Multiple Behavioral Risk Factor Interventions in
Primary Care
Summary of Research Evidence
Michael G. Goldstein, MD, Evelyn P. Whitlock, MD, MPH, Judith DePue, EdD, MPH,
Planning Committee of the Addressing Multiple Behavioral Risk Factors in Primary Care Project
Background: An important barrier to the delivery of health behavior change interventions in primary
care settings is the lack of an integrated screening and intervention approach that can cut
across multiple risk factors and help clinicians and patients to address these risks in an
efficient and productive manner.
Methods:
We review the evidence for interventions that separately address lack of physical activity, an
unhealthy diet, obesity, cigarette smoking, and risky/harmful alcohol use, and evidence for
interventions that address multiple behavioral risks drawn primarily from the cardiovascular and diabetes literature.
Results:
There is evidence for the efficacy of interventions to reduce smoking and risky/harmful
alcohol use in unselected patients, and evidence for the efficacy of medium- to highintensity dietary counseling by specially trained clinicians in high-risk patients. There is fair
to good evidence for moderate, sustained weight loss in obese patients receiving highintensity counseling, but insufficient evidence regarding weight loss interventions in
nonobese adults. Evidence for the efficacy of physical activity interventions is limited. Large
gaps remain in our knowledge about the efficacy of interventions to address multiple
behavioral risk factors in primary care.
Conclusions: We derive several principles and strategies for delivering behavioral risk factor interventions in primary care from the research literature. These principles can be linked to the
“5A’s” construct (assess, advise, agree, assist, and arrange-follow up) to provide a unifying
conceptual framework for describing, delivering, and evaluating health behavioral counseling interventions in primary healthcare settings. We also provide recommendations for
future research.
(Am J Prev Med 2004;27(2S):61–79) © 2004 American Journal of Preventive Medicine
Introduction
L
ack of regular physical activity, an unhealthy
diet, smoking, and alcohol misuse are leading
causes of disease, death, and loss of functioning.1,2 Healthy People 2010 has designated tobacco use,
physical activity, substance abuse, and overweight/obesity as four of the leading health indicators that will be
closely monitored to reflect the health of the United
States.1
Primary care clinicians have the potential to play an
important role in addressing these key behavioral risk
From the Bayer Institute for Health Care Communication (Goldstein), West Haven, Connecticut; Oregon Health and Science University Evidence-Based Practice Center, Kaiser Permanente/Center
for Health Research (Whitlock), Portland, Oregon; Centers for
Behavioral and Preventive Medicine, Brown Medical School (DePue,
Goldstein), and The Miriam Hospital, Providence, Rhode Island
Address correspondence to: Michael G. Goldstein, MD, Bayer
Institute for Health Care Communication, 400 Morgan Lane, West
Haven CT 06516. E-mail: [email protected].
factors in the general population. For example, data
from the 2000 –2001 U.S. National Health Interview
Survey indicate that 83% of the adults aged 18 to 64
years report that they have a usual source of care, a
place where they usually go when they are “sick or ...
need advice about health.”3 Moreover, the longitudinal
nature of primary care provides multiple opportunities
for clinicians to provide health behavior advice and
counseling over long periods of time. According to
recent data from a national sample of patients, ⬎40%
of patients aged ⬎40 have had the same doctor for ⬎5
years.4 Because a majority of adults in the United States
have at least two of the four leading risk behaviors (see
articles in this supplement by Fine et al.5 and Coups et
al.6), strategies for addressing multiple risk behaviors
within primary care settings are clearly needed. However, an important barrier to the delivery of health
behavior change interventions in primary care settings
is the lack of an integrated screening and intervention
approach that can cut across multiple risk factors and
Am J Prev Med 2004;27(2S)
© 2004 American Journal of Preventive Medicine • Published by Elsevier Inc.
0749-3797/04/$–see front matter
doi:10.1016/j.amepre.2004.04.023
61
help clinicians and patients to address these risks in an
efficient and productive manner.7,8
Although there is increasing evidence for the effectiveness of brief primary care– based interventions for
changing individual health risk behaviors (e.g., tobacco
use, risky drinking),9 few research trials in primary care
settings have attempted to address multiple behavioral
risk factors in a single intervention.10 In this paper, we
will first review the evidence for interventions that
separately address these four health behaviors in primary care settings. Then, because of the dearth of
research evidence on multiple behavioral risk factor
interventions in general populations of patients, we will
review evidence for interventions that address multiple
behavioral risks drawn primarily from the cardiovascular and diabetes literature. This is followed by suggestions for principles for delivering multiple behavioral
risk factor interventions in primary care settings based
on extrapolations from single risk factor evidence, the
limited evidence from multiple behavioral risk factor
interventions and other current data. We conclude with
recommendations for future research.
What Do We Know About Single Behavioral Risk
Factor Interventions in Primary Care?
The United States Preventive Services Task Force
(USPSTF), which relies on rigorous systematic evidence
reviews demonstrating high-quality evidence of clinically significant benefits on health outcomes to recommend clinical preventive services,11 has recently published revised recommendations and associated
systematic reviews addressing physical activity,12,13 dietary counseling,14,15 obesity,16,17 smoking,18 and risky
and harmful drinking.19,20 To address smoking, we also
utilized the Clinical Practice Guideline for Treating Tobacco
Use and Dependence, published by the U.S. Public Health
Service (PHS) in 2000.21
To complement the evidence gathered by the
USPSTF and PHS, we have also reviewed evidencebased recommendations for population-based health
activities, including environmental and health system
interventions, for these behaviors from the Task Force
on Community Preventive Services (Community Task
Force) Guide to Community Preventive Services: Systematic
Reviews and Evidence-Based Recommendations.22 Although
Community Task Force recommendations are based on
systematic reviews of research evidence from interventions outside the realm of primary care, these community-based interventions can complement, extend, and
even support primary care interventions.7,23,24 Evidence reviews and the associated recommendations by
the Community Task Force for addressing tobacco
control and physical activity have been published.25,26
The reviews and recommendations for communitybased dietary improvement are expected in 2004 while
the Community Task Force systematic review and rec62
ommendations for alcohol use and abuse are expected
at a later date.
Physical Activity
In August 2002, the USPSTF found insufficient evidence (an “I” recommendation) to recommend for or
against behavioral counseling in primary care settings
to promote physical activity (Table 1).13 The USPTF
evidence-based review that generated this recommendation included controlled trials and observational
studies in which; (1) a primary care clinician performed some of the counseling intervention; (2) physical activity outcomes were reported; and (3) the study
was of “good” or “fair” quality, according to criteria
developed by the USPSTF.12 Eight trials involving 9054
adults met inclusion criteria.12 The “I” recommendation was based on the mixed quality of the reviewed
trials and the limited evidence for a sustained effect on
physical activity.12 Most of the studies reviewed by the
USPSTF reported nonsignificantly increased physical
activity outcomes in the intervention groups 6 to 24
months after follow-up. Most of these studies compared
brief, minimal, and low-intensity interventions, such as
3 to 5 minutes of counseling in the context of a routine
clinical visit, with or without short-term follow-up mailings, telephone calls, or visits with usual care controls.
The Community Task Force has strongly recommended several evidence-based strategies to increase
physical activity.25 Members reviewed three broad approaches to increasing physical activity: (1) informational approaches to change knowledge and attitudes
about the benefits of and opportunities for physical
activity; (2) environmental and policy approaches to
change the structure of physical and organizational
environments to provide safe, attractive, and convenient places for physical activity; and (3) behavioral and
social approaches to assist individuals to adopt and
maintain increased physical activity.25,27 The authors of
the Community Task Force review found two informational approaches, one environmental and policy approach and three behavioral and social approaches to
be effective.27 Within the category of behavioral and
social support approaches, the Community Task Force
strongly recommended tailoring behavioral interventions to the individual’s specific interests, preferences,
and readiness for change and strategies to build community-based social support for physical activity.25,27
Programs that were effective in producing positive
physical activity outcomes (i.e., time spent in physical
activity, energy expenditure, or aerobic capacity) incorporated the following behavioral approaches: (1) goal
setting for physical activity and self-monitoring of
progress toward goals; (2) garnering social support for
new physical activities; (3) self-reward and positive
self-talk to reinforce physical activity; (4) structured
problem solving to help maintain increased physical
American Journal of Preventive Medicine, Volume 27, Number 2S
Table 1. Evidence linking single health risk behavior counseling to health behavior change
Behavior
Regular physical
activity
Healthy diet
Obesity
U.S. Preventive Services Task
Force recommended gradea
Community Task Force
recommendation
I
Behavioral counseling in primary
care to promote physical
activity: recommendation and
rationale. Ann Intern Med
2002;137:205–207.
Evidence review: Eden KB, et al.,
Does counseling by clinicians
improve physical activity? A
summary of the evidence for
the U.S. Preventive Services
Task Force. Ann Intern Med
2002;137:208–15.
B
(Specially trained providers)
I
(Primary care providers)
Behavioral counseling in primary
care to promote a healthy diet:
recommendation and
rationale. Am J Prev Med
2003;24:93–100.
Evidence review: Pignone MP, et
al., Counseling to promote a
healthy diet in adults: a
summary of the evidence for
the U.S. Preventive Services
Task Force. Am J Prev Med
2003;24:75–92.
B
(Screening and offering
intensive counseling and
behavioral intervention to
obese adults)
I
(Moderate or low intensity
counseling and behavioral
intervention for obese adults)
I
(Counseling for overweight
adults)
Screening for obesity in adults:
recommendations and
rationale. Ann Intern Med
2003;139:930–2
Evidence review: McTigue KM, et
al., Screening and
interventions for obesity in
adults: summary of the
evidence for the U.S.
Preventive Services Task Force.
Ann Intern Med 2003;139:933–
49.
Strongly recommended:
Individually adapted programs
Nonfamily social support
Tailor intervention to individual’s
interests, preferences, and
readiness
Effective interventions included:
Goal setting with self-monitoring
Social support for new activities
Reinforcement through selfreward
Structured problem solving
Recommendation expected in
2004
Intensity of intervention related to
outcome
Most studies of specialty-trained
providers had a moderate level
of intervention intensity
(multiple intervention contacts,
but fewer than six, generally
⬍30 minutes per contact)
Use of self-help materials, tailored
mailings, and telephone
counseling along with brief
provider advice were moderately
effective
No recommendation
Body mass index is reliable and
valid for identifying individuals
at increased risk
Fair to good evidence that high
intensity counseling with
behavioral interventions
produces sustained weight loss
in obese individuals
High intensity ⫽ more than one
session per month for at least 3
months
Effective interventions targeted
both diet and physical activity
and included elements that
addressed skill development,
motivation, and support
Pharmacologic interventions can
produce modest weight loss;
should only be used as part of a
program that includes
behavioral intervention
Surgical interventions should be
reserved for those with Class III
obesity
Opportunity for primary care
(continued on next page)
activity; and (5) strategies to prevent relapse to less
activity.27
Healthy Diet
In January 2003, the USPSTF found insufficient evidence (an “I” recommendation) to recommend for or
against behavioral counseling to promote a healthy diet
in unselected patients in primary care settings (Table
1). According to USPSTF standards,11 there was fair
evidence that brief low- to medium-intensity (single or
limited multiple contacts lasting ⬍30 minutes) dietary
counseling in primary care produces small to medium
Am J Prev Med 2004;27(2S)
63
Table 1. (continued)
Behavior
Preventing/ceasing
tobacco use
Risky/harmful
alcohol use
U.S. Preventive Services Task
Force recommended gradea
A
Counseling to prevent tobacco
use and tobacco-caused
disease: recommendation
statement. Agency for
Healthcare Research and
Quality, 2003. Rockville MD.
Evidence review: Fiore MC, et al.
Treating tobacco use and
dependence: clinical practice
guideline. Rockville MD: U.S.
Department of Health and
Human Services, Public Health
Service, 2000.
B
(Screening and behavioral
counseling interventions)
Screening and behavioral
counseling interventions in
primary care to reduce alcohol
misuse: recommendation
statement. Ann Intern Med
2004;140:554–6
Evidence review: Whitlock EP, et
al., Behavioral counseling
interventions in primary care
to reduce risky/harmful
alcohol use by adults: a
summary of the evidence for
the U.S. Preventive Services
Task Force. Ann Intern Med
2004;140:557–68.
Community Task Force
recommendation
Strongly recommended:
System interventions to assist
primary care providers
Telephone cessation support
Smoking restrictions
Reducing patient costs for
cessation aids
No recommendation
Opportunity for primary care
Screening of tobacco use is
essential
Brief 1–3 minutes of advice to quit
Effective pharmacotherapies
Greater-intensity interventions
should be offered when possible
Problem-solving, intratreatment
support, accessing social support
are effective intervention
strategies
Screening can accurately identify
patients whose levels of alcohol
use place them at risk for
increased morbidity and
mortality
Brief 15-minute counseling
interventions and follow-up
produce sustained small to
moderate reductions in
hazardous drinking
Effective interventions include
feedback, advice, goal setting,
and follow-up
Note: This table was adapted with permission from Whitlock, EP and Williams, SB. The primary prevention of heart disease in women through
health behavior change promotion in primary care, Womens Health Issues 2003;13:122– 41.
a
Key to grade: A, strongly recommends; B, recommends; C, no recommendation for or against; D, recommends against routine provision to
asymptomatic patients; and I, insufficient evidence.
changes in self-reported dietary components. However,
because this evidence is limited by reliance on selfreported diet outcomes, limited use of corroborating
measures, limited follow-up data beyond 6 to 12
months, and enrollment of study participants who
might not be representative of primary care patients,
the USPSTF judged this evidence insufficient to determine the magnitude of benefit or the clinical significance of these changes.15
On the other hand, based on good evidence by its
standards, the USPSTF gave a “B” recommendation for
intensive behavioral dietary counseling for adult patients at high risk (i.e., patients with hyperlipidemia or
other known risk factors for cardiovascular or other
diet-related chronic disease).15 The USPSTF specified
that intensive intervention could be delivered by specially trained primary care clinicians or other specialists
(e.g., nutritionists, dietitians, health educators).15 The
systematic evidence review on which the USPSTF based
these recommendations identified 21 trials that met its
inclusion criteria (i.e., randomized controlled trials of
64
ⱖ3 months’ duration with measures of dietary behavior
that were conducted in patient populations similar to
those found in primary care practices).14
Studies that specifically recruited patients with
chronic illnesses (e.g., heart disease, diabetes) or that
required special diets were excluded, although studies
that enrolled patients with known risk factors (e.g.,
elevated cholesterol, hypertension, obesity) were included. This review found good evidence that mediumto high-intensity counseling interventions produced
medium or large changes in average daily intake of
saturated fat, fiber, and fruits and vegetables among
high-risk patients.14 Moreover, higher-intensity interventions produced larger effects than studies using
brief interventions.14 However, most of the studies
using specialty-trained clinicians with high-risk patients
actually had only a medium level of intervention intensity (i.e., between two and five) intervention contacts,
with generally ⬍30 minutes per contact).14 Because
higher-intensity interventions were usually delivered in
trials that utilized special research clinics and subjects
American Journal of Preventive Medicine, Volume 27, Number 2S
who were selected because they were at risk for disease,
the larger effects seen in these trials may have been
related to selection bias. That is, subjects who agreed to
participate in such trials may have been more motivated
and thereby more likely to respond to the intervention
than unselected patients who are offered an intervention within primary care settings.28 The USPSTF review
panel partially addressed this limitation by conducting
an analysis that explored the relationship between the
risk status of the patients and the effect size achieved.
After stratifying by intervention intensity, there was no
clear relationship between patient risk status and the
effect size achieved.14 However, other differences in the
representativeness of the samples across the studies
(e.g., motivation, willingness to be randomized to an
intensive intervention condition) were not addressed in
these analyses.
In a more comprehensive report on the effects of
dietary counseling, the USPSTF panel identified the
following components of dietary counseling that are
associated with improved behavioral outcomes: using a
dietary assessment, enlisting family involvement, providing social support, using group counseling, emphasizing food interaction, encouraging goal setting, and
using advice tailored to the patient group being studied.29 Interventions including a greater number of
these components have larger effects than those with
fewer components, while interventions that added selfhelp materials and interactive communications (e.g.,
computer-generated tailored reports, telephone counseling) to brief provider advice produced “medium”
effects.29 Two approaches were judged to be especially
promising by the USPSTF: (1) medium-intensity faceto-face dietary counseling delivered by a specially
trained clinician; and (2) low-intensity brief counseling
(⬍5 minutes) supplemented by self-help materials,
follow-up telephone counseling, or other interactive
health communications.15 The latter approach to intervention was judged to be most feasible in primary care
settings when system supports for their delivery are
available.14 The medium intensity intervention would
require either dissemination of training to develop the
counseling skills of the primary care clinician or an
effective hand-off between the primary care team and
another specially trained clinician (e.g., dietitian,
health educator, specially trained nurse).
Obesity
The USPSTF evidence-based review and recommendations on counseling to promote a healthy diet, discussed in the section above, excluded nutritional counseling that focused primarily on weight loss, weight
maintenance, or obesity.14 Subsequently, in late 2003,
the USPSTF recommended that clinicians screen all
adult patients for obesity using body mass index (BMI)
measurement and offer intensive counseling and be-
havioral interventions for those screening as obese
(BMI⬎30kg/m2) (a “B” recommendation)17 (Table 1).
The recommendation for screening was based on the
USPSTF’s conclusion that there was good evidence that
BMI, calculated as weight in kilograms divided by
height in meters squared, validly and reliably identifies
adults with increased risk for morbidity and mortality
due to excess weight.16,17 The USPSTF’s recommendation to offer intensive intervention was based on finding fair-to-good evidence for moderate, sustained
weight loss in obese patients receiving high-intensity
counseling that addressed physical activity, dietary improvement, or both, in combination with behavioral
intervention strategies to develop skills and motivations, and provide support.16,17 On the other hand, the
USPSTF found insufficient evidence (an “I” recommendation) to recommend for or against low- or moderateintensity counseling and behavioral interventions, and
insufficient evidence (an “I” recommendation) regarding weight loss and maintenance following counseling
and behavioral interventions of any intensity in adult
patients who are overweight but not obese (BMI of 25
to 29.9 kg/m2).16,17
The systematic evidence review on which the USPSTF
based its recommendations16 identified three prior
well-done systematic reviews of counseling and behavioral interventions that reported on net mean weight
change at 12 months (intervention minus control). The
U.S. National Institutes of Health Review found a net
mean weight change of ⫺3.3 kg (range 1.9 to ⫺8.8) for
the 29 randomized controlled trials (RCTs) they reviewed, and also established that modest counselingassociated weight loss of 5 to 10 kg could improve blood
pressure, glycemic control, and serum lipid levels.30
The United Kingdom National Health Service review
found a net mean weight change of ⫺3.0 kg (range 1.4
to ⫺10.6) for 24 RCTs over 12 to 60 months.31 In a
smaller review of six RCTs, the Canadian Task Force on
Preventive Health Care found a net weight change of
⫺.2.1 kg (range ⫺0.2 to ⫺4.5) after 24 to 84 months.32
In addition, the systematic review conducted for the
USPSTF identified 17 additional RCTs of high-intensity
(more than monthly person-to-person contact in the
first 3 intervention months), medium-intensity
(monthly contact in the first 3 months), or low-intensity
intervention (less than monthly interpersonal contact
in the first 3 months).16 The most effective interventions were of high intensity and combined two to three
components (nutrition education, diet and exercise
counseling, behavioral strategies) to achieve weight loss
of 3 to 5 kg at 1 year.16
Smoking
Clinician counseling of all patients to reduce or stop
the use of tobacco products was the only primary-care
counseling service given an “A” recommendation by
Am J Prev Med 2004;27(2S)
65
the USPSTF in 1996.33 In June 2000, the PHS strongly
recommended clinician counseling for smoking cessation in its revised Clinical Practice Guideline for Treating
Tobacco Use and Dependence (PHS Guideline).21 The PHS
Guideline was cited as evidence for the USPSTF’s
recently updated “A” recommendation for tobacco use
screening and intervention in primary care.18 The PHS
Guideline Panel and the USPSTF based their recommendations on evidence that minimal advice or counseling (ⱖ1 to 3 minutes of person-to-person contact in
a single session) significantly increases abstinence
rates.21 Moreover, across 43 trials included in a PHS
Guideline meta-analysis, there was a dose–response
relationship between the intensity of smoking cessation
intervention and smoking-cessation outcome.21 Thus,
more intensive interventions (total contact of 30 to 90
minutes over two to eight contacts) are recommended
for those patients who are willing to commit to intensive treatment. However, because only a small percentage of smokers are willing to accept intensive smokingcessation treatment,34 brief primary care– based
interventions have the potential to reach and assist a
much larger proportion of smokers.35
Behavioral problem solving, assisting the patient to
access social support, and providing the support element within the context of treatment were identified as
effective intervention elements by the PHS Guideline
panel.21 The PHS Guideline also recommended that
clinicians offer effective pharmacotherapies (sustainedrelease bupropion or nicotine replacement therapy)
for those patients attempting to quit, except when
contraindicated.21 Also, interventions that are provided
through three or four different formats (i.e., self-help,
proactive telephone counseling, group counseling, and
individual counseling) have higher abstinence rates
than those limited to one format. The involvement of
more than one provider in the delivery of interventions
(e.g., physician and nurse) was associated with higher
abstinence rates than interventions delivered by a single clinician, although this was a nonsignificant trend.21
The Community Task Force Guide to Community
Preventive Services has strongly recommended two
healthcare system interventions to increase or improve
the delivery of smoking-cessation interventions in primary care: (1) Multicomponent systems that identify
smokers, remind providers to intervene, provide access
to patient educational materials, and train providers to
both identify and counsel smokers; and (2) Telephone
support to provide tobacco users with follow-up counseling in addition to other proven interventions.36 The
PHS Guideline, the USPSTF, and the Community Task
Force all strongly recommend that healthcare organizations adopt systems to support primary care– based
assessment, advice, and brief counseling, as well as systems
to link the primary care setting with community-based
resources that might provide educational materials, follow-up counseling, and more intensive treatment, when
66
desired. The Community Task Force also recommended
reducing patient out-of-pocket costs for effective cessation therapies, as this has been shown to increase the
use of these recommended therapies and to increase
the total number of tobacco-using patients who quit.26
Risky/Harmful Drinking
In 1996, the USPSTF recommended screening for
problem drinking (a “B” recommendation),33 and this
recommendation was updated in 2004 to also recommend brief multicontact primary care interventions for
risky and harmful drinkers who are identified through
screening.19 The USPSTF found good evidence that
screening in primary care settings can accurately identify patients whose levels or patterns of alcohol consumption do not meet criteria for alcohol dependence,
but place them at risk for increased morbidity and
mortality.19 This evidence included three good-quality
systematic reviews of screening37–39 and two goodquality nonsystematic reviews.40,41 These reviews are
examined in more detail elsewhere.42 Strategies for
screening for alcohol misuse are discussed in the paper
by Babor et al. in this supplement.43
The 2004 systematic review of behavioral counseling
interventions that supported the new USPSTF recommendations considered 15 intervention conditions tested
in 12 trials of brief primary care– based interventions for
risky (hazardous) and harmful drinking.20 The authors of
the review found that brief multicontact interventions
(those with ⱕ15 minutes of initial contact and at least
one follow-up) significantly reduced average drinks per
week and increased the proportion drinking at moderate levels at 6 to 12 months of follow-up.20 Compared
with control participants, intervention participants reduced their weekly drinking by 13% to 34%, and 10%
to 19% more intervention participants reported moderate drinking patterns at follow-up.20 Results for trials
testing briefer interventions (ⱕ15 minutes of initial
contact without any follow-up) tended to favor intervention conditions over controls, but were not generally statistically significant.20 All interventions with statistically significant improvements in alcohol outcomes
had at least two of the following key intervention
elements: feedback, advice, and goal setting.20
The findings in the USPSTF systematic review were
supported by a meta-analysis, conducted by Moyer et
al.,44 that found that brief interventions were especially
effective for those patients with less severe drinking
problems. The Moyer meta-analysis also found evidence for the efficacy of brief intervention in the subset
of studies (n ⫽34) that identified subjects by “opportunistic” screening in primary care or emergency department settings.44 The USPSTF recommendations are
also generally consistent with a 2001 World Health
Organization report on brief medical care– based interventions for hazardous and harmful drinking.45
American Journal of Preventive Medicine, Volume 27, Number 2S
What Do We Know About Multiple Behavioral Risk
Factor Intervention Trials in Healthcare Settings?
In order to review evidence available for multiple
behavioral risk factor interventions in healthcare settings, we searched for systematic reviews published
between 1990 and the present (2004) in MEDLINE,
Cochrane Library, and the Database of Abstracts of
Reviews of Effects (DARE). Systematic reviews were
chosen because they generally define a systematic process for selection and evaluation of studies included,
with quality of the studies taken into account in conclusions. We used the following search terms: risk
factor, behavior risk, multiple risk factor, self-management, disease management, and health education.
These terms were also cross-referenced with key words
for two health conditions where multiple behavioral
risk factors are commonly considered: cardiovascular
disease and diabetes. Although we considered expanding our search to include other chronic conditions
(e.g., asthma, cancer prevention), we elected to limit
our search to cardiovascular disease and diabetes for
several reasons: (1) we were aware of several recently
published systematic reviews that addressed multiple
risk behaviors in the cardiovascular and diabetes literature; (2) we had difficulty identifying systematic reviews that addressed multiple risk behaviors for other
specific conditions; and (3) conducting a more exhaustive search was beyond the scope of this project. The
reference lists of retrieved reviews were also searched.
We found no reviews that were limited to primary care
settings. The reviews retrieved were further scanned for
inclusion of primary care settings in at least some of the
studies included. As a result, we excluded reviews that
were exclusively evaluating interventions in hospital,
rehabilitation, or community settings. We also excluded reviews that did not describe risk factor change
outcomes among the outcomes reported. Through this
process, we identified three systematic reviews for cardiovascular disease interventions,46 – 48 and three systematic reviews for diabetes interventions.49 –51 Since all
of these reviews included intervention settings outside
of primary care, we will focus on findings with greatest
relevance to primary care and we will highlight specific
studies that targeted multiple behavioral risk factors in
primary care settings.
Interventions to Address Multiple Behavioral
Risk Factors in Cardiovascular Disease
A systematic review of the effectiveness of interventions
targeting diet, physical activity, smoking cessation, and
alcohol intake in reducing cardiovascular disease was
published by Ketola et al. in 2000.47 The authors of this
review identified 21 multiple risk factor intervention
trials.52– 80 Ten of these were secondary prevention
studies (based on the presence of cardiovascular dis-
ease before the intervention)52– 62 and 11 were primary
prevention studies.63– 80 All studies were RCTs with
follow-up for ⱖ1 year (range, 1 to 10.5 years).47 Outcomes reported included cardiovascular morbidity and
mortality and change in risk factors. Among the eight
primary-prevention, multiple risk factor studies that
reported morbidity and mortality results,63– 67,69 –75,77–79
only two studies75,77 showed a significant effect on
morbidity, and none on mortality. Among the five
secondary prevention studies targeting multiple risk
behaviors and reporting morbidity and mortality results,52,53,57,60 – 62 two demonstrated effects on mortality53,60,61 and one on cardiovascular morbidity.62 When
both behavioral and physiologic (e.g., cholesterol,
blood pressure) risk factor change outcomes were
considered, both multiple risk primary prevention studies and multiple risk secondary prevention studies
produced significant changes, although primary prevention studies were less likely to produce clinically
significant change than secondary prevention trials.47
Significant changes in exercise,52,53,56 –58,60,76,77,80
weight,52,54,57,65,78,80 and smoking52,71,75 were noted for
both primary and secondary multiple risk factor prevention studies. One56 of three multiple risk secondary
prevention trials targeting risky alcohol drinking56,58,59
produced a significant reduction in alcohol consumption, while the only multiple risk primary prevention
trial targeting alcohol consumption77 did not have a
significant effect on this outcome. The authors of this
review47 conclude that multiple risk factor interventions should optimally be used for secondary prevention, rather than primary prevention, thus targeting
patients with existing cardiovascular disease or those at
high risk for cardiovascular disease (e.g., patients with
existing hypertension, diabetes, hyperlipidemia).
The authors of a recent Cochrane review of primary
prevention multiple risk factor intervention trials also
concluded that there was little evidence for a clinically
significant effect on cardiovascular disease outcomes.46
Physiologic risk factors (i.e., blood pressure and total
blood cholesterol) as well as behavioral risk factors were
included in this review. To meet inclusion criteria for
this review, trials had to have each of the following
elements: an RCT design; ⱖ6 months of follow-up;
participants aged ⱖ40 years old and without clinical
evidence of cardiovascular diseases; counseling or educational interventions, with or without pharmacologic
treatment, that targeted more than one risk factor (i.e.,
smoking, physical inactivity, diet, blood pressure and
total blood cholesterol); and outcomes that included
risk factor changes.46 Of the 18 trials that met these
eligibility criteria,52,58,63,64,66,72–76,81–92 ten reported
both disease events and risk factors and only four were
large enough to have sufficient power to demonstrate
meaningful changes in clinical events.46 Follow-up periods ranged from 6 months to 11.8 years. Pooled
effects across all studies revealed no effect on mortality
Am J Prev Med 2004;27(2S)
67
or cardiac events, although a small benefit of treatment
(about a 10% reduction in CHD mortality) may have
been missed due to limitations in power and in the
statistical approaches that were used.46 However, the
pooled effects of intervention on changes in both
behavioral and physiologic risk factors were significant,
although modest, and were related to the amount of
pharmacologic treatment (e.g., for hypertension or
hyperlipidemia) included in the intervention. However, there was also evidence for the effectiveness of
multiple risk factor counseling without pharmacologic
treatments when high-risk hypertensive populations
were targeted for intervention.46 In general, trials recruiting higher-risk individuals were more likely to
produce beneficial intervention effects.46
Results from PREMIER, a multicenter, multibehavioral risk factor intervention trial to address aboveoptimal blood pressure,93 were published in April 2003
and are not included in the Cochrane review. We have
elected to describe the results of this trial because it
meets the criteria for the Cochrane review and reports
important and relevant findings. PREMIER investigators randomized 810 adults with above-optimal blood
pressure (systolic 120 to 159 mm Hg and diastolic 80 to
95 mm Hg) to one of three conditions: (1) a behavioral
intervention condition, which consisted of four individual counseling sessions and 14 group meetings with an
“interventionist, typically a registered dietitian” to address weight, sodium intake, physical activity, and alcohol consumption; (2) the behavioral intervention plus
the Dietary Approaches to Stop Hypertension (DASH)
diet, which focused on adding increased consumption
of fruits and vegetables and low-fat dairy products and
decreased consumption of fat; and (3) an advice-only
condition, which consisted of a single 30-minute individual session with an interventionist.93 At the end of
the 6-month follow-up period, both behavioral interventions significantly reduced weight, lowered sodium
intake and improved fitness, and the behavioral intervention plus DASH condition also increased fruit,
vegetable, and low-fat dairy intake.93 Although all three
interventions produced reductions in blood pressure
and reductions in the prevalence of hypertension, both
behavioral interventions produced significantly greater
reductions in blood pressure than the advice-only
group.93
Additionally, at the end of the 6-month follow-up
period, the two behavioral interventions significantly
reduced the prevalence of both hypertension and
above-optimal blood pressure compared to advice
only.93 For example, 26% of the advice-only group was
hypertensive at the follow-up point compared to 17%
and 12% for the behavioral intervention and the behavioral intervention plus DASH groups, respectively.93
These changes in the prevalence and degree of hypertension, if sustained, would likely produce a substantial
reduction in cardiovascular disease risk.93 Although the
68
behavioral intervention plus DASH diet generally outperformed the behavioral intervention alone group,
these differences were not significant.93 The results of
the PREMIER trial extend the Cochrane review’s finding that multiple risk behavior interventions without
pharmacologic agents are efficacious when delivered to
hypertensive patients94 and to the broader population
of patients with suboptimal blood pressure.93
McAlister et al.48 reported results from a metaanalysis of 12 RCTs testing disease management interventions for coronary heart disease. The authors applied the following broad definition of disease
management: “a combination of patient education,
provider use of practice guidelines, appropriate consultation, and supplies of drugs and ancillary services.”
Studies were included in the meta-analyses if they met
the following criteria: were RCTs of interventions with
at least two modalities (e.g., exercise element, telephone follow-up); addressed patients with existing cardiac disease; enrolled ⱖ50 patients; and were not
inpatient based. All of the trials used a nurse or a
multidisciplinary clinical team to deliver an intervention that included patient education and counseling,
although the level and intensity of risk behavior counseling were not fully specified. The duration of the
interventions ranged from 0.5 to 48 months. Two53,95,96
of the 12 trials53,57,62,95–104 identified patients from
general practice settings, while the others recruited
patients soon after a hospitalization or a visit to a chest
pain clinic for a coronary artery disease episode or
event.
One additional trial101 recruited patients from a
hospital or chest pain clinic, but delivered a nurse-led
intervention that coordinated and supported care
within the primary care setting. Seven53,57,62,95–98,101 of
the 12 trials tracked and addressed multiple behavioral
risk factors, as well as physiologic risk factors (i.e. blood
pressure, cholesterol). Five57,62,95–98 of the seven, including one95,96 of the three primary care– based trials,
produced significantly greater improvements in risk
factors than usual care interventions.48 The primary
care– based study by Campbell et al.95 that was cited by
McAlister et al.48 as having positive risk factor outcomes
reported significant improvements in physical activity,
diet, blood pressure management, and lipid management, although no effect on smoking cessation. Moreover, a second primary care– based trial53 included in
the review produced significant improvements in exercise outcomes, although this finding was overlooked by
McAlister et al.48 More details regarding these two
primary care trials are provided below. Overall, across
all 12 studies, McAlister et al.48 found significant improvements in processes of care for disease management interventions, although the risk ratios derived
from the meta-analyses demonstrated no significant
effect on recurrent coronary events or mortality. In
summary, findings by McAlister et al.48 suggest that
American Journal of Preventive Medicine, Volume 27, Number 2S
nurse-led or multidisciplinary team–led secondary prevention programs that include multiple behavioral risk
factor interventions can produce positive changes in
behavioral risk factors, even when the intervention is
delivered in primary care settings.
As previously noted, few of the multiple health
behavior intervention trials reported in the three cardiovascular disease reviews46,47,48 were conducted in
primary care settings. However, two large primary care–
based primary prevention trials,63,76,105 and two primary care– based secondary prevention trials,53 all conducted in the United Kingdom, were included in the
reviews and are particularly relevant to this discussion.
Details regarding these four trials follow below.
The OXCHECK study was conducted in five urban
general practices the United Kingdom in the early
1990s.76,105 Final results (not included in the Ketola et
al.47 review) described outcomes for 4121 subjects
recruited from general primary-care practice registration lists and randomly allocated to an approximately
1-hour, nurse-led multiple risk factor counseling session and as needed follow-up or an assessment-only
control condition.105 All registered patients aged 35 to
64 were targeted for recruitment, irrespective of cardiovascular disease or risk status and 80% of eligible
patients were enrolled in the study.76 At the initial
health check intervention session, nurses assessed
smoking, diet, exercise, and alcohol consumption, and
provided counseling with an emphasis on ascertaining
the patient’s views on change and negotiating priorities
and targets for risk reduction.76 Except for standardized protocols for follow-up of hypertension and hyperlipidemia, follow-up was by mutual agreement, although nurses were encouraged to set their own
priorities in light of overall risk.76 After ⱖ3 years of
follow-up, mean serum total cholesterol was 3.1% lower
in the intervention group than in controls (difference
0.19 mmol/l; 95% confidence interval [CI]⫽0.12–
0.26); self-reported saturated fat intake was also significantly lower in the intervention group; and systolic and
diastolic blood pressures and body mass index were
respectively 1.9%, 1.9%, and 1.4% lower in the intervention group (p ⬍0.005 in all cases). There were no
significant differences in the number of individuals
with diastolic blood pressure ⬎100 mm Hg or BMI ⬎30
kg/m2 and there were no significant differences between the two groups in smoking cessation or change in
risky alcohol use. The authors concluded that the
benefits of health checks were sustained over 3 years,
but that the benefits of systematic health promotion in
primary care must be weighed against the costs in
relation to other priorities.105
The British Family Heart Study was an RCT of
nurse-led primary prevention screening and multiple
health behavior intervention in families of general
practices within 15 towns in Britain.63 The subjects were
recruited by approaching families of all men, aged 40
to 59, who appeared on practice lists. The true response
rate was 73%.63 Randomization of 12,472 subjects occurred at the practice level within towns. A second
control group was obtained through randomization
within intervention practices. Both patients in the
practice and a family member (i.e., partner) were
recruited into the trial. Research nurses were trained in
client-centered counseling techniques and provided all
elements of the intervention. The initial intervention
was conducted with the couple and took approximately
90 minutes. Subsequent follow-up was based on a
coronary risk score and occurred as frequently as every
2 months.
After 1 year, the cardiovascular risk factor score
(Dundee) was 16% lower in the intervention group
than in the control groups.63 The authors suggested
adjusting the reduction in risk score to 12% to take into
account those subjects who were lost to follow-up and
not included in the final analyses (12% to 15% of the
total sample).63 Change was greatest in those at the
highest level of risk at baseline. Reduction in individual
risk factors were quite modest in the intervention
compared to controls (4% lower smoking rate, 1 kg
mean weight reduction, 7 mm lower mean Hg systolic
pressure, 0.1 mmol/L mean cholesterol lowering).63
Intervention nurses worked exclusively on providing
screening, counseling, and follow-up, and each nurse
was fully occupied providing care to an average of
about 300 patients during the year.
In summary, the British Family Heart Study authors
reported that nurse-led programs of cardiovascular
screening and lifestyle intervention in general practice
produced slightly lower weight, blood pressure, and
blood cholesterol concentration in the intervention
group at 1 year. If these reductions could be sustained,
they would correspond to a 12% lower risk of coronary
heart disease events. Based on these results, the authors
concluded that this level of intervention in primary
care was not justified and suggested that primary care
practitioners alone cannot provide a population-based
primary prevention approach to reduce cardiovascular
disease risk. On the other hand, one might argue that
a 12% reduction of risk at a population level is quite
substantial and may even be cost-effective. Subsequent
cost-effectiveness analyses conducted for both the
OXCHECK and Family Heart Study concluded that the
OXCHECK program would become cost effective if the
effect lasted ⱖ5 years (an additional 2 years after the
end of the study), while, for the British Family Heart
study, the effect must last for about 10 years to justify
the cost associated with the intervention delivered in
that trial.106,107
A primary care– based secondary prevention study,
included in both the Ketola et al.47 and McAlister et
al.48 reviews, targeted 688 patients with angina within
18 general group practices in Ireland.53 Patients were
randomized to either a health education intervention
Am J Prev Med 2004;27(2S)
69
condition or assessment only. The initial health education intervention was delivered by research staff either
at the practice or at the subject’s home, and follow-up
education was provided every 4 months for 2 years. At
the end of 2 years, based on self-report, the intervention group was significantly more physically active,
more likely to report healthy eating and was less likely
to report restriction of activity by angina. However,
were no significant differences in smoking, blood pressure, cholesterol concentration, or body mass index.53
Another primary care– based secondary prevention
trial95,96 was reported in the McAlister et al.48 review.
Over 1100 patients with known or suspected coronary
heart disease were recruited from 19 general practices
in Scotland. Nurses recruited from each of the study
practices were trained by study staff to deliver the
disease management intervention, which included
health behavior counseling and review of cardiac medications. Patients randomized to receive the intervention attended an initial visit of approximately 45 minutes and were encouraged to attend follow-up visits
every 2 to 6 months. The average intervention time over
the 1-year intervention period was 1 hour and 22
minutes per patient.95,96 Significant improvements in
diet and physical activity were found for patients in the
intervention condition compared to the control group,
along with improvements in medication use and blood
pressure and lipid management.95,96 The initial report
from this trial did not describe changes in cardiovascular events or mortality, which led to its exclusion from
the Ketola et al.47 review.
In a recently published 4.7-year follow-up report of
the Scottish primary care trial,108 investigators reported
that all improvements noted at the end of the 1-year
intervention, except improvements in exercise, were
sustained over 4.7 years.108 The usual care control
group also improved over the follow-up period, so
differences in risk behaviors between intervention and
control conditions were no longer significant at the
final follow-up.108 However, the authors suggest that
this loss of effect on risk behaviors over time was largely
due to control subjects’ participation in secondary
prevention programs that were available to all subjects
during the follow-up period.108 Despite this crossover
effect, a significant impact of the intervention on
mortality and cardiac events was noted after 4.7 years,
suggesting that the benefits produced during the 1-year
intervention period impacted progression of cardiac
illness over the subsequent 3 to 4 years.108
Interventions to Address Multiple Behavioral
Risk Factors in Diabetes Care
Diabetes care trials provide another source of evidence
for interventions targeting multiple health behaviors.
These are considered to be secondary prevention trials
because they target a subgroup of patients with pre70
existing disease. In addition to targeting behaviors that
are specific to diabetes (e.g., blood glucose monitoring,
foot exams), diabetes care intervention trials usually
also address diet and exercise and sometimes smoking
cessation. We have identified three systematic reviews
in diabetes care that have summarized the effectiveness
of interventions targeting health behaviors and also
meet our inclusion criteria.49 –51 These reviews address
a range of interventions, from those that emphasize
providing patient education and self-management support, to more intensive interventions that involve case
or care managers and include systems-level interventions that address the organization and delivery of
care.109 We will describe the conclusions of these three
reviews emphasizing, whenever possible, the interventions elements that are associated with improved
outcomes.
A 2001 report by the Alberta Heritage Foundation
for Medical Research provided a review of reviews of
diabetes education intervention trials.49 Included in
this review were 17 reports, including three metaanalyses, seven systematic reviews, and seven additional
trials with ⱖ1 year of follow-up and more than one
patient contact. The authors concluded that although
patient education is associated with short-term diabetes
control, long-term outcomes have yet to be established.49 This report also concluded that providing
patients with knowledge about diabetes is necessary,
but insufficient to improve diabetes care. Goal setting,
assessment of patient-specific barriers, and a focus on
behavioral strategies and problem solving to address
barriers appear to be important to produce an impact
on diabetes outcomes.49
Norris et al.50 identified 72 RCTs in their systematic
review of self-management training in people with
type-2 diabetes. These authors defined self-management training as “the process of teaching individuals to
manage their disease.”50 As the authors point out, the
educational techniques used in these studies have
shifted from didactic presentations and clinician-centered interventions to those involving patient activation
and empowerment.110 Still, the interventions included
in this review were extremely varied and included both
didactic and collaborative approaches targeting a broad
array of outcomes, including knowledge, skill development, lifestyle behaviors, physiological outcomes, and
quality of life.50 Only 9 of the 72 studies focused on
multiple behavioral outcomes (usually diet and exercise behaviors) and results of these were variable.50
Norris et al.50 conclude that evidence supports shortterm effectiveness of self-management training, but
there is insufficient evidence for sustained effects on
glycemic control, cardiovascular risk factors, cardiovascular disease, and quality of life.50 However, the authors
found that interventions with regular reinforcement
were more effective than single sessions or only limited
follow-up.50 Interventions that emphasized patient par-
American Journal of Preventive Medicine, Volume 27, Number 2S
ticipation or collaboration produced more favorable
results on glycemic control, weight loss, and lipid
profiles than didactic clinician-centered interventions.50 Group education appeared to be more effective
for lifestyle interventions.50
A systematic review of diabetes disease management,
conducted by the Task Force on Community Preventive
Services, reviewed 27 studies of disease management
and 15 studies of case management.51 Although there
was evidence for the effectiveness of disease management and case management on glucose control, the
authors also concluded there was insufficient evidence
for disease management or case management to determine the effectiveness on weight, BMI, blood pressure,
and lipid concentration.51 They also noted that there is
limited information about the relative value of specific
components of disease management interventions, although providing patients with education, reminders,
and support appear to be important.51
Three recently reported trials, not included in the
above reviews, provide new evidence regarding the
impact of interventions targeting multiple behavioral
risk factors in patients with diabetes as well as patients
at risk for developing diabetes. The Diabetes Prevention Program (DPP) was a large multicentered RCT
involving 3234 adults who were at risk for the development of type-2 diabetes.111 The DPP was designed to
test whether a lifestyle intervention or metformin, a
antihyperglycemic agent, would prevent or delay the
onset of diabetes.111 The lifestyle intervention consisted
of an individualized 16-lesson curriculum addressing
diet, weight loss, physical activity, and behavior modification delivered by case managers on a one-to-one basis
during a 6-month period.111 Follow-up individual sessions were held on a flexible schedule, usually monthly.111 Subjects, who all had evidence for impaired
glucose tolerance that put them at greater risk for
developing type-2 diabetes, were randomized to one of
three conditions: standard lifestyle recommendations
plus metformin, standard lifestyle recommendations
plus placebo, or the intensive lifestyle intervention.
After an average follow-up of 2.8 years, the lifestyle
intervention reduced the incidence of diabetes by 58%
compared with placebo (95% CI⫽48%– 66%).111 Although metformin also significantly reduced the incidence of diabetes (by 31%, 95% CI⫽17%– 43%), the
lifestyle intervention was significantly more effective
than metformin111 The lifestyle intervention also produced significantly greater changes in diet, significantly
greater weight loss, and significantly greater increases
in physical activity than metformin or placebo.111 The
authors calculated that the effect of the multiple-riskbehavior lifestyle intervention translates to one case of
diabetes prevented per seven persons treated for 3
years.111
Another recent RCT tested the effects of an intensive
multifactorial intervention (that included behavioral
risk factor intervention) on cardiovascular mortality in
160 adult patients with type-2 diabetes.112 The intensive
intervention, delivered by a multidisciplinary team
(physician, nurse, dietitian) in a Danish Diabetes Center, employed behavioral modification strategies to
target diet, exercise, and smoking cessation in individual consultations every 3 months.112 The intensive
intervention also included stepwise implementation of
pharmacologic therapy targeting hyperglycemia, hypertension, dyslipidemia, and microalbuminuria, as well as
aspirin therapy. The control condition received primary care– based treatment informed by conventional
guidelines. After a mean follow-up of 7.8 years, subjects
in the multifactorial intervention had an approximately
50% reduction in cardiovascular and microvascular
events compared to conventional treatment.112 However, effects of the multifactorial intervention on behavioral risk factors were modest and only reduction in fat
intake was significantly different between groups.112
Although the design of the study did not allow the
investigators to identify which combination of interventions was responsible for the positive findings, the
results of this study underscore several of the findings
of the systematic reviews described above,49 –51 including the value of a multidisciplinary team, combining
medication with self-management education, targeting
behavioral risk factors, and emphasizing goal setting
and regular follow-up.
In the Finnish Diabetes Prevention Study, investigators randomly assigned 522 middle-aged overweight
subjects (172 men and 350 women) with impaired
glucose tolerance to seven individualized counseling
sessions over 1 year with quarterly follow-up, or to a
usual-care control condition with a diet/exercise pamphlet and general advice at baseline and annual followup.113 The counseling sessions were provided by nutritionists and focused on helping participants achieve a
whole-grain, whole-foods, low-fat, and monounsaturated-fat diet, with intervention goals of reduced weight by
⬎5%, reduction in total fat to ⬍30% total energy,
reduction in saturated fat to ⬍10% energy, increased
fiber, and moderate-intensity exercise of ⬎30 minutes
daily. After 1 year, the intervention group achieved a
net weight loss of 3.4 kg (p ⬍0.001) and the cumulative
incidence of diabetes after 4 years was 11% (95%
CI⫽6% to 15%) in the intervention group compared to
23% (95% CI⫽17% to 29%) in the control group.113
The risk of diabetes was directly associated with change
in lifestyle, such that the more goals achieved by
participants at 1 year, the lower the incidence of
diabetes.113 Recent reports from the Finnish Diabetes
Prevention Study investigators indicate that the intensive lifestyle intervention produced not only long-term
(i.e., 3 years) beneficial changes in diet, physical activity, and weight, but also improvement in clinical and
biochemical parameters of diabetes risk (e.g., glycemia,
lipemia, and insulin sensitivity).114,115 Additional studAm J Prev Med 2004;27(2S)
71
ies by this research group from the National Public
Health Institute of Finland are currently ongoing to
determine how the techniques used in this clinical trial
can be successfully implemented in primary care.
Summary of the Evidence
To address the health needs of the nation, there is
clearly a mandate to focus on four key behavioral risk
behaviors: lack of regular physical activity; unhealthy
diet/obesity; smoking; and risky/harmful alcohol use.
Our review of the evidence indicates that there are
evidence-based single behavioral risk factor interventions that primary care clinicians can employ to reduce
smoking18,21 and risky/harmful alcohol use19,20,44,45 in
unselected patients. These efficacious interventions include brief advice and counseling,18 –21,44,45 interventions that are feasible in primary care settings. To
address unhealthy diets, there is evidence for the
efficacy of medium- to high-intensity dietary counseling
delivered by specially trained clinicians to high-risk
patients.14,15 There is also fair to good evidence that
high-intensity counseling and behavioral intervention
strategies that address physical activity, dietary improvement, or both, produce moderate, sustained weight loss
in obese patients.16,17 Based on this evidence, the
USPSTF has recently recommended: (1) screening for
tobacco use,18 alcohol misuse,19 and obesity17; (2) brief
primary care– based counseling for tobacco18 and alcohol misuse19; (3) intensive behavioral dietary counseling for adult patients at high risk15; and (4) intensive
counseling and behavioral interventions for obese patients.17 Although the evidence for the efficacy of
physical activity interventions in primary care is limited,12,13 evidence-based recommendations for community activities and supports for regular physical activity
help fill current evidence gaps.25,27 See Table 1 for a
summary of the evidence linking single behavioral risk
factor counseling to health behavior change.
However, large gaps remain in our knowledge about
the efficacy of interventions to address multiple behavioral risk factors in primary care. The most promising
evidence for addressing multiple behavioral risk factors
comes from interventions that address secondary prevention among patients with existing cardiovascular
disease and diabetes or patients who are at risk for these
illnesses. Once illness is present, there is a growing
body of evidence to support the impact of multitargeted multimodal risk factor interventions on a variety
of outcomes, including change in health risk behaviors.46 –51,93,108,111–113,116 Some of the most promising
multiple behavioral risk factor interventions have been
developed under the rubric of disease management,
care management or self-management support.48 –51
Since most adults aged ⬎50 have one or more chronic
conditions, a growing proportion of the population
72
would benefit from multiple risk factor interventions
that target patients with existing disease.
Most of the studies that demonstrate the benefit of
multiple behavioral risk factor interventions have been
conducted in research clinics or specialty settings.
Though the intensive interventions delivered in many
of these studies would not be feasible in primary care
settings, one might argue that they could be directly
linked to primary care settings if they were available on
a referral basis. Relatively little available evidence addresses the efficacy of multiple risk behavior interventions that are delivered within primary care settings,
particularly for primary prevention, that is, for patients
without an existing illness such as diabetes and cardiovascular disease.46 –51
However, the few studies that have tested multiple
risk behavior interventions in primary care have generally found significant but small effects on health behavior endpoints.53,63,76,95,96,105,108 One example is the
10% to 12% reduction in risk scores reported by
researchers directing the British Heart Health Study.63
Although some have questioned the value of this modest reduction in risk, others have argued strongly that,
from a population standpoint, this level of risk reduction, if sustained over time, would translate into highly
significant and important changes in cardiovascular
disease incidence as well as subsequent morbidity and
mortality.117 The potential for realizing such benefits in
patients with existing illness was recently bolstered by
the publication of the long-term morbidity and mortality outcomes of the Scottish primary care– based secondary prevention trial.108 Although delivered in more
intensive specialty clinic settings, the impressive reduction in cardiovascular disease events achieved by the
Danish multifactorial intervention in patients with
type-2 diabetes,112 and the marked reduction in the
incidence of diabetes achieved by the DPP’s and the
Finnish Prevention Study’s diet, exercise, and behavioral modification interventions,111,113 provide powerful examples of the potential of multiple behavioral risk
factor interventions to prevent the incidence of disease.
Limitations of the Existing Evidence
A limitation of much of the research we have reviewed
for this paper is reliance on results obtained among the
subset of patients who are willing to participate in
controlled clinical trials. This is especially true when
testing interventions that require enrolled patients to
undergo repeated demanding assessments and participate in intensive interventions over long periods of
time. It is particularly problematic to compare effect
sizes across studies that vary in the demands placed on
subjects (e.g., brief counseling in primary care versus
multiple and frequent intensive counseling sessions in a
specialty setting), as these studies are likely to enroll
samples with different levels of motivation as well other
American Journal of Preventive Medicine, Volume 27, Number 2S
variables that may influence responsiveness to an intervention.118,119 These limitations apply to the systematic
reviews of dietary counseling interventions and obesity
interventions conducted by the USPSTF.14,16 Moreover,
intensive face-to-face intervention modalities will have
limited impact if they cannot be delivered consistently
to large segments of the target population.118,119
On the other side of the coin, as noted previously,
the smaller effects obtained by primary care– based
interventions may actually produce greater impacts on
the population level if they are able to reach a much
larger proportion of the population of patients that
would benefit from the service.117 One strategy for
overcoming obstacles to increasing the reach of an
intensive intervention is to consider how to facilitate
“hand-offs” or referrals between primary care clinicians
and specialty services or programs that can provide
more intensive interventions. Harnessing interactive
technology to help integrate more intensive interventions within primary care or community settings is
another strategy for increasing the reach and impact of
these interventions. See the article on interactive technology by Glasgow et al.120 in this supplement for
further discussion of this promising approach. The
article on translating what we have learned into practice by Glasgow et al.121 in this supplement highlights
the challenges as well as the opportunities for translating research findings into real-world primary care
settings.
Another important limitation of the body of research
that we have reviewed is the lack of attention paid to the
responsiveness of important subgroups of patients
(e.g., patients from minority groups; older adults; patients with low literacy levels) to the interventions of
interest. The lack of uniform inclusion criteria across
the systematic reviews cited in this paper (e.g., some
included only RCTs while others included other less
tightly controlled designs; inclusion criteria regarding
acceptable follow-up periods varied) is yet another
significant limitation to our findings. This limitation is
especially important when comparing the recommendations and findings that have emerged from the
USPSTF and the Community Task Force. Also, several
of the systematic reviews identified other methodologic
issues that limited the quality of the body of research
that was reviewed. These include lack of standard
outcome measures (particularly for diet and exercise
outcomes), failure to report intervention implementation rates (important to internal validity), and inability
to determine the effects of individual elements of
complex interventions. Moreover, we did not review
behavioral risk factor interventions in pediatric and
adolescent populations and we did not review the
impact of interventions that are delivered primarily in
community settings, such as peer-led interventions
or those delivered in work sites and faith-based
organizations.
Intervention Elements Associated with Improved
Health Behavior Outcomes
What can we learn from existing intervention research
about the intervention elements that are associated
with improved health behavior outcomes? Although
few studies have been designed to systematically address this question, the following intervention elements
have been associated with positive outcomes in single
behavioral risk factor intervention research:
●
●
●
●
●
●
●
Assessment of patient characteristics and needs and
subsequent tailoring of intervention elements to address assessment14,16,20,25,29,45
Behavioral interventions (especially those that include self-monitoring, collaborative goal setting and
active problem solving)14,16,20,21,27,45
Combined behavioral and pharmacologic interventions16,20,21
Supportive elements (both within and outside of
intervention)16,20,21,25,27,29
Use of multiple modalities14,16,20,21
Multiple contacts16,20,21,45
Inclusion of organizational or system elements to
prompt patients and clinicians.14,20,21,29,36
Within multiple behavioral risk factor intervention
trials, the relative importance and mix of specific
intervention elements is less clear. The added complexity of addressing multiple behaviors may make it impossible, and even undesirable, to disentangle all intervention elements in controlled research trials. However,
existing evidence from disease management and selfmanagement research suggests that the following elements promote positive outcomes:
●
●
●
●
●
Assessment and tailoring of the intervention to patient needs48 –51,122,123
Greater effectiveness of interactive education and skill
building compared to didactic education49 –51,122,123
Self-monitoring, goal setting, identification of barriers, and problem solving49 –51,122,123
Use of multidisciplinary teams or nurse-led
programs48 –51,122,123
Multiple follow-up contacts46 –51,122,123
Recommendations
Recommendations: Principles to Guide
Intervention
As noted in the epidemiologic papers in this supplement by Fine et al.5 and Coups et al.,6 a majority of
individuals are at risk from more than one of the four
behavioral risk factors that are the focus of this review.
It is not reasonable to expect clinicians in primary care
settings to deliver unique interventions for each of
these four behavioral risk factor independently of the
others, or independent of the long list of other preventive services that primary care clinicians are urged to
Am J Prev Med 2004;27(2S)
73
address. On the hand, the conceptual frameworks and
intervention elements that are associated with health
risk behavior change are not different for different
behaviors.7,9,124,125 That is good news for clinicians and
health systems who do not have to use a different
intervention approach for each specific behavior. The
USPSTF Counseling and Behavioral Interventions
Work Group recently recommended adoption of the
“5As” construct as a unifying conceptual framework for
evaluating and describing health behavioral counseling
interventions in primary and general healthcare settings.9 The 5A’s framework (assess, advise, agree, assist,
arrange follow-up) is derived from the “4A’s” approach
to smoking-cessation counseling developed by the National Cancer Institute in the late 1980s.126 This approach has also been applied to nontobacco health
behaviors 9,125,127–129 and the self-management component of chronic illness care.123,124 See Appendix A for a
summary of the 5A’s construct, adapted from the
USPSTF Counseling and Behavioral Interventions
Work Group report.9
We strongly recommend use of the 5A’s approach as
a strategy for implementing evidence-based behavioral
risk factor interventions across multiple counseling
targets. Evidence supporting each of the elements of
the 5A’s is noted below:
Assess refers to assessment of patient behaviors, and
may also include assessment of patients’ knowledge,
beliefs, attitudes, and preferences. This step is necessary to identify those in need of behavioral interventions and, when appropriate, to permit tailoring of a
health behavior change intervention.14,16,20,25,29,45,49 –
43
51,122 See the assessment paper by Babor et al.
in
this supplement for a review of strategies and tools
for assessing the four key risk behaviors. Assessment
can be addressed in a number of ways to avoid
overburdening the primary care clinician, including
use of pre-visit health risk appraisal instruments,
questionnaires, or interactive computer-based systems.130 See also the interactive technology article by
Glasgow et al.120 in this supplement. Depending on
the behavior addressed, assessment may also include
identification of physiologic risk factors (e.g., hypertension, abnormal lipids, body mass index) and
family history to guide decisions about the intensity
of intervention and the use of pharmacologic interventions to address risk.
Advise is supported by the evidence for the impact of
brief clinician advice, especially when addressing
tobacco use21,33 and risky alcohol use.19,20,44 However, for risky alcohol use, very brief or brief single
contact interventions have limited efficacy.20 Advice
is most effective when it is personalized and relates to
a patient’s symptoms, values, and concerns.124,125,131
Agree is the important step of collaboratively identifying behavioral and self-management goals. As noted,
74
active participation of patients in the goal-setting
process is associated with improved outcomes, particularly in studies of dietary14 and alcohol counseling42
and diabetes self-management education.29,49 –51,124
Assist includes providing behavioral counseling to help
patients to develop a specific tailored action plan that
includes helping them to identify, address and overcome barriers and develop the behavioral skills and
confidence they need to successfully change and maintain health behaviors.14,16,21,29,42,45,49 –51,122,124,132 The
primary care clinician might hand-off this step to a
nurse or other specially trained clinician, especially when addressing dietary change or obesity or
when more intensive intervention is needed or
desired.14,16,21,42,48 –51,95,122,124
Arrange includes making specific plans for subsequent
contacts with the primary care team, as well as with
clinicians with special expertise in addressing health
risk behaviors and self-management.14,16,21,29,42,48 –51
Follow-up might be provided through means other
than face-to-face intervention, such as via telephone
or interactive technology.120 –122,133
One of the key advantages of providing behavioral
risk factor intervention in the primary care setting is the
opportunity to take advantage of strong clinician–
patient relationships, which have been linked with
increased patient participation in health behavior
change, as well as other aspects of care.125,134 –136 The
adoption of patient-centered, empowering, and collaborative approaches to behavior change counseling and
self-management increase the influence and effectiveness of primary care clinicians’ counseling interventions.8,123,131,135,137–140 Another advantage of primary
care is the longitudinal nature of primary care practice,
which permits clinicians to deliver elements of the 5A’s
through multiple contacts over time, while also taking
advantage of teachable moments when new symptoms
or patient concerns might be linked to problematic
health behaviors or risks.141,142
To take full advantage of interventions such as 5A’s
counseling, we must recognize that they are delivered
in a series of contexts, including (1) the systems that
support the healthcare team (e.g., teamwork, provider
training, reminders); (2) the healthcare delivery system
(e.g., availability of referrals for more intensive dietary
and obesity counseling); and (3) community resources
(e.g., access to safe and convenient sites for physical
activity, reminders to use them). The paper in this
supplement on translating what we have learned into
practice by Glasgow et al.121 describes and details the
principles, practices, and systems that can be applied at
the practice or health system level to promote successful adoption, implementation, and maintenance of
multiple behavioral risk factor interventions in primary
care settings. A brief list of contextual factors that
American Journal of Preventive Medicine, Volume 27, Number 2S
influence successful implementation, based in part on
evidence reviewed in the present paper, follows:
●
●
●
●
●
System supports (e.g., computerized assessment; reminders, decision-support tools, feedback) clearly
enhance the success of health behavior counseling
interventions and are especially integral to the
delivery of multiple risk behavior interventions.14,20,21,109,122,124,133,143
Use of multidisciplinary or nurse-led teams to share
the responsibility and burden of delivering interventions, especially in the setting of chronic illness care
or when more intensive levels of behavioral counseling are needed or desired.14,20,21,48 –51,122,124,133,143
Clinician and staff training is needed to optimize the
delivery of effective patient-centered counseling.20,21,123,137,144,145
Referral to or use of more intensive interventions
may be needed when patients are alcohol dependent,
fail initial treatment for tobacco dependence, or
require intensive dietary or obesity counseling.14,16,20,44 Stepped care models such as the one
proposed for tobacco dependence may prove valuable in addressing this need.35
Use of community-based community approaches enhances smoking cessation and physical activity adoption, and may also improve other health behavior
outcomes.25,26,146
Recommendations: Future Research
The body of research conducted on multiple behavioral risk factor interventions is quite sparse, especially
when considering studies performed within primary
care settings. Much of the primary care research we
cited was conducted in Western Europe and may not
directly apply to U.S. healthcare systems and populations. Thus, there is a clear need to conduct controlled
multiple risk factor intervention trials in primary care
settings, especially in the United States. These trials
should test interventions that can realistically be
adopted, implemented, and maintained in primary
care settings. Because of the wide variety of types of
primary care settings in the United States (e.g., publicly
supported community health centers, health maintenance organization, hospital-based clinics, private office practices), both generic interventions that would
apply across type and specific interventions tailored to
the type of setting need to be developed and tested.
Many more narrowly defined questions remain about
the efficacy and effectiveness of multiple behavioral risk
factor interventions in primary care. These include
questions about the relative importance of sequencing
multiple behavioral risk factor interventions versus a
simultaneous approach; strategies for balancing clinician and patient preferences; use of the physician (or
nurse practitioner or physician assistant) to motivate
and support versus personally deliver counseling inter-
ventions; use of multidisciplinary teams to share responsibility for intervention; use of telecommunications and/or interactive technology to support and
extend primary care– based intervention; use of strategies to facilitate hand-offs or referral to more intensive
programs; use of group formats and settings for delivering interventions; and assessing the needs and response of specific subpopulations.
Preparation of this article was supported by a grant from The
Robert Wood Johnson Foundation. We gratefully acknowledge the input and feedback provided by all members of the
Planning Committee of the Addressing Multiple Behavioral
Risk Factors in Primary Care Project.
References
1. U.S. Department of Health and Human Services. Healthy people 2010.
Washington DC: U.S. Government Printing Office, 2000.
2. Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death
in the United States, 2000. JAMA 2004;291:1238 –45.
3. National Center for Health Statistics. Health, United States, 2003. Hyattsville MD: National Center for Health Statistics, 2003.
4. Davis D, Schoenbaum SC, Collins KS, Teeney K, Hughes DL, Audet A-MJ.
Room for improvement: patients report on the quality of their health
care. New York: The Commonwealth Fund, 2002.
5. Fine LJ, Philogene GS, Gramling R, Coups EJ, Sinha S. Prevalence of
multiple chronic disease risk factors: 2001 National Health Interview
Survey. Am J Prev Med 2004;27(suppl 1):18 –24.
6. Coups EJ, Gaba A, Orleans CT. Physician screening for multiple behavioral health risk factors. Am J Prev Med 2004;27(suppl 1):34 – 41.
7. Glasgow RE, Orleans CT, Wagner EH. Does the chronic care model serve
also as a template for improving prevention? Milbank Q 2001;79:579 –612.
8. Ockene JK, Zapka JG. Provider education to promote implementation of
clinical practice guidelines. Chest 2000;118:33S–39S.
9. Whitlock EP, Orleans CT, Pender N, Allan J. Evaluating primary care
behavioral counseling interventions: an evidence-based approach. Am J
Prev Med 2002;22:267–84.
10. Ockene JK, McBride PE, Sallis JF, Bonollo DP, Ockene IS. Synthesis of
lessons learned from cardiopulmonary preventive interventions in healthcare practice settings. Ann Epidemiol 1997;S7:S32–45.
11. Harris RP, Helfand M, Woolf SH, et al. Current methods of the U.S.
Preventive Services Task Force: a review of the process. Am J Prev Med
2001;20:21–35.
12. Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does
counseling by clinicians improve physical activity? A summary of the
evidence for the U.S. Preventive Services Task Force. Ann Intern Med
2002;137:208 –15.
13. U.S. Preventive Services Task Force. Behavioral counseling in primary
care to promote physical activity: recommendation and rationale. Ann
Intern Med 2002;137:205–7.
14. Pignone MP, Ammerman A, Fernandez L, et al. Counseling to promote a
healthy diet in adults: A summary of the evidence for the U.S. Preventive
Services Task Force. Am J Prev Med 2003;24:75–92.
15. U.S. Preventive Services Task Force. Behavioral counseling in primary
care to promote a healthy diet: recommendations and rationale. Am J
Prev Med 2003;24:93–100.
16. McTigue KM, Harris R, Hemphill B, et al. Screening and interventions for
obesity in adults: summary of the evidence for the U.S. Preventive Services
Task Force. Ann Intern Med 2003;139:933–49.
17. U.S. Preventive Services Task Force. Screening for obesity in adults:
recommendations and rationale. Ann Intern Med 2003;139:930 –2.
18. U.S. Preventive Services Task Force. Counseling to prevent tobacco use
and tobacco-caused disease: recommendation statement. Rockville MD:
Agency for Healthcare Research and Quality, 2003.
19. U.S. Preventive Services Task Force. Screening and behavioral counseling
interventions in primary care to reduce alcohol misuse: recommendation
statement. Ann Intern Med 2004;140:554 –6.
20. Whitlock EP, Polen MR, Green CA, Orleans T, Klein J. Behavioral
counseling interventions in primary care to reduce risky/harmful alcohol
Am J Prev Med 2004;27(2S)
75
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
76
use by adults: a summary of the evidence for the U.S. Preventive Services
Task Force. Ann Intern Med 2004;140:557–68.
Fiore M, Bailey W, Cohen S, et al. Treating tobacco use and dependence,
clinical practice guideline. Rockville MD: U.S. Department of Health and
Human Services, Public Health Service, 2000.
Truman BI, Smith-Akin CK, Hinman AR, et al. Developing the Guide to
Community Preventive Services— overview and rationale. The Task Force
on Community Preventive Services. Am J Prev Med 2000;18:18 –26.
Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for
patients with chronic illness. JAMA 2002;288:1775–9.
Glasgow RE, Strycker LA, Toobert DJ, Eakin E. A social-ecologic approach
to assessing support for disease self-management: the Chronic Illness
Resources Survey. J Behav Med 2000;23:559 –83.
Task Force on Community Preventive Services. Increasing physical activity. A report on recommendations of the Task Force on Community
Preventive Services. MMWR Recomm Rep 2001;50:1–14.
Task Force on Community Preventive Services. Recommendations regarding interventions to reduce tobacco use and exposure to environmental
tobacco smoke. Am J Prev Med 2001;20:10 –5.
Kahn EB, Ramsey LT, Brownson RC, et al. The effectiveness of interventions to increase physical activity. A systematic review. Am J Prev Med
2002;22:73–107.
Glasgow RE, Bull SS, Gillette C, Klesges LM, Dzewaltowski DA. Behavior
change intervention research in healthcare settings. a review of recent
reports with emphasis on external validity. Am J Prev Med 2002;23:62–9.
Ammerman A, Pignone M, Fernandez L. Counseling to promote a healthy
diet. Rockville MD: Agency for Health Care Research and Quality, 2003
(systematic evidence review 18).
NHLBI Obesity Education Initiative. Clinical guidelines on the identification, evaluation and treatment of overweight in adults: the evidence
report. Bethesda MD: National Institutes of Health, National Heart, Lung
and Blood Institute, 1998.
NHS Centre for Reviews and Dissemination. The prevention and treatment of obesity. Eff Health Care 1997;3:1–12.
Douketis JD, Feightner JW, Attia J, Feldman WF. Periodic health examination, 1999 update: 1. Detection, prevention and treatment of obesity.
Canadian Task Force on Preventive Health Care. CMAJ 1999;160:513–25.
U.S. Preventive Services Task Force. Guide to clinical preventive services.
2nd ed. Baltimore: Williams &Wilkins, 1996.
Lichtenstein E, Hollis J. Patient referral to a smoking cessation program:
who follows through? J Fam Pract 1992;34:739 –44.
Abrams DB, Orleans CT, Niaura RS, Goldstein MG, Prochaska JO, Velicer
W. Integrating individual and public health perspectives for treatment of
tobacco dependence under managed health care: a combined steppedcare and matching model. Ann Behav Med 1996;18:290 –304.
Strategies for reducing exposure to environmental tobacco smoke: increasing tobacco-use cessation and reducing initiation in communities
and health-care systems. MMWR Recomm Rep 2000;49:1–11.
Fiellin DA, Reid MC, O’Connor PG. Screening for alcohol problems in
primary care: a systematic review. Arch Intern Med 2000;160:1977–89.
Reinert DF, Allen JP. The Alcohol Use Disorders Identification Test
(AUDIT): a review of recent research. Alcohol Clin Exp Res 2002;26:272–
9.
Allen JP, Reinert DF, Volk RJ. The alcohol use disorders identification
test: an aid to recognition of alcohol problems in primary care patients.
Prev Med 2001;33:428 –33.
Fleming MF, Graham AW. Screening and brief interventions for alcohol
use disorders in managed care settings. Recent Dev Alcohol 2001;15:393–
416.
Bradley KA, Boyd-Wickizer J, Powell SH, Burman ML. Alcohol screening
questionnaires in women: a critical review. JAMA 1998;280:166 –71.
Whitlock EP, Green CA, Polen MR. Behavioral counseling interventions
in primary care to reduce risky/harmful alcohol use. Rockville MD:
Agency for Healthcare Research and Quality, 2004 (systematic evidence
review 30).
Babor TF, Sciamanna CN, Pronk N. Addressing multiple risk behaviors in
primary care: screening issues and related concepts. Am J Prev Med
2004;27(suppl 1):42–53.
Moyer A, Finney JW, Swearingen CE, Vergun P. Brief interventions for
alcohol problems: a meta-analytic review of controlled investigations in
treatment-seeking and non-treatment-seeking populations. Addiction 2002;
97:279 –92.
Babor TF, Higgins-Biddle JC. Brief intervention for hazardous and
harmful drinking: a manual for primary care. Geneva: World Health
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
Organization, Department of Mental Health and Substance Dependence,
2001.
Ebrahim S, Davey Smith G. Multiple risk factor interventions for primary
prevention of coronary heart disease (Cochrane Review), vol. 2003: The
Cochrane Library, issue 2, 2003:CD001561.
Ketola E, Sipila R, Makela M. Effectiveness of individual lifestyle interventions in reducing cardiovascular disease and risk factors. Ann Med
2000;32:239 –51.
McAlister F, Lawson F, Teo K, Armstrong P. Randomized trials of
secondary prevention programmes in coronary heart disease: systematic
review. BMJ 2001;323:957–62.
Corabian P, Harstall C. Patient diabetes education in the management of
adult type-2 diabetes. Edmonton, Alberta, Canada: Alberta Heritage
Foundation for Medical Research, 2001.
Norris SL, Engelgau MM, Narayan KMV. Effectiveness of self-management
training in type-2 diabetes: a systematic review of randomized controlled
trials. Diabetes Care 2001;24:561–87.
Norris SL, Nichols PJ, Caspersen CJ, et al. The effectiveness of disease and
case management for people with diabetes. A systematic review. Am J Prev
Med 2002;22:15–38.
Agewall S, Wikstrand J, Samuelsson O, Persson B, Andersson OK, Fagerberg B. The efficacy of multiple risk factor intervention in treated
hypertensive men during long-term follow up. Risk Factor Intervention
Study Group. J Intern Med 1994;236:651–9.
Cupples ME, McKnight A. Randomised controlled trial of health promotion in general practice for patients at high cardiovascular risk. BMJ
1994;309:993–6.
Jula A, Rönnemaa T, Rastas M, Karvetti R-L, Mäki J. Long-term nonpharmacological treatment for mild to moderate hypertension. J Intern
Med 1990;227:413–21.
Niebauer J, Hambrecht R, Velich T, et al. Predictive value of lipid profile
of salutary coronary angiographic changes in patients on a low-fat diet and
physical activity program. Am J Cardiol 1996;78:163–7.
Peréz-Stable EJ, Coates EJ, Baron RB, et al. Comparison of a lifestyle
modification program with propanolol use in the management of diastolic hypertension. J Gen Intern Med 1995;10:419 –28.
Haskell WL, Alderman DL, Fair JM, et al. Effects of intensive multiple risk
factor reduction on coronary atherosclerosis and clinical cardiac events in
men and women with coronary artery disease: the Stanford Coronary Risk
Intervention Project SCRIP. Circulation 1994;89:975–90.
Stamler R, Stamler J, Gosch FC, et al. Primary prevention of hypertension
by nutritional-hygienic means. Final report of a randomized, controlled
trial. JAMA 1989;262:1801–7.
Stamler R, Stamler J, Grimm R, et al. Nutritional therapy for high blood
pressure. Final report of a four-year randomized controlled trial—the
Hypertension Control Program. JAMA 1987;257:1484 –91.
Hamalainen H, Luurila OJ, Kallio V, Knuts LR, Arstila M, Hakkila J.
Long-term reduction in sudden deaths after a multifactorial intervention
programme in patients with myocardial infarction: 10-year results of a
controlled investigation. Eur Heart J 1989;10:55–62.
Kallio V, Hamalainen H, Hakkila J, Luurila OJ. Reduction in sudden
deaths by a multifactorial intervention programme after acute myocardial
infarction. Lancet 1979;2:1091–4.
Vermeulen A, Lie KI, Durrer D. Effects of cardiac rehabilitation after
myocardial infarction: changes in coronary risk factors and long-term
prognosis. Am Heart J 1983;105:798 –801.
Randomised controlled trial evaluating cardiovascular screening and
intervention in general practice: principal results of British family heart
study. Family Heart Study Group. BMJ 1994;308:313–20.
Miettinen TA, Huttunen JK, Naukkarinen V, et al. Multifactorial primary
prevention of cardiovascular diseases in middle-aged men. Risk factor
changes, incidence, and mortality. JAMA 1985;254:2097–102.
Naukkarinen VA, Strandberg TE, Vanhanen HT, Salomaa VV, Sarna SJ,
Miettinen TA. Mortality rates after multifactorial primary prevention of
cardiovascular diseases. Ann Med 1989;21:441–6.
Strandberg TE, Salomaa VV, Naukkarinen VA, Vanhanen HT, Sarna SJ,
Miettinen TA. Long-term mortality after 5-year multifactorial primary
prevention of cardiovascular diseases in middle-aged men. JAMA 1991;
266:1225–9.
Strandberg TE, Salomaa UV, Naukkarinen VA, Vanhanen HT, Sarna SA,
Miettinen TA. Cardiovascular morbidity and multifactorial primary prevention: fifteen-year follow-up of the Helsinki Businessmen Study. Nutr
Metab Cardiovasc Dis 1995;5:7–15.
American Journal of Preventive Medicine, Volume 27, Number 2S
68. Knutsen SF, Knutsen R. The Tromso Heart Study: family approach to
intervention on CHD. Feasibility of risk factor reduction in high-risk
persons—project description. Scand J Soc Med 1989;17:109 –19.
69. Meland E, Laerum E, Ulvik RJ. Effectiveness of two preventive interventions for coronary heart disease in primary care. Scand J Prim Health Care
1997;15:57–64.
70. Kuller L, Neaton J, Caggiula A, Falvo-Gerard L. Primary prevention of
heart attacks: the multiple risk factor intervention trial. Am J Epidemiol
1980;112:185–99.
71. Multiple Risk Factor Intervention Trial Research Group. Coronary heart
disease death, nonfatal acute myocardial infarction and other clinical
outcomes in the Multiple Risk Factor Intervention Trial. Am J Cardiol
1986;58:1–13.
72. Multiple Risk Factor Intervention Trial Research Group. Multiple risk
factor intervention trial. Risk factor changes and mortality results. JAMA
1982;248:1465–77.
73. Multiple Risk Factor Intervention Trial Research Group. Mortality rates
after 10.5 years for participants in the Multiple Risk Factor Intervention
Trial. Findings related to a priori hypotheses of the trial. JAMA 1990;263:
1795–801.
74. Hjermann I, Velve Byre K, Holme I, Leren P. Effect of diet and smoking
intervention on the incidence of coronary heart disease. Report from the
Oslo Study Group of a randomised trial in healthy men. Lancet 1981;2:
1303–10.
75. Holme I, Hjermann I, Helgeland A, Leren P. The Oslo Study: diet and
antismoking advice. Additional results from a 5-year primary preventive
trial in middle-aged men. Prev Med 1985;14:279 –92.
76. Imperial Cancer Research Fund OXCHECK Study Group. Effectiveness of
health checks conducted by nurses in primary care: results of the
OXCHECK study after one year. Imperial Cancer Research Fund OXCHECK Study Group. BMJ 1994;308:308 –12.
77. Stevens VJ, Corrigan SA, Obarzanek E, et al. Weight loss intervention in
phase 1 of the Trials of Hypertension Prevention. The TOHP Collaborative Research Group. Arch Intern Med 1993;153:849 –58.
78. Trials of Hypertension Prevention Collaborative Research Group. Effects
of weight loss and sodium reduction intervention on blood pressure and
hypertension incidence in overweight people with high-normal blood
pressure. Trials of Hypertension Prevention, phase II. Arch Intern Med
1997;157:657–67.
79. World Health Organization European Collaborative Group. European
collaborative trial of multifactorial prevention of coronary heart disease:
final report on the 6-year results. Lancet 1986;1:869 –72.
80. Wood PD, Stefanick ML, Dreon DM, et al. Changes in plasma lipids and
lipoproteins in overweight men during weight loss through dieting as
compared with exercise. N Engl J Med 1988;319:1173–9.
81. Baron JA, Gleason R, Crowe B, Mann JI. Preliminary trial of the effect of
general practice based nutritional advice. Br J Gen Pract 1990;40:137–41.
82. Lindholm LH, Ekbom T, Dash C, Eriksson M, Tibblin G, Schersten B. The
impact of health care advice given in primary care on cardiovascular risk.
CELL Study Group. BMJ 1995;310:1105–9.
83. Strandberg TE, Salomaa VV, Vanhanen HT, Naukkarinen VA, Sarna SJ,
Miettinen TA. Mortality in participants and non-participants of a multifactorial prevention study of cardiovascular diseases: a 28 year follow up of
the Helsinki Businessmen Study. Br Heart J 1995;74:449 –54.
84. Wilhelmsen L, Berglund G, Elmfeldt D, et al. The multifactor primary
prevention trial in Goteborg, Sweden. Eur Heart J 1986;7:279 –88.
85. Hypertension Detection and Follow-up Program Cooperative Group.
Five-year findings of the hypertension detection and follow-up program. I.
Reduction in mortality of persons with high blood pressure, including
mild hypertension. JAMA 1979;242:2562–71.
86. Hellenius ML, de Faire U, Berglund B, Hamsten A, Krakau I. Diet and
exercise are equally effective in reducing risk for cardiovascular disease.
Results of a randomized controlled study in men with slightly to moderately raised cardiovascular risk factors. Atherosclerosis 1993;103:81–91.
87. Morisky DE, Levine DM, Green LW, Shapiro S, Russell RP, Smith CR.
Five-year blood pressure control and mortality following health education
for hypertensive patients. Am J Public Health 1983;73:153–62.
88. Anderssen SA, Haaland A, Hjerman I, Urdal P, Gjesdal K, Holme I. Oslo
diet and exercise study: a one year randomized intervention trial. Effect
on haemonstatic variables and other coronary risk factors. Nutr Metab
Cardiovasc Dis 1995;5:189 –200.
89. Hjermann I, Holme I, Leren P. Oslo Study Diet and Antismoking Trial.
Results after 102 months. Am J Med 1986;80:7–11.
90. Glasgow RE, Terborg JR, Hollis JF, Severson HH, Boles SM. Take heart:
results from the initial phase of a work-site wellness program. Am J Public
Health 1995;85:209 –16.
91. World Health Organization European Collaborative Group. Multifactorial
trial in the prevention of coronary heart disease: 2. Risk factor changes at
two and four years. Eur Heart J 1982;3:184 –90.
92. World Health Organization European Collaborative Group. European
collaborative trial of multifactorial prevention of coronary heart disease:
final report on the 6-year results. Lancet 1986;i:869 –75.
93. Appel LJ, Champagne CM, Harsha DW, et al. Effects of comprehensive
lifestyle modification on blood pressure control: main results of the
PREMIER clinical trial. JAMA 2003;289:2083–93.
94. Ebrahim S. The use of numbers needed to treat derived from systematic
reviews and meta-analysis. Caveats and pitfalls. Eval Health Prof 2001;24:
152–64.
95. Campbell NC, Ritchie LD, Thain J, Deans HG, Rawles JM, Squair JL.
Secondary prevention in coronary heart disease: a randomised trial of
nurse led clinics in primary care. Heart 1998;80:447–52.
96. Campbell NC, Thain J, Deans HG, Ritchie LD, Rawles JM, Squair JL.
Secondary prevention clinics for coronary heart disease: randomised trial
of effect on health. BMJ 1998;316:1434 –7.
97. World Health Organization. Rehabilitation and comprehensive secondary
prevention after myocardial infarction. Copenhagen: World Health Organization, 1983.
98. DeBusk RF, Miller NH, Superko HR, et al. A case-management system for
coronary risk factor modification after acute myocardial infarction. Ann
Intern Med 1994;120:721–9.
99. Jones DA, West RR. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial. BMJ 1996;313:1517–21.
100. Frasure-Smith N, Lesperance F, Prince RH, et al. Randomised trial of
home-based psychosocial nursing intervention for patients recovering
from myocardial infarction. Lancet 1997;350:473–9.
101. Jolly K, Bradley F, Sharp S, et al. Randomised controlled trial of follow up
care in general practice of patients with myocardial infarction and angina:
final results of the Southampton heart integrated care project (SHIP).
The SHIP Collaborative Group. BMJ 1999;318:706 –11.
102. Fitzgerald JF, Smith DM, Martin DK, Freedman JA, Katz BP. A case
manager intervention to reduce readmissions. Arch Intern Med 1994;154:
1721–9.
103. Naylor MD, Brooten D, Campbell R, et al. Comprehensive discharge
planning and home follow-up of hospitalized elders: a randomized
clinical trial. JAMA 1999;281:613–20.
104. Naylor MD, McCauley KM. The effects of a discharge planning and home
follow-up intervention on elders hospitalized with common medical and
surgical cardiac conditions. J Cardiovasc Nurs 1999;14:44 –54.
105. Imperial Cancer Research Fund OXCHECK Study Group. Effectiveness of
health checks conducted by nurses in primary care: final results of the
OXCHECK study. Imperial Cancer Research Fund OXCHECK Study
Group. BMJ 1995;310:1099 –104.
106. Wonderling D, Langham S, Buxton M, Normand C, McDermott C. What
can be concluded from the Oxcheck and British family heart studies:
commentary on cost effectiveness analyses. BMJ 1996;312:1274 –8.
107. Wonderling D, McDermott C, Buxton M, et al. Costs and cost effectiveness
of cardiovascular screening and intervention: the British family heart
study. BMJ 1996;312:1269 –73.
108. Murchie P, Campbell NC, Ritchie LD, Simpson JA, Thain J. Secondary
prevention clinics for coronary heart disease: four year follow up of a
randomised controlled trial in primary care. BMJ 2003;326:84.
109. Glasgow RE, Hiss RG, Anderson RM, et al. Report of the health care
delivery work group: behavioral research related to the establishment of a
chronic disease model for diabetes care. Diabetes Care 2001;24:124 –30.
110. Funnell MM, Anderson RM. Working toward the next generation of
diabetes self-management education. Am J Prev Med 2002;22:3–5.
111. Diabetes Prevention Program Research Group. Reduction in the incidence of type-2 diabetes with lifestyle intervention or metformin. N Engl
J Med 2002;346:393– 403.
112. Gaede P, Vedel P, Larsen N, Jensen GVH, Parving H-H, Pedersen O.
Multifactorial intervention and cardiovascular disease in patients with
type–2 diabetes. N Engl J Med 2003;348:383–393.
113. Tuomilehto J, Lindstrom J, Eriksson JG, et al. Prevention of type–2
diabetes mellitus by changes in lifestyle among subjects with impaired
glucose tolerance. N Engl J Med 2001;344:1343–50.
114. Uusitupa M, Lindi V, Louheranta A, Salopuro T, Lindstrom J, Tuomilehto
J. Long-term improvement in insulin sensitivity by changing lifestyles of
Am J Prev Med 2004;27(2S)
77
115.
116.
117.
118.
119.
120.
121.
122.
123.
124.
125.
126.
127.
128.
129.
130.
131.
132.
78
people with impaired glucose tolerance: 4-year results from the Finnish
Diabetes Prevention Study. Diabetes 2003;52:2532–8.
Lindstrom J, Louheranta A, Mannelin M, et al. The Finnish Diabetes
Prevention Study (DPS): lifestyle intervention and 3-year results on diet
and physical activity. Diabetes Care 2003;26:3230 –6.
Lindstrom J, Eriksson JG, Valle TT, et al. Prevention of diabetes mellitus
in subjects with impaired glucose tolerance in the Finnish diabetes
prevention study: results from a randomized clinical trial. J Am Soc
Nephrol 2003;14:S108 –13.
Rose G. Sick individuals and sick populations. Int J Epidemiol 2001;30:
427–32.
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of
health promotion interventions. Am J Public Health 1999;89:1332–7.
Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework
for evaluating interventions: what can it tell us about approaches to
chronic illness management? Patient Educ Couns 2001;44:119 –27.
Glasgow RE, Bull SS, Piette JD, Steiner JF. Interactive behavior change
technology: a partial solution to the competing demands of primary care.
Am J Prev Med 2004;27(suppl 1):80 – 87.
Glasgow RE, Goldstein MG, Ockene JK, Pronk NP. Translating what we
have learned into practice: principles and hypotheses for interventions
addressing multiple behaviors in primary care. Am J Prev Med 2004;
27(suppl 1):88 –101.
Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA 2002;288:2469 –75.
Glasgow RE, Funnell MM, Bonomi AE, Davis C, Beckham V, Wagner EH.
Self-management aspects of the improving chronic illness care breakthrough series: implementation with diabetes and heart failure teams.
Ann Behav Med 2002;24:80 –7.
Glasgow RE, Davis CL, Funnell MM, Beck A. Implementing practical
interventions to support chronic illness self-management. Jt Comm J Qual
Saf 2003;29:563–74.
Goldstein MG, DePue J, Kazura A, Niaura R. Models for provider-patient
interaction: applications to health behavior change. In: Shumaker SA,
Schron E, Ockene JK, et al., eds. Handbook of health behavior change.
New York: Springer, 1998;85–113.
Glynn TJ, Manley MW. How to help your patients stop smoking. A
National Cancer Institute manual for physicians. Bethesda MD: Smoking,
Tobacco and Cancer Program, Division of Cancer Prevention and Control, National Cancer Institute, 1989 (NIH publication 89 –3064).
Ockene JK, Wheeler EV, Adams A, Hurley TG, Hebert J. Provider training
for patient-centered alcohol counseling in a primary care setting. Arch
Intern Med 1997;157:2334 –41.
Ockene JK, Ockene IS, Quirk ME, et al. Physician training for patientcentered nutrition counseling in a lipid intervention trial. Prev Med
1995;24:563–70.
Ockene JK, Adams A, Hurley TG, Wheeler EV, Hebert JR. Brief physicianand nurse practitioner-delivered counseling for high-risk drinkers: does it
work? Arch Intern Med 1999;159:2198 –205.
Noell J, Glasgow RE. Interactive technology applications for behavioral
counseling: issues and opportunities for health care settings. Am J Prev
Med 1999;17:269 –74.
Miller WR, Rollnick S. Motivational interviewing: preparing people for
change. 2nd ed. New York: Guilford Press, 2002.
Lorig KR, Holman H, Sobel DS, et al. Self-management education:
history, definition, outcomes, and mechanisms. Ann Behav Med 2003;26:
1–7.
133. Glasgow RE. Translating research to practice: lessons learned, areas for
improvement, and future directions. Diabetes Care 2003;26:2451–6.
134. DiMatteo MR. Enhancing patient adherence to medical recommendations. JAMA 1994;271:79, 83.
135. Roter D, Kinmonth A-L. What is the evidence that increasing participation
of individuals in self-management improves the processes and outcomes
of care? In: Williams R, Kinmonth A, Wareham N, Herman W, eds. The
evidence base for diabetes care. New York: John Wiley and Sons, 2002.
136. Safran D, Taira D, Rogers W, Kosinski M, Tarlov A. Linking primary care
performance to outcomes of care. J Fam Pract 1998;47:213–20.
137. Ockene JK, Zapka J. Changing provider behavior: provider education and
training. Tob Control 1997;6:S63–7.
138. Ockene JK, Ockene IS. Helping patients to reduce their risk for coronary
heart disease: an overview. In: Ockene IS, Ockene JK, eds. Prevention of
coronary heart disease. Boston: Little, Brown and Company, 1992;173–99.
139. Anderson R, Funnell M, Butler P, Arnold M, Fitzgerald J, Feste C. Patient
empowerment: results of a randomized controlled trial. Diabetes Care
1995;18:943–9.
140. Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate
patients with diabetes for glucose control. Diabetes Care 1998;21:1644 –
51.
141. Stange KC, Woolf SH, Gjeltema K. One minute for prevention: the power
of leveraging to fulfill the promise of health behavior counseling. Am J
Prev Med 2002;22:320 –3.
142. Cooper GS, Goodwin MA, Stange KC. The delivery of preventive services
for patient symptoms. Am J Prev Med 2001;21:177–81.
143. Wasson JH, Godfrey MM, Nelson EC, Mohr JJ, Batalden PB. Microsystems
in Health Care: Part 4. Planning Patient-Centered Care. Jt Comm J Qual
Saf 2003;29:227–37.
144. Lancaster T, Silagy C, Fowler G, Spiers I. Training health professionals in
smoking cessation (Cochrane Review). Oxford: Update Software, 1999.
145. Ockene IS, Hebert JR, Ockene JK, Merriam PA, Hurley TG, Saperia GM.
Effect of training and a structured office practice on physician-delivered
nutrition counseling: the Worcester-Area Trial for Counseling in Hyperlipidemia (WATCH). Am J Prev Med 1996;12:252–8.
146. Norris SL, Nichols PJ, Caspersen CJ, et al. Increasing diabetes selfmanagement education in community settings. A systematic review. Am J
Prev Med 2002;22:39 –66.
Appendix A
The Five A’s for Behavioral Counseling and
Health Behavior Change
This version of the 5A’s was adapted by CJ Peek, PhD, and
other members of the Planning Committee of the Addressing
Multiple Behavioral Risk Factors in Primary Care Project from
Whitlock P, Orleans CT, Pender N, Allan J. Evaluating
primary care behavioral counseling interventions: an evidence-based approach, Am J Prev Med 2002;22:267– 84.
Application: The content of each step in the Five A’s varies
from behavior to behavior, but clinical intervention targeting
any behavior change can be described with reference to these
five intervention components.
American Journal of Preventive Medicine, Volume 27, Number 2S
The Five A’s
Assess
Advise
Agree
Assist
Arrange
Ask about and assess behavioral health risks and factors that affect choice of behavior change goals and methods.
• Assessing behavioral risk factors identifies patients in need of intervention and provides basis for tailoring
brief interventions for maximum benefit.
• Assess beliefs, behaviors, knowledge, motivation, and past experience.
Give clear, specific, well-timed, and personalized behavior change advice, including information about personal
health harms and benefits.
• Clinician advice establishes behavioral issues as an important part of health care.
• Advise in a noncoercive, nonjudgmental manner that respects readiness for change and patient autonomy.
• Advice is most powerful when linked to the patient’s own health concerns, past experiences, family/social
situations, and person’s level of health literacy.
Collaboratively select appropriate goals and methods based on the patient’s interest in and willingness to change
the behavior.
• Collaborate to find common ground and to define behavior change goals and methods.
• Shared decision making is especially recommended for interventions that involve significant risk-benefit
tradeoffs.
• Shared decision making about behavior change results in a greater sense of personal control, choices based in
realistic expectations and patient values, improved patient adherence, and time saved in the exam room.
Using self-help resources and/or counseling, help the patient to achieve goals by acquiring skills, confidence, and
social and environmental supports for behavior change.
• Healthcare staff provide motivational interventions, address barriers to change, and/or secure support needed
for successful change.
• Effective interventions teach self-management and problem-solving or coping skills that enable patients to take
the next immediate steps toward targeted behavior change.
• An action plan is developed that lists goals, barriers and strategies, and specifies follow-up.
Schedule follow-up (in person or by phone) to provide ongoing assistance and support and to adjust the plan as
needed, including referral to more specialized intervention.
• Consider behavioral risk factors as chronic problems that change over time.
• Routine follow-up assessment and support through some kind of contact is usually necessary to promote and
maintain behavior change.
Am J Prev Med 2004;27(2S)
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