○ No known unde-
Outcome
Relative importance
Certainty of the evidence (GRADE)
Change body weight
CRITICAL
⨁◯◯◯
VERY LOW
Change in systolic blood
pressure
CRITICAL
⨁◯◯◯
VERY LOW
Knee pain, % achieving
>30% reduction in
(WOMAC) score
CRITICAL
⨁⨁⨁◯
MODERATE
Change in diastolic blood
press
CRITICAL
⨁◯◯◯
VERY LOW
Patient values, preferences:
Impact of obesity (BMI
≥ 26 mg/kg2) on
health-related quality
of life (across multiple
utility measures:
EQ5D, EuroQol, VAS
and SF6D) suggests
significantly more
problems with pain,
mobility, role limitations and social functioning compared to
those who are preobese or overweight.
(Keating et al. 2007)
Management of Overweight and Obese
Adults
Criteria
82
Judgements
sirable
Are the desirable anticipated effects
large?
Are the undesirable
anticipated effects
small?
Are the desirable effects large relative to
undesirable effects?
○ No
● Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Additional considerations
Research evidence
Summary of findings: diet
Without
diet and
exercise
Relative
ef ect
(RR)
(95% CI)
With diet and
exercise
Difference
(95% CI)
The mean
change
Change body body weight
weight
in the control group
was 0
The mean
change body
weight in the
intervention
group was 0.65
lower (0.97
lower to 0.33
lower)
mean 0.65
lower
(0.97 lower to
0.33 lower)
-
Change in
systolic
blood pressure
The mean
change in
systolic
blood pressure in the
control
group was 3.2 mmHg
The mean
change in systolic blood
pressure in the
intervention
group was 0.11
lower (1.45
lower to 1.25
higher)
mean 0.11
lower
(1.45 lower to
1.25 higher)
-
Knee pain,
% achieving
>30% reduction in
(WOMAC)
score
230 per
1000
468 per 1000
(334 to 607)
238 more per
1000 (from
104 more to
378 more)
OR 2.95
(1.68 to
5.19)
Change in
diastolic
blood press
The mean
change in
diastolic
blood press
in the control group
was -2.066
mmHg
The mean
change in diastolic blood
press in the
intervention
group was 0.94
lower (1.89
lower to 0
higher)
mean 0.94
lower
(1.89 lower to
0 higher)
-
Outcome
Management of Overweight and Obese
Adults
Criteria
Judgements
Are the resources required small?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Is the incremental
cost small relative to
the net benefits?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Resource use
Equity
83
What would be the
impact on health inequities?
○ Increased
○ Probably increased
○ Uncertain
○ Probably reduced
○ Reduced
Research evidence
Additional considerations
The relevant
healthcare professional to monitor use may
be a GP, dietician or
specialist nurse, depending on access to
the type of provider.
Health professional
visit fees provided by
KSA panel below:
General physician:
300 SR
Diabetic Educator:
250SR
Nutritionist: 250 SR
Behavioural Specialist:
400 SR
Management of Overweight and Obese
Adults
Criteria
84
Judgements
Research evidence
Additional considerations
○ Varies
● N/A
Acceptability
Feasibility
Is the option acceptable to key stakeholders?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Is the option feasible
to implement?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Patient compliance
may be a barrier to
successful implementation.
Management of Overweight and Obese
Adults
85
Recommendation
Should diet and physical activity vs. diet be used for obese and overweight adults?
Balance of
consequences
Undesirable consequences
clearly outweigh desirable
consequences in most settings
Undesirable consequences
probably outweigh desirable
consequences in most settings
The balance between desirable
and undesirable consequences
is closely balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in most
settings
Desirable consequences
clearly outweigh undesirable
consequences in most settings
○
○
○
○
●
Type of recommendation
We recommend against offering this
option
We suggest not offering this
option
We suggest offering this
option
We recommend offering this
option
○
○
○
●
Recommendation
The panel recommends physical activity in addition to diet rather than a diet alone in overweight or obese adults.
Justification
There is a health benefit with no apparent downsides.
Subgroup considerations
Data available for this evidence profile derives from structured exercise (Shaw, 2006; Villareal 2009, Jenkinson 2011)
Implementation considerations
Addition of physical activity to diet may be important for maintaining any weight loss achieved with diet.
Monitoring and evaluation
None
Research possibilities
None
Management of Overweight and Obese
Adults
86
Evidence Profile
Author(s): Ainsley Moore
Date: Jan 9, 2015
Question: Diet and physical activity compared to diet for obese and overweight adults
Settings: Mixed
Bibliography (systematic reviews): Jenkinson, 2009; Shaw, 2009; Villareal 2011
Quality assessment
№ of studies
Study design
Risk of
bias
Inconsistency
№ of patients
Indirectness
Imprecision
Other considerations
Effect
Quality
Importance
diet and
exercise
diet
Relative
(95% CI)
Absolute
(95% CI)
none
595
484
-
mean 0.65 lower
(0.97 lower to 0.33
lower)
⨁◯◯◯
VERY LOW
CRITICAL
none
309
306
-
mean 0.11 lower
(1.45 lower to 1.25
higher)
⨁◯◯◯
VERY LOW
CRITICAL
Change body weight (follow up: mean 1 years; assessed with: mean kg)
15
randomised
trials
serious 1 2 3
serious
4
serious
5
not serious
Change in systolic blood pressure (follow up: mean 1 years; assessed with: mean mmHg)
6
randomised
trials
serious 1 2 3
serious
4
serious
5
not serious
Knee pain, % achieving >30% reduction in (WOMAC) score (follow up: mean 24 months; assessed with: % achieving outcome)
1
randomised
trials
serious 8
not serious
not serious
not serious
none
51/109
(46.8%)
28/122
(23.0%)
OR 2.95
(1.68 to
5.19)
238 more per 1000
(from 104 more to
378 more)
⨁⨁⨁◯
MODERATE
CRITICAL
none
309
306
-
mean 0.94 lower
(1.89 lower to 0
higher)
⨁◯◯◯
VERY LOW
CRITICAL
none
315
304
-
mean 0.03 higher
(0.07 lower to 0.13
higher)
⨁◯◯◯
VERY LOW
Change in diastolic blood press (follow up: mean 1 years; assessed with: mean mmHg)
6
randomised
trials
serious 1 2 3
serious
4
serious
5
not serious
Change in cholesterol (follow up: mean 1 years; assessed with: mean mmol/L)
6
randomised
trials
serious 1 2 3
serious
4
serious
5
serious
6
Management of Overweight and Obese
Adults
87
Change in bone density (follow up: mean 1 years; assessed with: mean g/m2)
1
randomised
trials
serious 1 2
not serious
serious
7
serious
none
28
26
Serious6
none
212
195
-
mean 0.016 higher
(0.004 lower to
0.036 higher)
⨁◯◯◯
VERY LOW
mean -0.01
(-0.11 lower to 0.07
higher)
⨁◯◯◯
VERY LOW
Fasting Serum Glucose, mean 1 years; assessed with (mmol/L)
4
RCT
Serious
123
Inconsistency
Serious 4
Serious5
MD – mean difference, RR – relative risk
1.
2.
3.
4.
5.
6.
7.
8.
Randomization process unclear
Allocation concealment unclear
Blinded assessors infrequent (3 studies)
Variation in diet and exercise delivery
Indirect outcome for cardiovascular status
Wide margin of confidence around mean effect of cholesterol
Indirect outcome for frailty
Assessors not blinded
Management of Overweight and Obese
Adults
88
Guideline Question 8: Should portion-controlled diet compared to non-portion controlled diet be used for obese and overweight adults?
Population
Intervention
Comparison
Outcomes
General population of obese adults with type 2 diabetes
Portion-controlled diet
no PCD
Weight change
Physiological parameters: systolic and diastolic blood pressure, cholesterol
Bone mineral Density (BMD)
Knee pain
Background:
Portion-controlled meals can be commercially prepared meals, specifically designed for convenience, ease of incorporation into an individual’s
lifestyle, and are intended to improve long-term dietary adherence. This question specifically addresses the effect of portion-controlled diet
against standard diet and is based on a single, long-term (36 month) RCT (n= 126). 23
Evidence summary:
Studies compared portion-controlled diet using Medifast Plus for Diabetics meal replacements with self-selected diet prescription of 25% energydeficit. The certainty of evidence for effect of portion-controlled diet is very low due to serious risk of bias associated with unclear randomization
and allocation concealment processes, indirectness of outcomes as measures of cardiovascular status, wide confidence margins around effect estimates and high attrition rate -42% in the portion controlled group.23 The ability of participants to achieve 10% weight loss in this trial was found
to be 231 more per 1000, (NNT = 4, range 71 to 1), while systolic blood pressure decreased by 10 mmHg ( 8.67), diastolic blood pressure by 5.6
mmHg (4.8) and cholesterol by 14.3 mg/dL (21). While overall quality of evidence remains very low, the quality of evidence for medication reduction was upgraded from very low, to low because of directness of this patient important outcome. The ability of diabetic participants in the
portion-controlled diet group to reduce medications is 240 more per 1000, NNT = 4, range 45 to 1). High attrition rates indicate intolerance for
sustained portion-controlled diet adherence.
Management of Overweight and Obese
Adults
89
Evidence to Decision Framework: Should portion controlled vs non-portion controlled diet be used in obese and overweight adults?
Criteria
Problem
Is there a
problem priority?
What is the
overall certainty of this
evidence?
Benefits &
harms of
the options
Judgements
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Obesity in Saudi Arabia is a growing health concern. Obese and overweight
adults represent over 70% of the population.24 Females are significantly
more obese than males with a prevalence of 44%, compared to 26%, while
overweight is significantly more prevalent among males (42.4%) compared
to females (31.8%). 25 Obesity and overweight are well known risk factors for
diabetes, coronary artery disease, hypertension, breathing and sleep disorders, as well as impaired quality of life
○ No included studies
● Very low
○ Low
○ Moderate
○ High
The relative importance or values of the main outcomes of interest:
○ Important uncertainty
Is there important uncertainty about
how much
people value
the main outcomes?
Additional considerations
Research evidence
or variability
○ Possibly important
uncertainty or variability
○ Probably no important
Outcome
Relative importance
> 10% weight loss
CRITICAL
⨁◯◯◯
VERY LOW
Systolic blood pressure
CRITICAL
⨁◯◯◯
VERY LOW
Total cholesterol
CRITICAL
⨁◯◯◯
VERY LOW
Reduced medications
CRITICAL
⨁⨁◯◯
LOW
Diastolic blood pressure
CRITICAL
⨁◯◯◯
VERY LOW
uncertainty of variability
● No important uncertainty of variability
Certainty of the evidence
(GRADE)
Summary of findings: non-portion controlled diet
Patient values, preferences:
Impact of obesity (BMI ≥
26 mg/kg2) on healthrelated quality of life
(across multiple utility
measures: EQ5D, EuroQol, VAS and SF6D)
suggests significantly
more problems with pain,
mobility, role limitations
and social functioning
compared to those who
are pre-obese or overweight.
(Keating et al. 2007)
Management of Overweight and Obese
Adults
Criteria
90
Judgements
○ No known undesirable
Are the desirable anticipated effects
large?
Are the undesirable anticipated effects
small?
Are the desirable effects
large relative
to undesirable
effects?
○ No
○ Probably no
● Uncertain
○ Probably yes
○ Yes
○ Varies
○ No
○ Probably no
● Uncertain
○ Probably yes
○ Yes
○ Varies
○ No
○ Probably no
● Uncertain
Additional considerations
Research evidence
Without portion controlled diet
With portion
controlled diet
> 10% weight
loss
59 per 1000
290 per 1000
(45 to 781)
231 more per
1000 (from 14
fewer to 722
more)
OR 6.54
(0.75 to
56.92)
Systolic blood
pressure
The mean systolic blood
pressure in the
control group
was 138.2
mmHg
The mean systolic blood
pressure in the
intervention
group was 10.6
lower (18.67
lower to 2.88
lower)
mean 10.6
lower
(18.67 lower to
2.88 lower)
-
Total cholesterol
The mean total
cholesterol in
the control
group was
52.2 mg/dl
The mean total
cholesterol in
the intervention
group was 14.3
lower (35.3
lower to 6.55
higher)
mean 14.3
lower
(35.3 lower to
6.55 higher)
-
Reduced medications
38 per 1000
240 per 1000
(859 to 17)
202 more per
1000 (from 22
fewer to 821
more)
OR 7.9
(152.27 to
0.42)
Diastolic blood
pressure
The mean diastolic blood
pressure in the
control group
was 83.2
mmHg
The mean diastolic blood
pressure in the
intervention
group was 5.6
lower (10.36
mean 5.6
lower
(10.36 lower to
0.84 lower)
-
Outcome
Difference
(95% CI)
Relative
effect (RR)
(95% CI)
Management of Overweight and Obese
Adults
Criteria
91
Judgements
Research evidence
○ Probably yes
○ Yes
○ Varies
Are the resources required small?
Resource
use
Is the incremental cost
small relative
to the net
benefits?
lower to 0.84
lower)
Resources required for
commercial preparations
are most likely not small.
It is uncertain owing to
lack of data what would
be the cost associated
with home-made portion
control diets.
○ No
○ Probably no
○ Uncertain
○ Probably yes
○ Yes
● Varies
○ No
● Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
Additional considerations
No ICER available
Management of Overweight and Obese
Adults
Criteria
Equity
Acceptability
Feasibility
92
Judgements
What would be
the impact on
health inequities?
○ Increased
● Probably increased
○ Uncertain
○ Probably reduced
○ Reduced
○ Varies
Is the option
acceptable to
key stakeholders?
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Is the option
feasible to implement?
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
Research evidence
Out of pocket expense for specialized diet foods considered costly
Additional considerations
Management of Overweight and Obese
Adults
93
Recommendation
Should portion controlled diet vs. non-portion controlled diet be used for obese and overweight adults?
Balance of consequences
Undesirable consequences
clearly outweigh
desirable consequences in
most settings
Undesirable consequences
probably outweigh desirable consequences in most
settings
The balance between desirable and undesirable
consequences is closely
balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in
most settings
Desirable consequences
clearly outweigh undesirable consequences in most
settings
○
○
●
○
○
Type of recommendation
We recommend against offering this
option
We suggest not offering this
option
We suggest offering this
option
We recommend offering this
option
○
○
○
○
Recommendation
The panel does not make a clinical recommendation. The panel recommends that more research is done.
Justification
Resources required for implementation are likely high and there is not enough evidence to determine whether there is a benefit or not.
Subgroup considerations
None
Implementation considerations
Standardization of diet if made at home may be a barrier for successful implementation.
Monitoring and evaluation
None
Research possibilities
The panel suggests more research on portion controlled diet strategies for weight loss
Management of Overweight and Obese
Adults
94
Evidence Profile
Author(s): Ainsley Moore
Date: Jan 9, 2015
Question: Portion controlled diet compared to non-portion controlled diet for obese and overweight adults
Settings: Mixed
Bibliography (systematic reviews): Cheskin, 2008
Quality assessment
№ of
studies
Study design
Risk of
bias
№ of patients
Inconsistency Indirectness
Imprecision
Other considerations
portion
controlled
diet
Effect
non-portion
controlled
diet
Relative
(95% CI)
Absolute
(95% CI)
9/31
(29.0%)
1/17
(5.9%)
OR 6.54
(0.75 to 56.92)
231 more per 1000 (from
14 fewer to 722 more)
⨁◯◯◯
VERY LOW
CRITICAL
31
17
-
mean 10.6 lower
(18.67 lower to 2.88 lower)
⨁◯◯◯
VERY LOW
CRITICAL
31
17
-
mean 14.3 lower
(35.3 lower to 6.55 higher)
⨁◯◯◯
VERY LOW
CRITICAL
OR 7.9
(152.27 to 0.42)
202 more per 1000 (from
22 fewer to 821 more) 1
⨁⨁◯◯
LOW
CRITICAL
-
mean 5.6 lower
(10.36 lower to 0.84 lower)
⨁◯◯◯
VERY LOW
CRITICAL
Quality
Importance
> 10% weight loss (follow up: mean 36 weeks; assessed with: prevalence/subjcts achievig weight loss)
1
randomised
trials
serious
23
not serious
serious
5
serious
4
none
Systolic blood pressure (follow up: mean 36 weeks; assessed with: mean change (mmHg))
1
randomised
trials
serious
23
not serious
serious
5
serious
4
none
Total cholesterol (follow up: mean 36 weeks; assessed with: mean change (mg/dL))
1
randomised
trials
serious
23
not serious
serious
5
serious
4
none
Reduced medications (follow up: mean 36 months; assessed with: prevalence able to reduce medication for glucose control)
1
randomised
trials
serious
23
not serious
not serious
serious
4
none
7/29
(24.1%)
0.5/13
(3.8%)
Diastolic blood pressure (follow up: mean 36 months; assessed with: mean mmHg)
1
randomised
trials
1.
2.
3.
4.
5.
serious
23
not serious
serious
5
serious
No explanation was provided
concealment not reported
loss to follow up
small single study, large confidence interval
outcome indirect measure for cardiovascular disease
4
none
Management of Overweight and Obese
Adults
95
Guideline Question 9: Should metformin compared to no metformin be used for overweight and obese adults?
Population
Intervention
Comparison
Outcomes
Mixed overweight and obese population (predominantly women with Polycystic Ovarian Syndrome)
Metformin
Placebo
BMI
Physiological parameters: systolic blood pressure, diastolic blood pressure,
total cholesterol
Adverse events
Background:
The cornerstone of obesity treatment is lifestyle changes. In view of the low success rate in achieving weight loss and even lower success rate for maintaining this weight loss, drug therapy for obesity in conjunction with lifestyle changes are often used. 14,31,33,40, Evidence suggests that metformin therapy alone
contributes to weight loss14, although its use for obesity is considered off-label in most jurisdictions.
Evidence summary:
Quality of evidence and overall certainty of effectiveness of metformin is moderate. A meta-analysis derived from the NHMRC systematic review
on insulin-sensitizing dugs for weight loss in women pooled estimates across 8 trials (Figure 6).24 This analysis found metformin use (1500 mg OD)
to be associated with approximately 1 unit ( 0.5) reduction in BMI (n = 372). 24
The large, multi-centre Diabetes Prevention Outcomes Study (n=1938) 41 also derived from the NHMRC review found decreased incidence of diabetes associated with metformin (850 mg BID) use (NNT = 33, over 2.8 years). This study did not find improved physiological parameters (systolic,
diastolic blood pressure or cholesterol levels). Our literature update identified a recent moderate quality study of hypertensive obese patients (n=
360) who were treated with 500 mg metformin od for 12 weeks.42 A clinically small, but statistically significant change in weight loss (p=0.006) of
0.7 kg (1.59) lower was found in the metformin compared to placebo group. Treatment effect in this study was likely limited by the low dose of
metformin (500mg OD) and the short duration of follow-up (24 weeks).
The quality and certainty of evidence regarding adverse events is low. Pooling was not possible due to different reporting methods and types of
events recorded. Side effects of nausea, abdominal cramps and diarrhoea are common, ranging from 17-40 % among metformin users vs 7-8% in
placebo groups. 42
Management of Overweight and Obese
Adults
Figure 6: High Dose Metfromin (1500 mg od) vs placebo- Body Mass Index (NHMRC, 2013)
96
Management of Overweight and Obese
Adults
97
Evidence to Decision Framework: Should metformin compared to no metformin be used for overweight and obese adults?
Criteria
Problem
Is there a problem priority?
What is the overall certainty of this evidence?
Benefits &
harms of
the options
Is there important uncertainty about how
much people value the
main outcomes?
Are the desirable anticipated effects large?
Judgements
Research evidence
Obesity in Saudi Arabia is a growing health concern. Obese and overweight adults represent over 70% of the population.24 Females are significantly more obese than males with a prevalence of 44%, compared to
26%, while overweight is significantly more prevalent among males
(42.4%) compared to females (31.8%). 25 Obesity and overweight are well
known risk factors for diabetes, coronary artery disease, hypertension,
breathing and sleep disorders, as well as impaired quality of life
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
○
○
●
○
○
No included studies The relative importance or values of the main outcomes of interest:
Very low
Certainty of the evidence
Outcome
Relative importance
Low
(GRADE)
Moderate
High
⨁⨁⨁◯
Body Mass Index
CRITICAL
MODERATE
○ Important uncertainty or variability
○ Possibly important
uncertainty or variability
● Probably no important uncertainty
of variability
○ No important uncertainty of variability
○ No known undesirable
○ No
● Probably no
○ Uncertain
Additional considerations
Systolic Blood Pressure
CRITICAL
⨁⨁⨁◯
MODERATE
Diastolic Blood Pressures
CRITICAL
⨁⨁⨁◯
MODERATE
Total Cholesterol
CRITICAL
⨁⨁⨁◯
MODERATE
Adverse events
CRITICAL
⨁⨁◯◯
LOW
Incidence of Diabetes
CRITICAL
⨁⨁⨁◯
MODERATE
Weight
CRITICAL
⨁⨁⨁◯
MODERATE
Patient values, preferences:
Impact of obesity
(BMI ≥ 26 mg/kg2)
on health-related
quality of life (across
multiple utility
measures: EQ5D,
EuroQol, VAS and
SF6D) suggests significantly more problems with pain, mobility, role limitations
and social functioning compared to
those who are preobese or overweight.
(Keating et al. 2007)
Panel members
thought that undesirable effects will be
large in some but
Management of Overweight and Obese
Adults
98
Criteria
Judgements
○ Probably yes
○ Yes
○ Varies
Are the undesirable anticipated effects small?
○
○
○
○
○
●
○
○
Are the desirable effects ○
large relative to unde●
○
sirable effects?
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
No
Probably no
Uncertain
Probably yes
Yes
Varies
Additional considerations
Research evidence
not in all patients.
Summary of findings: no metformin
Without metformin
Relative
effect
(RR)
(95% CI)
With metformin
Difference
(95% CI)
Body Mass
Index
The mean
body Mass
Index in the
control group
was 33.9 BMI
(kg/m2)
The mean body
Mass Index in
the intervention group was
0.98 lower
(1.51 lower to
0.45 lower)
mean 0.98
lower
(1.51 lower to
0.45 lower)
-
Systolic Blood
Pressure
The mean systolic Blood
Pressure in the
control group
was 122.3
mmHg
The mean systolic Blood
Pressure in the
intervention
group was 0.4
higher (1.2
lower to 2.01
higher)
mean 0.4
higher
(1.2 lower to
2.01 higher)
-
The mean diastolic Blood
Pressures in
the intervention group was
0.7 higher
(0.02 higher to
1.38 higher)
mean 0.7
higher
(0.02 higher to
1.38 higher)
The mean total
Cholesterol in
the intervention group was
mean 0.01
lower
(0.11 lower to
0.09 higher)
Outcome
The mean diastolic Blood
Diastolic Blood Pressures in
Pressures
the control
group was
75.2 mmHg
Total Cholesterol
The mean total
Cholesterol in
the control
group was
-
Management of Overweight and Obese
Adults
99
Criteria
Judgements
5.08 mmol/l
Adverse
events
Incidence of
Diabetes
Weight
Are the resources required small?
Resource
use
Is the incremental cost
small relative to the net
benefits?
Additional considerations
Research evidence
0.01 lower
(0.11 lower to
0.09 higher)
Effect not estimable. Side-effects (nausea, abdominal cramps
and diarrhoea) reported inconsistently in 4/14 studies, number
of events range 8 - 20 out of 12-69 people in metformin group
vs 1-5 events out of 12-69 people in placebo group
110 per 1000
78 per 1000
(58 to 103)
30 fewer per
1000 (from 70
fewer to 77
more)
The mean
weight in the
control group
was 0
The mean
weight in the
intervention
group was 1.92
lower (2.94
lower to 0.89
lower)
mean 1.92
lower
(2.94 lower to
0.89 lower)
RR 0.73
(0.36 to
1.70)
-
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
Cost will vary with dose and duration of therapy, intervention treatments ranged
500 mg od to 850 mg BID for 2 months to 3 years.
Cost per month of metformin treatment provided by KSA panel is 20 SR
○
○
●
○
○
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
ICER not available
Management of Overweight and Obese
Adults
100
Criteria
Equity
Acceptability
Feasibility
What would be the impact on health inequities?
Is the option acceptable
to key stakeholders?
Is the option feasible to
implement?
Judgements
○
○
○
○
○
○
●
Increased
Probably increased
Uncertain
Probably reduced
Reduced
Varies
N/A
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
Research evidence
Additional considerations
KSA panel advises
this would be an
acceptable option to
the Saudi population,
barriers relate to
lack of awareness of
effectiveness
Management of Overweight and Obese
Adults
101
Recommendation
Should metformin vs. no metformin be used for obese and overweight adults?
Balance of
consequences
Undesirable consequences
clearly outweigh desirable
consequences in most settings
Undesirable consequences
probably outweigh desirable
consequences in most settings
The balance between desirable
and undesirable consequences
is closely balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in most
settings
Desirable consequences
clearly outweigh undesirable
consequences in most settings
○
○
○
●
○
Type of recommendation
We recommend against offering this
option
We suggest not offering this
option
We suggest offering this
option
We recommend offering this option
○
○
●
○
Recommendation
The panel suggests metformin in obese or overweight adults.
Justification
The weight loss with metformin is marginal but there is a small benefit with low adverse effects and low resources required.
Subgroup considerations
The benefits form metformin may be larger in patients with prediabetes and those with risk factors for diabetes.
Implementation considerations
None
Monitoring and evaluation
None
Research possibilities
RCTs in unselected obese and overweight patients that report all patient-important outcomes (e.g. quality of life, function, morbidity and
mortality) rather than surrogate outcomes only.
Economic analysis in Saudi Arabian health care system.
Management of Overweight and Obese
Adults
102
Evidence Profile
Author(s): Ainsley Moore
Date: Jan 9, 2015
Question: Metformin compared to no metformin for obese and overweight adults
Settings: Mixed
Bibliography (systematic reviews): Knowler, 2009 (RCT); Nieuwenhuis, 2009 (meta-analysis); Peirson, 2014 (Systematic review and meta-analysis)
Quality assessment
№ of
studies
Study design
Risk of
bias
Inconsistency
Indirectness
№ of patients
Imprecision
Other considerations
Effect
Quality
Importance
metformin
no metformin
Relative
(95% CI)
Absolute
(95% CI)
174
198
-
mean 0.98 lower
(1.51 lower to 0.45 lower)
⨁⨁◯◯
LOW
CRITICAL
652
608
-
mean 0.4 higher
(1.2 lower to 2.01 higher)
⨁⨁◯◯
LOW
CRITICAL
652
608
-
mean 0.7 higher
(0.02 higher to 1.38 higher)
⨁⨁◯◯
LOW
CRITICAL
652
608
-
mean 0.01 lower
(0.11 lower to 0.09 higher)
⨁⨁◯◯
LOW
CRITICAL
Body Mass Index (follow up: range 2-12 months; assessed with: Mean change (kg/m2))
8
randomised
trials
not
serious
not serious
very serious 1
not serious
none
Systolic Blood Pressure (follow up: mean 10 years; assessed with: mean change (mmHg))
1
randomised
trials
not
serious
not serious
very serious 1
not serious
none
Diastolic Blood Pressures (follow up: mean 10 years; assessed with: mean change (mmHg))
1
randomised
trials
not
serious
not serious
very serious 1
not serious
none
Total Cholesterol (follow up: mean 10 years; assessed with: mean change (mmol/L))
1
randomised
trials
not
serious
not serious
very serious 1
not serious
not serious
serious
none
Adverse events (assessed with: events/ %)
4
randomised
trials
not
serious
not serious
4
2
3
none
Effect not estimable. Side-effects (nausea, abdominal cramps and diarrhoea)
reported inconsistently in 4/14 studies,
number of events range 8 - 20 out of 1269 people in metformin group vs 1-5
events out of 12-69 people in placebo
group
CRITICAL
Management of Overweight and Obese
Adults
103
Incidence of Diabetes (follow up: mean 2.8 years; assessed with: new cases of DM per 100 patient years )
1
randomised
trials
not
serious
not serious
serious
1
not serious
none
not serious
none
7.8/100
(7.8%)
11/100
(11.0%)
RR 0.73
(0.36 to
0.1.7)
31 fewer per 1000 (from 70
fewer to 77 more)
⨁⨁⨁◯
MODERATE
CRITICAL
-
mean 0.7 lower
(2.29 lower to 0.89 higher)
⨁⨁⨁◯
MODERATE
CRITICAL
Change in weight (follow up: median 12 weeks; assessed with: Kg)
1
randomised
trials
not
serious
not serious
serious
1
MD – mean difference, RR – relative risk
1.
2.
3.
4.
outcome indirect measure of cardiovascular disease, also population is indirect evidence derives from a population of obese women of reproductive age with polycystic ovarian syndrome
inconsistent reporting different type of side effects
wide range of side effect events reported
Incomplete reporting of adverse event outcomes across studies
Management of Overweight and Obese
Adults
104
Guideline Question 10: Should orlistat compared to no orlistat be used for overweight and obese adults?
Population
Intervention
Comparison
Outcomes
Mixed overweight and obese adults (hypertensive, diabetic, general population)
Orlistat
Lifestyle interventions
Change in weight
Physiological parameters: systolic and diastolic blood Cardiovascular morbidity
Mortality
Background:
The cornerstone of obesity treatment is lifestyle changes. In view of the low success rate in achieving weight loss and even lower success rate for maintaining this weight loss, drug therapy for obesity in conjunction with lifestyle changes is often advised.31,33 Orlistat is a lipase inhibitor, which prevents absorption of approximately 25% of fat consumed and is the main anti-obesity drug approved for long-term treatment of obesity.31 Evidence suggests that orlistat
therapy alone contributes to weight loss. 13 In some jurisdictions (e.g. U.S.) orlistat is over the counter, suggesting a high safety profile.
Evidence summary:
A meta-analysis from the NHMRC review across 11 trials informs this question. Additionally, an older Cochrane review based on 4 RCTs derived
from the NHMR provides descriptive summaries for adverse events, mortality and myocardial infarctions.13,25
Moderate quality evidence from a meta-analysis of 11 RCTs (n= 2058) found that treatment with orlistat 120 mg TID over 3.5 years decreased systolic blood
pressure by 1.82 mm Hg ± 0.43.13
Moderate quality evidence from a meta-analysis of 11 RCTs (n= 2058) found that treatment with orlistat, 120 mg TID over 3.5 years decreased diastolic
blood pressure by 1.56 mm Hg ± 0.69.13
Moderate quality evidence from a meta-analysis of 11 RCTs (n= 2080-for this outcome) found that treatment with orlistat, 120 mg TID over 3.5 years decreased body weight by 3.38 kg ± 0.41 13
Low quality of evidence for adverse events is summarized descriptively from 4 trials as reported in a Cochrane review.25 The majority of individuals (up to
73%) in the orlistat groups reported side-effects of steatorrhoea, fatty faecal incontinence, frequent or urgent bowel movements.
Evidence for mortality is low and reported descriptively. There were two deaths in 3 RCTs in the orlistat group over 12 months compared to no deaths in
the placebo group. 25
Evidence for myocardial infarction is low and reported descriptively. There were two myocardial infarctions in 2 RCTs, compared to 1 in the placebo
groups.25
Management of Overweight and Obese
Adults
Figure 7: Orlistat vs no orlistat: Diastolic Blood Pressure, Systolic Blood Pressure, Weight (NHMRC, 2013)
105
Management of Overweight and Obese
Adults
106
Management of Overweight and Obese
Adults
107
Evidence to decision Framework: Should orlistat compared to no orlistat be used for overweight and obese adults?
Criteria
Problem
Benefits &
harms of
the options
Judgements
Is there a problem priority?
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
What is the
overall certainty of this evidence?
○
○
○
●
○
No included studies
Very low
Low
Moderate
High
Is there important uncertainty about
how much people value the
main outcomes?
○ Important uncertainty or
variability
○ Possibly important uncertainty or variability
○ Probably no important
uncertainty of variability
● No important uncertainty
of variability
○ No known undesirable
Are the desirable anticipated
effects large?
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
○
○
○
●
No
Probably no
Uncertain
Probably yes
Are the undesirable anticipated effects
small?
Additional considerations
Research evidence
Obesity in Saudi Arabia is a growing health concern. Obese and overweight
adults represent over 70% of the population.24 Females are significantly
more obese than males with a prevalence of 44%, compared to 26%, while
overweight is significantly more prevalent among males (42.4%) compared
to females (31.8%). 25 Obesity and overweight are well known risk factors
for diabetes, coronary artery disease, hypertension, breathing and sleep
disorders, as well as impaired quality of life
The relative importance or values of the main outcomes of interest:
Relative importance
Outcome
Certainty of the evidence
(GRADE)
Systolic Blood pressure
CRITICAL
⨁⨁⨁◯
MODERATE
Diastolic Blood Pressure
CRITICAL
⨁⨁⨁◯
MODERATE
Change in body weight
CRITICAL
⨁⨁⨁◯
MODERATE
Adverse events
CRITICAL
Mortality
CRITICAL
Cardiovascular morbidity
CRITICAL
Summary of findings: no orlistat
Outcome
Without
orlistat
With orlistat
Difference
(95% CI)
Relative
effect
(RR)
(95% CI)
Patient values, preferences:
Impact of obesity
(BMI ≥26 mg/kg2) on
health-related quality
of life (across multiple
utility measures:
EQ5D, EuroQol, VAS
and SF6D) suggests
significantly more
problems with pain,
mobility, role limitations and social functioning compared to
those who are preobese or overweight.
(Keating et al. 2007)
With respect to desirable anticipated effects, one panel
member was unsure
and thought they
were probably large
(i.e. ‘probably yes’ as
Management of Overweight and Obese
Adults
Criteria
108
Judgements
○ Yes
○ Varies
○
○
○
●
○
○
Are the desirable effects large
relative to undesirable effects?
No
Probably no
Uncertain
Probably yes
Yes
Varies
Additional considerations
Research evidence
opposed to ‘yes’).
Systolic Blood
pressure
The mean
systolic Blood
pressure
ranged
across control
groups from 11 to -0.9
mmHg
The mean systolic Blood
pressure in the
intervention
group was 1.82
lower (2.36
lower to 1.26
lower)
mean 1.82
lower
(2.36 lower to
1.26 lower)
-
Diastolic Blood
Pressure
The mean
diastolic
Blood Pressure ranged
across control
groups from 9 to -.8
mmHg
The mean diastolic Blood
Pressure in the
intervention
group was 1.56
lower (2.25
lower to 0.87
lower)
mean 1.56
lower
(2.25 lower to
0.87 lower)
-
Change in body
weight
The mean
change in
body weight
ranged
across control
groups from 6.9 to -1.8
The mean
change in body
weight in the
intervention
group was 3.38
lower (3.79
lower to 2.98
lower)
mean 3.38
lower
(3.79 lower to
2.98 lower)
-
Adverse events
73% Orlistat group vs 44% placebo group reporting gastrointestinal side effects (p<.001). steatorrhoea, fatty faecal incontinence, frequent or urgent bowel movements. Concentrations of fat-soluble vitamins (e.g. vitamins A, D, E and K) are
reduced with orlistat, however they remain in the normal
range (Torgerson et al. 2004),
Mortality
Mortality Orlistat (2/407) vs placebo (0/437)
Cardiovascular
morbidity
Myocardial infarctions Olristat (2/267) vs placebo (1/265)
Management of Overweight and Obese
Adults
Criteria
Are the resources required small?
109
Judgements
○
○
○
○
●
○
○ No
Is the incre○ Probably no
mental cost
○ Uncertain
small relative to
● Probably yes
the net bene○ Yes
fits?
○ Varies
What would be
the impact on
health inequities?
○
●
○
○
○
○
Increased
Probably increased
Uncertain
Probably reduced
Reduced
Varies
Is the option
acceptable to
Acceptability
key stakeholders?
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
Is the option
feasible to implement?
○
○
○
○
●
○
No
Probably no
Uncertain
Probably yes
Yes
Varies
Feasibility
Additional considerations
250 SR per month
currently not reimbursed in most primary care settings. Will
also include cost of
multivitamin supplementation if needed.
No
Probably no
Uncertain
Probably yes
Yes
Varies
Resource
use
Equity
Research evidence
Cost-effectiveness studies of orlistat use show that it is not cost-effective for population-based outcomes but other data suggest that it is more cost-effective in individuals who have numerous comorbidities (type 2 diabetes, hypertension, hypercholesterolaemia) (Lacey et al. 2005).
Incremental Cost-Effectiveness Ratio in diabetic populations; $8327 (US dollars)
per event free life-year gained
Another ICER from Sweden 13,120 Euros/QALY ($17,000 Canadian)
Inequity issues could be related to out of pocket costs of medications that are not
reimbursed.
Some patients may
not continue therapy
because of AEs and
required frequency of
taking orlistat and
cost.
Management of Overweight and Obese
Adults
110
Recommendation
Should orlistat vs. no orlistat be used for obese and overweight adults?
Balance of
consequences
Undesirable consequences
clearly outweigh desirable
consequences in most settings
Undesirable consequences
probably outweigh desirable
consequences in most settings
The balance between desirable
and undesirable consequences
is closely balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in most
settings
Desirable consequences
clearly outweigh undesirable
consequences in most settings
○
○
○
●
○
Type of recommendation
We recommend against offering this
option
We suggest not offering this
option
We suggest offering this
option
We recommend offering this
option
○
○
●
○
Recommendation
The panel suggests orlistat in obese and overweight adults.
Justification
There is a benefit despite important AE.
Subgroup considerations
Availability of resources may have important impact on this recommendation. In settings with limited resources the opposite (i.e. not using
orlistat) may be equally reasonable.
Implementation considerations
Patients should know that they should expect AEs, avoid fatty meals. Orlistat decreases absorption of vitamins, so supplementation may be
warranted.
Monitoring and evaluation
None
Research possibilities
Economic analysis in Saudi Arabian health care system.
Studies investigating whether and when to use multivitamin supplementation.
Management of Overweight and Obese
Adults
111
Evidence Profile
Author(s): Ainsley Moore
Date: 2014-12-16
Question: Orlistat compared to no orlistat for obese and overweight adults
Settings: Mixed
Bibliography (systematic reviews): NHMRC (Bakris, 2003; Broom, 2002; Cocco, 2005; Davidson, 1999; Derosa, 2003; Guy -Grand, 2004; Hauptman, 2000; Rossner, 2000; Sjostrom, 1998;
Swinburn, 2005; Drew, 2007 (XENDOS), Cochrane review (Siebenhofer, 2009)
Quality assessment
№ of
studies
Study design
Risk of bias
Inconsistency
№ of patients
Indirectness
Imprecision
Other considerations
Effect
Quality
Importance
orlistat
no
orlistat
Relative
(95% CI)
Absolute
(95% CI)
1015
1043
-
mean 1.82 lower
(2.36 lower to 1.26 lower)
⨁⨁⨁◯
MODERATE
CRITICAL
none
1015
1043
-
mean 1.56 lower
(2.25 lower to 0.87 lower)
⨁⨁⨁◯
MODERATE
CRITICAL
none
1023
1057
-
mean 3.38 lower5
(3.79 lower to 2.98 lower)
⨁⨁⨁⨁
HIGH
CRITICAL
Systolic Blood pressure (follow up: range 3-4 years; assessed with: mean change (mmHg))
11
randomised
trials
not serious
not serious4
serious
3
not serious
none
Diastolic Blood Pressure (follow up: range 3-4 years; assessed with: mean change (mmHg))
11
randomised
trials
not serious
not serious
serious
3
not serious
Change in body weight (follow up: mean 12 months; assessed with: Mean change (kg))
11
randomised
trials
not serious
not serious
not serious 3
not serious
Adverse events (assessed with: gastrointestinal side effects (% reporting))
4
randomised
trials
not serious
serious
1
not serious
Mortality (follow up: mean 12 months; assessed with: (total events))
not serious 2
none
73% Orlistat group vs 44% placebo group reporting gastrointestinal side effects (p<.001). steatorrhoea, fatty faecal incontinence, frequent or
urgent bowel movements. Concentrations of fatsoluble vitamins (e.g. vitamins A, D, E and K) are
reduced with orlistat, however they remain in
the normal range (Torgerson et al. 2004), Case of
liver failure have been identified in a case report
(Montero, 2001; Kim, 2002)
CRITICAL
Management of Overweight and Obese
Adults
3
randomised
trials
serious
serious
112
2
not serious
serious
2
none
Mortality Orlistat (2/407) vs placebo (0/437)
CRITICAL
Myocardial infarctions Olristat (2/267) vs placebo
(1/265)
CRITICAL
Cardiovascular morbidity (follow up: mean 12 months; assessed with: Myocardial infarction (total number of patients))
2
randomised
trials
serious
serious
2
not serious
serious
2
none
MD – mean difference, RR – relative risk
1.
2.
3.
4.
5.
I sq = 36%
fewer studies reporting adverse events
outcome indirect for CVD
Effect estimates vary from favours comparator to orlistat (I sq = 50%)
3 kg weight loss translates to a 50% risk reduction in development of diabetes in pre-diabetes over 5 years (DPP trial)
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
Bakris G, Calhoun D, Egan B, Hellmann C, Dolker M, Kingma I. Orlistat and resistant hypertension investigators.Orlistat improves blood pressure control in obese
subjects with treated but inadequately controlled hypertension. J Hypertens. 2002;20:2257–67.
Broom I, Wilding J, Stott P, Myers N. UK Multimorbidity Study Group.Randomised trial of the effect of orlistat on body weight and cardiovascular disease risk profile in obese patients: UK Multimorbidity Study. Int J Clin Pract. 2002;56:494–9.
Cocco G, Pandolfi S, Rousson V. Sufficient weight reduction decreases cardiovascular complications in diabetic patients with the metabolic syndrome: A randomized study of orlistat as an adjunct to lifestyle changes (diet and exercise). HeartDrug 2005;5(2):68–74.
Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted CH, Heber D, et al.Weight control and risk factor reduction in obese subjects treated for 2 years with
orlistat: a randomized controlled trial.see comment]erratum appears in JAMA 1999 Apr 7;281(13):1174]. JAMA 1999;281(3): 235–42.
Derosa G, Mugellini A, Ciccarelli L, Fogari R. Randomized, double-blind, placebo-controlled comparison of the action of orlistat, fluvastatin, or both an anthropometric measurements, blood pressure, and lipid profile in obese patients with hypercholesterolemia prescribed a standardized diet. Clinical Therapeutics
2003;25(4):1107–22.
Hauptman et al. Orlistat in the long-term treatment of obesity in primary care settings. 2000. Arch Fam Med. 9(2): 160-167.
Guy-Grand B, Drouin P, Eschwege E, Gin H, Joubert JM, Valensi P. Effects of orlistat on obesity-related diseases – a six-month randomized trial. Diabetes, Obesity &
Metabolism 2004;6(5):375–83.
Rossner S, Sjostrom L, Noack R, Meinders AE, Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with
orlistat for obesity. European Orlistat Obesity Study Group. Obesity Research 2000;8(1):49–61.
Sjostrom L, Rissanen A, Andersen T, Boldrin M, Golay A, Koppeschaar HP, et al.Randomised placebo-controlled trial of orlistat for weight loss and prevention of
weight regain in obese patients. European Multicentre Orlistat Study Group.see comment]. Lancet 1998;352(9123):167–72.
Management of Overweight and Obese
Adults
113
10. Swinburn BA, Carey D, Hills AP, Hooper M, Marks S, Proietto J, et al. Effect of Orlistat on cardiovascular disease risk in obese adults. Diabetes Obes Metab.
2005;7:254–62
11. Swinburn BA, Carey D, Hills AP, Hooper M, Marks S, Proietto J, et al.Effect of orlistat on cardiovascular disease risk in obese adults. Diabetes, Obesity & Metabolism 2005;7 (3):254–62.
12. Drew B, et al. Obesity management: Update on Orlistat (XENDOS). 2007 3(6): 817-821.
13. Siebenhofer A, Horvath K, Jeitler K, Berghold A, Stich AK, Matyas E, Pignitter N & Siering U 2009, 'Long-term effects of weight-reducing drugs in hypertensive patients', Cochrane Database Syst Rev, no.3, pp.CD007654.
Management of Overweight and Obese
Adults
114
Guideline Question 11: Should bariatric surgery compared to non-surgical therapies be used for overweight and obese adults?
Population
Intervention
Comparison
Outcomes
Morbid or super obese population (BMI > 30)
Bariatric surgery
Non-surgical therapies – predominantly intensive lifestyle interventions
Weight, BMI
Remission of co-morbidities
Quality of life
Serious adverse events
Background:
Bariatric surgery in general carries risk of morbidity and peri-operative mortality. It is therefore considered when other treatments have failed. Risks with
bariatric surgery include; bleeding (0.5%), thromboembolic events (0.8%), wound complications (1.8%), deep infection-abscess or leak (2.1%), pulmonary
complications (6.2%), miscellaneous complications (4.8%), cholecystitis and mortality (0.52%).43 Large observational studies of bariatric surgery, confirms
effectiveness of major weight reduction and improvement in co-morbidities, which are reported in small, randomized trials.45
Summary of Findings:
Our literature update identified a meta-analysis of bariatric surgery within the 2014 Cochrane review by Colquitt.43 However comparisons within this review
did not address the surgical technique and comparator of interest to panel members (sleeve gastrectomy versus medical therapy). Panel members identified The RCT by Schauer, 2014 44 that specifically evaluated sleeve gastrectomy in comparison to medical therapy as important for consideration in the Saudi context and this RCT informs this question. Moderate quality of evidence from one RCT (n= 89) is found for mean systolic blood pressure reduction of 5.7
mmHg (± 8.3) in the surgically treated group compared to the medically treated group over 3 years. 44 Moderate quality of evidence from one RCT (n= 88)
found a reduction of those with glycosylated hemoglobin > 6% of 200 fewer per 1000 when treated surgically treated versus medically over 3 years (NNT =
5, range 17 to 3).44 Moderate quality of evidence from one RCT (n= 89) is found for weight reduction of 21 kg (± 6) in the surgically treated group compared
to the medically treated group over 3 years. 44 Moderate quality of evidence from one RCT (n= 88) found an increase of anemia 209 more per 1000 among
those treated surgically compared to those treated medically over 3 years (NNT = 5, range 142 to 2). 44
Management of Overweight and Obese
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115
Evidence to Decision Framework: Should bariatric surgery compared to non-surgical therapies be used for overweight and obese adult?
Criteria
Problem
Is there a problem priority?
Research evidence
○ No
○ Probably no
○ Uncertain
○ Probably yes
● Yes
○ Varies
Obesity in Saudi Arabia is a growing health concern. Obese and overweight adults
represent over 70% of the population.24 Females are significantly more obese
than males with a prevalence of 44%, compared to 26%, while overweight is significantly more prevalent among males (42.4%) compared to females (31.8%). 25
Obesity and overweight are well known risk factors for diabetes, coronary artery
disease, hypertension, breathing and sleep disorders, as well as impaired quality
of life.
○ No included
The relative importance or values of the main outcomes of interest:
studies
What is the overall certainty of
this evidence?
Benefits &
harms of
the options
○ Very low
○ Low
● Moderate
○ High
○ Important
Is there important uncertainty about how
much people value the main outcomes?
Additional considerations
Judgements
uncertainty or
variability
○ Possibly
important uncertainty or
variability
○ Probably no
Outcome
Relative importance
Certainty of the evidence
(GRADE)
Systolic blood pressure
change
CRITICAL
⨁⨁⨁◯
>6% Glycated Hemoglobin
CRITICAL
⨁⨁⨁◯
Anemia
CRITICAL
⨁⨁⨁◯
Weight
CRITICAL
⨁⨁⨁◯
MODERATE
MODERATE
MODERATE
MODERATE
Patient values and preferences:
Impact of obesity (BMI
≥ 26 mg/kg2) on
health-related quality of
life (across multiple
utility measures: EQ5D,
EuroQol, VAS and
SF6D) suggests significantly more problems
with pain, mobility, role
limitations and social
functioning compared to
those who are preobese or overweight.
(Keating et al. 2007)
Management of Overweight and Obese
Adults
Criteria
116
Judgements
important uncertainty of
variability
Summary of findings: Bariatric surgery compared to medical therapy for obese
and overweight adults
● No im-
portant uncertainty of variability
Additional considerations
Research evidence
Outcome
With medical
therapy
With bariatric
surgery
Difference
(95% CI)
Relative
effect
(RR)
(95% CI)
○ No known
Systolic
blood pressure change
The mean
systolic blood
pressure
change in the
control group
was 0.63
mmHg
The mean systolic
blood pressure
change in the intervention group
was 5.7 lower (14
lower to 4 higher)
MD 5.7 lower
(14 lower to 4
higher)
-
>6% Glycated Hemoglobin
950 per 1000
750 per 1000
(627 to 893)
200 fewer per
1000 (from 57
fewer to 323
fewer)
RR 0.789
(0.660 to
0.940)
Anemia
140 per 1000
349 per 1000
(147 to 823)
209 more per
1000 (from 7
more to 684
more)
RR 2.50
(1.05 to
5.90)
Weight
The mean
Weight in the
control group
was 100.2 Kg
The mean Weight
in the intervention
group was 21 lower
(14 lower to 27
lower)
MD 21 lower
(14 lower to
27 lower)
-
undesirable
Are the desirable
anticipated effects large?
Are the undesirable anticipated
effects small?
Are the desirable
effects large relative to undesira-
○ No
○ Probably no
○ Uncertain
○ Probably yes
○ Yes
● Varies
● No
○ Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
○ No
Management of Overweight and Obese
Adults
Criteria
ble effects?
Are the resources
required small?
117
Judgements
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
● No
○ Probably no
○ Uncertain
○ Probably yes
○ Yes
○ Varies
Large variability in cost estimates (Keating et al. 2009; Picot et al. 2009;
Sjöström et al. 2007; Vos et al. 2010). Major factors include; age, BMI, comorbidities, gender, type of surgery.
Direct and Indirect health system costs (health professional surgical fees, OR
time, hospital stay, cost of complications (wound infections, deep vein thrombosis, pulmonary embolism, leaks, cholecystectomy, incisional hernia abdominoplasty, surgical revision), follow-up, ongoing monitoring, sustained lifestyle
changes.
Range of costs for open gastric by-pass (most expensive procedure) in US dollars (Picot, 2009):
Men 35-55 years, BMI 40-50 $68,000-$85,300
Women 35-55 years, BMI 40- 50 %59,000-$77,000
Prevalence of BMI > 40 in Saudi Arabia, total eligible candidates (
total cost to system range ( ).
Resource
use
Is the incremental cost small relative to the net
benefits?
Additional considerations
Research evidence
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
). Potential
No studies directly compared bariatric surgery overall to non-surgical interventions
Open gastric by-pass (most expensive procedure) vs non-surgical interventions:
Men (35-55 years, BMI 40-50),
Incremental Cost Effectiveness Ratio: $10,000 - $28,000/QALY
Women(35-55 years, BMI - 40-50)
Incremental Cost Effectiveness Ratio: $ 5.400 - $14,700/QALY
Management of Overweight and Obese
Adults
Criteria
118
Judgements
○ Increased
● Probably
increased
Equity
What would be
the impact on
health inequities?
○ Uncertain
○ Probably
reduced
○ Reduced
○ Varies
Is the option acAcceptability ceptable to key
stakeholders?
Feasibility
Is the option feasible to implement?
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
○ No
○ Probably no
○ Uncertain
● Probably yes
○ Yes
○ Varies
Research evidence
Additional considerations
Panel members thought
it would increase inequity in access to
healthcare unless more
resources are available
and the procedure is
made available for
those with fewer resources
Management of Overweight and Obese
Adults
119
Recommendation
Should bariatric surgery vs. medical therapy be used for obese and overweight adults?
Balance of
consequences
Undesirable consequences
clearly outweigh desirable
consequences in most settings
Undesirable consequences
probably outweigh desirable
consequences in most settings
The balance between desirable and undesirable consequences is closely balanced or uncertain
Desirable consequences
probably outweigh undesirable consequences in most
settings
Desirable consequences
clearly outweigh undesirable consequences in most
settings
○
○
○
●
○
Type of recommendation
We recommend against offering this
option
We suggest not offering this
option
We suggest offering this option
We recommend offering
this option
○
○
●
○
Recommendation
The panel suggests using bariatric surgery to obese adults (BMI ≥40 or ≥35 with comorbidities).
Justification
This recommendation pertains to individuals with larger BMI since anticipated benefits are larger in the setting of individuals who are
at higher health risks due to morbid obesity compared to risks posed by surgery
Subgroup considerations
Data are considered for gastric sleeve surgery only
Implementation considerations
Patients need to be screened pre-operatively by trained physician for the presence of co-morbidities and other causes of obesity, including eating disorders. Post-operative multidisciplinary follow up is an additional implementation consideration
Monitoring and evaluation
Research possibilities
Long- term evaluation of benefits and complications are required. Studies involving patients with lower BMI (30-35) are required
Management of Overweight and Obese
Adults
120
Evidence Profile
Author(s): Ainsley Moore
Date: 2014-12-15
Question: Bariatric surgery-sleeve gastrectomy compared to medical therapy for obese and overweight adults
Setting: Mixed
Bibliography (systematic reviews): Schauer, 2014
Quality assessment
№ of
studies
Study design
Risk of
bias
№ of patients
Quality
bariatric
surgery
non-surgical therapies
Relative
(95% CI)
Absolute
(95% CI)
49
40
-
mean 5.7 lower
(14 lower to 4 higher)
⨁⨁⨁◯
MODERATE
none
2/40 (5.0%)
12/49 (24.5%)
RR 4.89
(1.16 to
20.60)
953 more per 1000
(from 39 more to 1000
more)
⨁⨁⨁◯
MODERATE
1
none
15/49
(30.6%)
6/43 (14.0%)
RR 2.50
(1.05 to
5.90)
209 more per 1000
(from 7 more to 684
more)
⨁⨁⨁◯
MODERATE
1
none
40
49
-
MD 21 lower
(14 lower to 27 lower)
⨁⨁⨁◯
MODERATE
Inconsistency Indirectness Imprecision
Other considerations
Effect
Importance
From Schauer, 2014 Hypertension (systolic blood pressure) (follow up: mean 3 years; assessed with: mmHg)
1
randomised
trials
not
serious
not serious
not serious
serious
1
none
CRITICAL
From Schauer, 2014 <6% Glycated Hemoglobin (follow up: mean 3 years; assessed with: Prevalence)
1
randomised
trials
not
serious
not serious
not serious
serious
1
From Schauer 2014, Anemia (follow up: median 3 years; assessed with: Prevalence)
1
randomised
trials
not
serious
not serious
not serious
serious
Frpm Schauer, 2014 Weight (follow up: mean 2 years; assessed with: Kg)
1
randomised
trials
not
serious
not serious
not serious
serious
MD – mean difference, RR – relative risk
1. Small sample size wide confidence margins, impacting clinical decisions
References
1. Schauer P, Bhatt D, Kirwan J, Wolski K, Brethauer S, et al. Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 3-Year Outcomes. 2014. New England
Journal of Medicine. 370: 21: 2002-13
Management of Overweight and Obese
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121
Appendix 2: Search Strategies and Results
Benefits and Harms:
Search run November 21, 2014
Database: Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and
Ovid MEDLINE(R) <1946 to Present>
Search Strategy:
1 exp Obesity/ (154104)
2 Hyperphagia/ (2605)
3 (obes* or adipos* or overweight* or over weight*).ti,ab. (254304)
4 (overeat* or overfeed*).ti,ab. (3191)
5 weight-gain/ (24269)
6 Weight Loss/ (26666)
7 Body Mass Index/ (88597)
8 weight gain.ti,ab. (44380)
9 or/1-8 (381046)
10 exp Diet Therapy/ (44026)
11 exp Obesity/dh [Diet Therapy] (6449)
12 (low calorie or calorie control$ or healthy eating).tw. (5780)
13 ((diet or diets or dieting) adj2 (loss or lose or weight or obesity or obese)).mp. [mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier]
(9953)
14 or/10-13 (58501)
15 exp Exercise/ (127556)
16 exp Exercise Therapy/ (32405)
17 exp Exercise Movement Techniques/ (5595)
18 exercis*.mp. (270064)
19 (aerobics or physical therapy or physical activity or physical inactivity).tw. (76660)
20 (fitness adj3 (class$ or regime$ or program$)).tw. (1190)
21 exp "Physical Education and Training"/ (13771)
22 physical education.mp. (13637)
23 (dance or dancing).mp. [mp=title, abstract, original title, name of substance word, subject
heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier] (4407)
24 physical activity.mp. (62934)
25 or/15-24 (363369)
26 14 or 25 (413444)
27 life style/ or sedentary lifestyle/ (48434)
28 sedentary behavio?r.tw. (1830)
29 ((lifestyle or life style) adj (chang$ or intervention$)).tw. (8736)
30 counseling/ or directive counseling/ (30736)
31 counsel?ing.tw. (64083)
32 social support/ (54365)
33 (peer adj2 support).tw. (2131)
34 exp Behavior Therapy/ (56285)
35 ((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).tw. (26773)
36 exp Obesity/rh, th [Rehabilitation, Therapy] (14366)
37 or/27-36 (259339)
Management of Overweight and Obese
Adults
122
38 26 or 37 (636831)
39 9 and 38 (80051)
40 meta-analysis/ (54577)
41 meta-analysis as topic/ (14592)
42 (meta analy* or metanaly* or metaanaly*).ti,ab. (73428)
43 (reference list* or bibliograph* or hand search* or manual search* or relevant journals).ab.
(28234)
44 ((systematic* or evidence*) adj2 (review* or overview*)).ti,ab. (85108)
45 (search strategy or search criteria or systematic search or study selection or data extraction).ab. (30566)
46 (search* adj4 literature).ab. (30815)
47 (medline or pubmed or cochrane or embase or psychlit or psyclit or psychinfo or psycinfo or
cinahl or science citation index or bids or cancerlit).ab. (103980)
48 cochrane.jw. (11918)
49 or/40-48 (226698)
50 randomized controlled trial.pt. (400170)
51 controlled clinical trial.pt. (90682)
52 randomi#ed.ab. (382015)
53 placebo.ab. (163764)
54 randomly.ab. (228711)
55 Clinical Trials as topic.sh. (176359)
56 trial.ti. (138819)
57 or/50-56 (984722)
58 49 or 57 (1148705)
59 39 and 58 (14174)
60 limit 39 to ("reviews (best balance of sensitivity and specificity)" or "therapy (best balance of
sensitivity and specificity)") (21915)
61 59 or 60 (24709)
62 limit 61 to yr="2011 -Current" (7791)
Records Retrieved
Pharmacological
Non-pharmacological
Summary of Searches
Total No. Retrieved: 3756
Medline:
3756
Duplicates:
488
No. Total
3268
without duplicates:
Screening (Title and Abstract Review)
No. Excluded:
2363
Included for Full Text 3
review:
Selection (Full Text Review)
No. Excluded:
0
3756
129
3627
Management of Overweight and Obese
Adults
123
Patients’ Values and Preferences:
Search run November 30, 2014
Database: MEDLINE, EMBASE, PsychInfo
Search Strategy:
1 exp Obesity/ (154152)
2 Hyperphagia/ (2605)
3 (obes* or adipos* or overweight* or over weight*).ti,ab. (254449)
4 (overeat* or overfeed*).ti,ab. (3191)
5 weight-gain/ (24275)
6 Weight Loss/ (26674)
7 Body Mass Index/ (88624)
8 weight gain.ti,ab. (44396)
9 or/1-8 (381220)
10 patient$ participation.mp. or exp patient participation/ (20206)
11 patient$ satisfaction.mp. or exp patient satisfaction/ (77077)
12 attitude to health.mp. or exp Attitude to health/ (387184)
13 (patient$ preference$ or patient$ perception$ or patient$ decision$ or patient$ perspective$
or user$ view$ or patient$ view$ or patient$ value$).mp. (25842)
14 (patient$ utilit$ or health utilit$).mp. (1464)
15 health related quality of life.mp. or exp "quality of life"/ (131808)
16 (health stat$ utilit$ or health stat$ indicator$ or (health stat$ adj 2 valu$)).mp. or exp Health
Status Indicators/ (210575)
17 10 or 11 or 12 or 13 or 14 or 15 or 16 (704450)
18 9 and 17 (20525)
19 Saudi Arab$.mp,in. or Saudi Arabia/ (31680)
20 Riyadh.mp,in. (16650)
21 Jeddah.mp,in. (3860)
22 Kh*bar.mp,in. (775)
23 Dammam.mp,in. (1390)
24 19 or 20 or 21 or 22 or 23 (32156)
25 Kuwait$.mp,in. or Kuwait/ (7020)
26 United Arab Emirates.mp,in. or United Arab Emirates/ (4566)
27 Qatar$.mp,in. or Qatar/ (2575)
28 Oman$.mp,in. or Oman/ (3981)
29 Yemen$.mp,in. or Yemen/ (1939)
30 Bahr*in$.mp,in. or Bahrain/ (1275)
31 25 or 26 or 27 or 28 or 29 or 30 (20491)
32 Middle East$.mp,in. or Middle East/ (12125)
33 Jordan$.mp,in. or Jordan/ (10518)
34 Libya$.mp,in. or Libya/ (1867)
35 Egypt$.mp,in. or Egypt/ (39361)
36 Syria$.mp,in. or Syria/ (10926)
37 Iraq$/ or Iraq.mp,in. (8291)
38 Morocc$.mp,in. or Morocco/ (8762)
39 Tunisia$.mp,in. or Tunisia/ (12985)
40 Leban$.mp,in. or Lebanon/ (15544)
41 West Bank.mp,in. (771)
42 Iran$.mp,in. or Iran/ (67613)
43 Turkey/ or (Turkey or Turkish).mp,in. (155414)
Management of Overweight and Obese
Adults
44
45
46
47
48
49
Algeria$.mp,in. or Algeria/ (4354)
Arab$.mp,in. or Arabs/ (125650)
32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 (337727)
45 or 46 (454438)
24 or 31 or 47 (467162)
18 and 48 (589)
Summary of Searches:
Total No. Retrieved: 2625
Medline
589
PsychInfo
25
EMBASE
2011
Duplicates:
367
No. Total
2258
without duplicates:
Screening (Title and Abstract Review)
No. Excluded:
2255
Included for Full Text 2
review:
Selection (Full Text Review)
No. Excluded:
0
124
Management of Overweight and Obese
Adults
125
Cost-Effectiveness Search:
Search run November 30, 2014
Database: MEDLINE, EMBASE
Search Strategy:
1 Socioeconomics/ (110868)
2 Cost benefit analysis/ (65601)
3 Cost effectiveness analysis/ (101296)
4 Cost of illness/ (14509)
5 Cost control/ (50040)
6 Economic aspect/ (103874)
7 Financial management/ (101549)
8 Health care cost/ (132593)
9 Health care financing/ (11523)
10 Health economics/ (33932)
11 Hospital cost/ (14232)
12 (fiscal or financial or finance or funding).tw. (109404)
13 Cost minimization analysis/ (2558)
14 (cost adj estimate$).mp. (2092)
15 (cost adj variable$).mp. (170)
16 (unit adj cost$).mp. (2617)
17 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 (679512)
18 exp obesity/ (308984)
19 hyperphagia/ (3887)
20 (obes* or adipos* or overweight* or over weight*).ti,ab. (322118)
21 (overeat* or overfeed*).ti,ab. (3720)
22 weight gain/ (67531)
23 weight reduction/ (103657)
24 body mass/ (197803)
25 (weight adj (gain or loss)).ti,ab. (129150)
26 or/18-25 (662336)
27 exp diet therapy/ (248469)
28 exp obesity/rh, th [Rehabilitation, Therapy] (16893)
29 (low calorie or calorie control$ or healthy eating).tw. (7104)
30 ((diet or diets or dieting) adj2 (loss or lose or weight or obesity or obese)).mp. (30967)
31 or/27-30 (285461)
32 exp exercise/ (218192)
33 exp kinesiotherapy/ (49594)
34 Exercis*.mp. (356633)
35 (aerobics or physical therapy or physical activity or physical inactivity).tw. (94257)
36 (fitness adj3 (class$ or regime$ or program$)).tw. (1460)
37 physical education/ (10177)
38 (dance or dancing).mp. (5615)
39 physical activity.mp. (113171)
40 or/32-39 (476742)
41 31 or 40 (725549)
42 "lifestyle and related phenomena"/ or lifestyle/ or lifestyle modification/ or sedentary lifestyle/
(98349)
43 sedentary behavio?r.tw. (1998)
44 ((lifestyle or life style) adj (chang$ or intervention$)).tw. (11717)
Management of Overweight and Obese
Adults
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
126
counseling/ or directive counseling/ or nutritional counseling/ (43798)
counsel?ing.tw. (80945)
social support/ (59003)
(peer adj2 support).tw. (2745)
exp psychotherapy/ (191443)
((psychological or behavio?r$) adj (therapy or modif$ or strateg$ or intervention$)).tw. (35097)
or/42-50 (441962)
41 or 51 (1101038)
26 and 52 (171741)
limit 53 to "reviews (maximizes specificity)" (2220)
limit 54 to yr="2011 -Current" (1399)
limit 53 to "therapy (maximizes specificity)" (5764)
limit 56 to yr="2011 -Current" (2384)
55 or 57 (3673)
17 and 53 (8177)
Saudi Arab$.mp,in. or Saudi Arabia/ (49446)
Riyadh.mp,in. (26759)
Jeddah.mp,in. (6984)
Kh*bar.mp,in. (1268)
Dammam.mp,in. (2016)
60 or 61 or 62 or 63 or 64 (49745)
Kuwait$.mp,in. or Kuwait/ (11086)
United Arab Emirates.mp,in. or United Arab Emirates/ (9987)
Qatar$.mp,in. or Qatar/ (4944)
Oman$.mp,in. or Oman/ (5662)
Yemen$.mp,in. or Yemen/ (2613)
Bahr*in$.mp,in. or Bahrain/ (3102)
66 or 67 or 68 or 69 or 70 or 71 (35343)
Middle East$.mp,in. or Middle East/ (15410)
Jordan$.mp,in. or Jordan/ (30783)
Libya$.mp,in. or Libya/ (3031)
Egypt$.mp,in. or Egypt/ (69887)
Syria$.mp,in. or Syria/ (16213)
Iraq$/ or Iraq.mp,in. (10495)
Morocc$.mp,in. or Morocco/ (18780)
Tunisia$.mp,in. or Tunisia/ (25366)
Leban$.mp,in. or Lebanon/ (27300)
West Bank.mp,in. (1106)
Iran$.mp,in. or Iran/ (111983)
Turkey/ or (Turkey or Turkish).mp,in. (257793)
Algeria$.mp,in. or Algeria/ (8090)
Arab$.mp,in. or Arabs/ (158448)
73 or 74 or 75 or 76 or 77 or 78 or 79 or 80 or 81 or 82 or 83 or 84 or 85 (577872)
86 or 87 (714548)
65 or 72 or 88 (733973)
59 and 89 (287)
Management of Overweight and Obese
Adults
Summary of Searches:
Total No. Retrieved: 391
Medline
104
EMBASE
287
Duplicates:
50
No. Total
341
without duplicates:
Screening (Title and Abstract Review)
No. Excluded:
339
Included for Full Text 2
review:
Selection (Full Text Review)
No. Excluded:
0
127