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An Adaptation of the Diabetes
Prevention Program for Use
With High-Risk, Minority
Patients With Type 2 Diabetes
Purpose
J. Steven Cramer, MD, MS
The purpose of this pilot study was to determine the effectiveness of an edited Diabetes Prevention Program (DPP)
Lifestyle Resources Core Teaching Plan for managing
patients with type 2 diabetes in an urban underserved setting. Modifications were made to attempt to cut to the bare
essentials to work within the constrained budgets of safety
net providers. The primary aim was to achieve a mean
absolute reduction in HbA1c level of 1 percentage point.
Methods
The authors conducted a randomized controlled trial of
9 months’ duration for patients with type 2 diabetes with
an HbA1c ≥8.0%. A total of 67 patients randomized into
usual-care and case management groups were evaluated
with an intention-to-treat analysis. A modified DPP
workbook was used during 7 monthly visits with a nurse
case manager.
Results
As compared with the usual-care group, those in the case
management group experienced a greater reduction in
HbA1c level (–1.87 vs –0.54; P = .011) and weight
(–2.47 kg vs +0.88 kg; P = .011).
Ralph F. Sibley, PhD, MS
Donald P. Bartlett, PhD
Linda S. Kahn, PhD
Lisa Loffredo, RN
From the Department of Family Medicine, School of
Medicine and Biomedical Sciences, State University
of New York at Buffalo (Dr Cramer, Dr Sibley,
Dr Bartlett, Dr Kahn), and Kaleida Health, Buffalo,
New York (Ms Loffredo).
Correspondence to J. Steven Cramer, MD, MS,
Department of Family Medicine, School of Medicine
and Biomedical Sciences, State University of New
York at Buffalo, 2447 Sheridan Drive, Tonawanda, NY
14150 ([email protected]).
Acknowledgments: This project was funded by a
grant from the Kaleida Foundation, Buffalo, New York.
We wish to thank Dr Anne Tilghman Brenneman,
project coordinator for the Diabetes Prevention
Program, for permission to publish this abbreviated
version of the Diabetes Prevention Program manual.
DOI: 10.1177/0145721707301680
Conclusion
Use of an edited version of the DPP workbook in an urban,
low-income, minority population with type 2 diabetes
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produced a significant absolute reduction in HbA1c
percentage and weight.
R
ecent work has confirmed the power of
lifestyle interventions in reducing the
incidence of diabetes in high-risk individuals. The Diabetes Prevention Program
(DPP) demonstrated that the introduction
of a healthy low-fat diet and physical activity of moderate intensity for at least 150 minutes per week in conjunction with a weight loss goal of 7% resulted in a 58%
reduction in progression to diabetes when compared with
the usual-care group.1
Case management has been shown to reduce the cost
of care for high-risk groups. Hospital admissions are
avoided and/or length of stay shortened.2 The Task Force
on Community Preventive Services, an independent, nongovernmental panel, strongly recommended case management to improve outcomes based on their comprehensive
systematic review.3
It remains uncertain, however, whether case management is better delivered with or without disease management.4 Specific additional interventions that augment the
effectiveness of disease and case management need to be
identified. How intense interventions should be and how
best to integrate them into the existing health care systems
are still open questions.3
Description of Project
To address these concerns, a case management project
was developed for high-risk, minority patients with type 2
diabetes, incorporating 2 protocols: the DPP teaching plan5
and an evidence-based, accelerated, medical management
algorithm.6 The study was designed as a 9-month randomized controlled trial for patients with type 2 diabetes. The
Institutional Review Board of the university approved the
study, and all participants gave written informed consent.
Sixty-seven patients were recruited from family medicine
clinics serving a predominately minority population with a
total of approximately 35 000 visits per year in inner-city
Buffalo, New York.7 Participants were randomly assigned
to either the nurse case management condition or to a
usual-care control group.
Inclusion criteria were a diagnosis of type 2 diabetes,
age greater than 18 years, not pregnant and not planning on
pregnancy in the next 12 months, HbA1c level within the
past 6 months ≥8.0%, and the ability to perform self-care.
Patients on insulin were included as were Spanish-speaking
patients. Exclusion criteria included any documented psychiatric diagnosis, alcohol or substance abuse, seizure disorder, myocardial infarction within the past 3 months,
unstable angina, inability to attend the clinic for routine
visits, and not having a telephone.
Follow-up visits with a nurse case manager were
scheduled monthly. Interventions for diet, weight loss,
exercise, and lifestyle changes were managed using the
DPP Lifestyle Resources Core Teaching Plan. The goals
of the intervention were to achieve increased activity levels, a weight loss of 7%, and an appropriate modification
of the patient’s diet. This approach to insulin resistance in
the DPP seemed an appropriate fit with the natural history
of type 2 diabetes.
Components of the DPP program were selected to
address this focus and to allow for completion in 7 visits.8
The evidence-based medication algorithm was developed
by the Institute for Clinical Systems Improvement (ICSI)
to help providers with a structured logical progression of
medication changes to improve their patients’ diabetic care.
Description of the DPP
The DPP Lifestyle Change Participant Notebook originally consisted of a core curriculum of 16 modules to be
implemented over a 24-week period with monthly followups for the remaining years of the study. The DPP Lifestyle
program was developed as part of a landmark multicenter
randomized clinical trial comparing metformin hydrochloride (Glucophage®; Bristol-Myers Squibb, New York, NY)
to an intensive behavioral intervention focused on diet and
exercise. The success of this study was compelling. The
generalizability of the findings was strengthened by the
diversity of the study population (45% were racial and ethnic minorities). The DPP Lifestyle program was supported
by extensive resource materials including guidance for
group interventions, motivational classes, and a collection
of toolbox techniques to customize treatment during and
after the standardized program. In addition, there was
extensive supervised training for case managers to ensure
competence and standardization.
Despite the robust success of the DPP, it remained
much too costly and time-consuming for a small clinic or
hospital system to implement in its full form. The objective of this study was to edit the manual and the relevant
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Modifications to the DPP Lifestyle Workbook7
DPP PARTICIPANT NOTEBOOK:ORIGINAL
NOTEBOOK: ORIGINALFORMAT
FORMAT*
*
Modified DPP Format
Session
Topic
Visit
Modules Covered
1A
Welcome to the Lifestyle Balance Program
1
1B
Getting Started Being Active
•Welcome to the Lifestyle Balance Program
•Getting Started Being Active
•Move Those Muscles
1B
Getting Started Losing Weight
2
•Being Active: A Way of Life
2 or 5
Move those Muscles
3
•Getting Started Losing Weight
3 or 6
Being Active: A Way of Life
4
4 or 2
Be a Fat Detective
•Be a Fat Detective
•Three Ways to Eat Less Fat
5 or 3
Three Ways to Eat Less Fat
5
6 or 4
Healthy Eating
•Healthy Eating
•Take Charge of What's Around You
7 or 8
Take Charge of What's Around You
6
•Four Keys to Healthy Eating Out
7
•The Slippery Slope of Lifestyle Change
8 or 7
Tip the Calorie Balance
9
Problem Solving
10
Four Keys to Healthy Eating Out
11
Talk Back to Negative Thoughts
12
The Slippery Slope of Lifestyle Change
13
Jump Start Your Activity Plan
14
Make Social Cues Work for You
15
You Can Manage Stress
16
Ways to Stay Motivated
* Adapted From: DPP Lifestyle Prevention website: http://www.bsc.gwu.edu/dpp/lifestyle/dpp_part.html
Figure 1. Modifications to the Diabetes Prevention Program (DPP) Lifestyle Workbook.7 Adapted from the DPP Lifestyle Prevention Web site:
http://www.bsc.gwu.edu/dpp/lifestyle/dpp_part.html. Published with permission from Dr Anne Tilghman Brenneman.
support procedures into a resource-efficient intervention
that, if effective, could be realistically used by community clinics for both patients at risk for type 2 diabetes
and those who had already developed the disorder.
participant handbook and appropriately modified provider
script. The manual for this revised DPP program is available
on the University at Buffalo Family Medicine Web site.8
Schedule of Visits
The Revised DPP
The edited version focuses on the following core areas:
provision of basic knowledge regarding diabetes and its
complications, individual goal setting for diet and exercise,
basic education regarding the calorie and fat content of various foods, guidance in choosing exercises appropriate to
age and physical condition, techniques for self-monitoring,
specific strategies for shopping and eating out, relapse
prevention, and individual coaching to monitor progress,
address obstacles, and increase motivation (see Figure 1).
The edited version consists of a 7-module (51-page)
The first visit focused on education on the diabetes disease process and the associated risk of complications. At
this session, patients also completed a physical activity
questionnaire9 and a dietary questionnaire (see Figure 2).
Initial feedback from patients showed a lack of knowledge of the disease, especially the high risk for major
complications, such as renal failure, cardiovascular disease, and blindness. Achieving greater understanding of
the long-term effects of uncontrolled diabetes appeared
to motivate the participants to seek knowledge of how
to improve compliance and reduce associated risks.
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Dietary Questionnaire
For each question, mark the item indicating how often, on average, you have eaten the items during the past year.
Remember to include the things that you cook with.
< Once a
week
Items Eaten
Broccoli, cauliflower,
cabbage, brussels sprouts
Other vegetables
(peas, corn, tomatoes, etc)
Citrus fruits (oranges,
grapefruits, fruit juice)
Other fruits (apples,
bananas, berries, etc)
Whole milk dairy food
(whole milk, hard cheese)
Low-fat dairy products
(skim milk, butter, etc)
Once a
week
2-4 times a
week
Nearly daily
or daily
Twice or
more a day
Whole eggs
Fats (margarine, salad
dressing, oils, butter, etc)
Whole grains (whole grain breads,
brown rice)
Pasta, rice, noodles
Baked goods (donuts, cookies,
pastries)
Beef, pork, or lamb
Processed meats (hotdogs, lunch
meat, bacon)
Fish or seafood (not fried, but broiled
or baked)
Deep fried foods (chicken wings,
French fries)
Alcoholic beverages (wine, beer,
liquor)
Soda pop or sweetened drinks
(lemonade, etc)
Sweets (candy, chocolate, ice cream)
Figure 2. Dietary questionnaire.
Following the overview of the diabetes disease process, the
calorie, sugar, and fat content of various food groups was
reviewed. This focused on each food group’s effect on
blood glucose levels and cardiovascular risk. In addition,
suggested serving sizes were reviewed.
The DPP includes culturally specific food pyramids.
For the African American community, which represents
most current study participants, the Southern food pyramid
was used. It offers many culturally specific foods, allowing the clients to identify with familiar food choices. The
Hispanic food pyramid, which was developed for a
Mexican American rather than a Puerto Rican population, was not useful because of the patients’ unfamiliarity with the listed foods.
After the initial educational visit, participants returned
to the clinic monthly for individual meetings. They
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received phone calls every 2 weeks between meetings to
offer support with diet and exercise, review progress, monitor blood glucose levels, review medication compliance,
and monitor compliance with health care provider visits.
Attempts were made to have monthly meetings coincide
with health provider appointments. This allowed communication between the case management nurse and provider
and improved compliance by the patient.
During the second and third visits, the revised DPP
sessions focused on increasing activity. Participants were
encouraged to increase their activity intensity to the
equivalent of brisk walking while attempting to reach 150
min/wk in duration. Participants were actively involved in
developing their own exercise plans and setting their own
goals. Tracking of activity was encouraged, and each participant was given a log to track his or her participation,
selected activity, and duration.
The following 4 visits focused on weight loss, with a
primary focus on reducing fat intake, while continuing
to encourage increased physical activity. In promoting
lifestyle change for diet, participants were actively involved
in identifying current poor dietary habits and setting realistic goals to change those behaviors. The notebook gave
healthy suggestions on recipe alternatives, low-fat alternatives for snacking and meals, and fast food choices.
Participants identified their own goals in reducing fat
intake and limiting sugar intake.
During the eighth visit (seventh and final formal
teaching session), the program emphasized the importance of staying on track, handling setbacks, and maintaining a healthier lifestyle. At this visit, patients again
completed the physical activity and diet questionnaires.
Feedback from participants during this final session was
very positive. They identified the food pyramid as a beneficial tool in understanding what to eat and what to avoid.
The social support of a nurse was also beneficial, offering
frequent contact, continued encouragement, and motivation. Participants stated that “it was comforting to know
that I could call if I needed something or had a question”
and “it was much more helpful to have someone spend
time with me, other than getting handed a packet to read.”
Findings
The goals of this study were to increase patients’
activity levels, help them achieve a 7% weight loss, and
help them make healthier food choices.
Activity was measured by the International Physical
Activity Questionnaire,9 which was completed at the first
and last monthly visit. Patients were asked how many
days they walked for at least 10 minutes in the previous
7 days and to estimate how much time (hours or minutes)
they usually spent walking on those days.
Walking increased in the intervention group by an average of 34 (±54) minutes per week and decreased by 19
(±18) minutes per week in the usual-care group. However,
the intergroup difference was not significantly different
(P = .08 by t test).
Case management participants experienced a mean
weight change of –2.47 (±1.87) kg, while patients in the
usual-care group gained 0.88 (±1.84) kg on average.
Although this difference is statistically significant (P =
.01 by t test), the average weight loss in the intervention
group was only 2.69%, well below the goal of 7%. This
result is, however, compatible with results from similar
studies.
Eating habits were evaluated by means of a dietary
questionnaire (Figure 2). Patients were asked to estimate
how often over the past year they had eaten foods in 18
categories. Scores ranging from 1 to 5 were assigned to
each category, with a maximum score of 5 given for the
highest frequency (twice or more a day) for healthy foods
(eg, fruits) and for the lowest frequency (<once a week)
for unhealthy foods (eg, deep-fried foods). Complete prequestionnaires and postquestionnaires were available for
27 participants in the intervention group and 24 patients in
the usual-care group.
All 27 participants in the case management group
showed an increase in their average ratings over the course
of the study, indicating change in a healthy direction. Only
5 of the usual-care patients showed positive changes, while
16 had lower scores and 3 were unchanged. The difference
between groups is statistically significant (P < .001 by χ2).
Blood glucose levels were also compared in the 2
groups over the course of the study. Absolute HbA1c percentage fell an average of 1.87 (±0.81) points in the
treated group and 0.54 (±0.55) points in the usual-care
group (P = .011 by t test). As noted above, all patients,
regardless of group assignment, received diabetes medication according to the ICSI guidelines. Intensity of medical
management, defined as any change in dosing or addition
of diabetes medication, including insulin, was monitored
in both groups to determine whether this might have differentially influenced glycemic control. No statistically
significant differences were found between the groups on
this measure. In addition, no significant differences were
found between the groups in the percentage taking insulin
at baseline and postintervention.
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Relevance for Diabetes
Educators
Use of the provided DPP activity and diet-tracking
logs proved ineffective. Literacy and language barriers
appeared to be the largest limiting factor in this component of the DPP program, requiring the case manager to
go over items orally with the participant during each session. Despite this, pre-post review of evaluative tools for
diet and activity confirmed more positive change in the
active treatment group than in the control population.
Using the modified DPP in this clinical setting proved
successful in allowing participants an active role in changing their lifestyle. The program was implemented in a
health-disparity primarily African American population,
whose diabetes was poorly controlled, as evidenced by an
initial HbA1c level greater than 8%.
biopsychosocial morbidity and would be expected to better
respond to systems designed to promote more comprehensive patient-centered care.13 The DPP workbook, as
currently modified for use in patients with type 2 diabetes,
in conjunction with face-to-face contact with a nurse case
manager, appears to be an effective way to provide comprehensive diabetes care for health disparity populations
attending primary care clinics.
References
1.
2.
3.
4.
Discussion
This exploratory study has shown that case management using a modified DPP workbook was successful in
achieving significant weight loss and positive dietary
change in this population of low-income minority patients
with type 2 diabetes.
The 1.33 percentage point net improvement in HbA1c
level, if maintained, would predict a 40% reduction in
the microvascular complications of diabetes.10 Achieving
an absolute risk reduction of 13.22% would yield a number needed to treat (NNT) of 8 for 9 months, consistent
with the DPP NNT of 6.9 for 3 years.1
Although weight loss in the case management group
amounted to only 2.49% (the target was 7%), it was
compatible with results from similar studies.11 While the
duration of walking for the case management patients
increased only 34 minutes to a mean of 90 minutes per
week (the target was 150 minutes), it was an improvement compared with the decrease in activity seen in the
usual-care participants.
The safety net providers for this population of primarily
poor African Americans are routinely presented with clinical, logistical, paperwork, and administrative challenges.
Limited resources, reduced reimbursements, and high noshow rates currently endanger their continuing ability to
provide care.12,13 These patients present with greater
5.
6.
7.
8.
9.
10.
11.
12.
13.
DPP Program Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med.
2002;346:393-403.
Berg GD, Wadhwa S. Diabetes disease management in a
community-based setting. Manag Care. 2002:11:42-49.
Task Force on Community Preventive Services. Recommendations
for healthcare system and self-management education interventions to reduce morbidity and mortality from diabetes. Am J Prev
Med. 2002;22(4 suppl):10-14.
Norris SL. The effectiveness of disease and case management for
people with diabetes: a systematic review. Am J Prev Med. 2002;
22(4 suppl):15-38.
DPP Program Group. DPP lifestyle materials for sessions 1-16.
Available at: http://www.bsc.gwu.edu/dpp/lifestyle/dpp_part.html.
Accessed October 28, 2006.
Institute for Clinical Systems Improvement. ICSI health care
guideline: management of type 2 diabetes mellitus. Available at:
http://www.icsi.org/knowledge/detail.asp?catID=29&itemID=182.
Accessed October 28, 2006.
Hemiup JT, Carter CA, Fox CH, et al. Correlates of obesity
among patients attending an urban family medical center. J Natl
Med Assoc. 2005;97:1642-1648.
Intensive Nurse Case Management. DPP modified lifestyle change
participant notebook and instructor scripts for intensive nurse case
management of diabetes. Available at: http://fammed.buffalo.edu/
intensiveNurseCM.html. Accessed October 28, 2006.
International Physical Activity Questionnaire. Guidelines for data
processing and analysis of the International Physical Activity
Questionnaire (IPAQ)—short form [article online]. Available at:
http://www.ipaq.ki.se. Accessed October 27, 2006.
NCQA. Comprehensive diabetes care: state of health care quality
report [article online]. Available at: http://www.ncqa.org/sohc2003/
comprehensive_diabetes_care.htm. Accessed October 27, 2006.
Wolf A, Conaway MR, Crowther JQ, et al. Translating lifestyle
intervention to practice in obese patients with type 2 diabetes:
Improving Control With Activity and Nutrition (ICAN) study.
Diabetes Care. 2004;27:1570-1576.
Winocour PH. Effective diabetes care: a need for realistic targets.
BMJ. 2002;321:1577-1580.
Fiscella K, Williams DR. Health disparities based on socioeconomic inequities: implications for urban health care. Acad Med.
2004;79:1139-1147.
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