How Effective Were Lifestyle Interventions In Real-World Settings That Were Modeled On The Diabetes Prevention Program?
Rollins School of Public Health, Emory University, Atlanta, Georgia, USA. Health Affairs
(Impact Factor: 4.97).
01/2012; 31(1):67-75. DOI: 10.1377/hlthaff.2011.1009
We conducted a systematic review and meta-analysis of twenty-eight US-based studies applying the findings of the Diabetes Prevention Program, a clinical trial that tested the effects of a lifestyle intervention for people at high risk for diabetes, in real-world settings. The average weight change at twelve months after the intervention was a loss of about 4 percent from participants' baseline weight. Change in weight was similar regardless of whether the intervention was delivered by clinically trained professionals or lay educators. Additional analyses limited to seventeen studies with a nine-month or greater follow-up assessment showed similar weight change. With every additional lifestyle session attended, weight loss increased by 0.26 percentage point. We conclude that costs associated with diabetes prevention can be lowered without sacrificing effectiveness, using nonmedical personnel and motivating higher attendance at program sessions.
Available from: Sarah Abdi
- "Researchers then aimed to investigate the reproducibility of these interventions in real-world practice, which contrary to large controlled trials, is subject to several limitations such as limited resources and insufficient time. Some of the studies aimed at translating these interventions into real-world settings yielded promising results, particularly in reducing the incidence of type 2 diabetes and its risk factors11121314151617. However, a limited number of studies of translational behavioural lifestyle interventions for patients with type 2 diabetes have been conducted and have led to mixed results181920. "
Available from: Matthew J O'Brien
- "Based on our pilot data and findings from DPP  , we hypothesize that both the lifestyle intervention and metformin will result in significant weight loss relative to standard care. We chose Latinas as the target population because: 1) they have the highest risk of developing diabetes relative to Hispanic men and other demographic groups; 2) their culturally-shaped influence on family members' lifestyle behaviors may result in a multiplying effect of the study interventions;    and 3) previous DPP translation studies across all racial/ethnic groups have included mostly women, while citing challenges to engaging men . This paper presents the rationale, design, and baseline characteristics of this novel comparative effectiveness study, called the Promotora Effectiveness Versus Metformin Trial (PREVENT-DM). "
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ABSTRACT: Promotora Effectiveness Versus Metformin Trial (PREVENT-DM) is a randomized comparative effectiveness trial of a lifestyle intervention based on the Diabetes Prevention Program delivered by community health workers (or promotoras), metformin, and standard care. Eligibility criteria are Hispanic ethnicity, female sex, age ≥20 years, fluent Spanish-speaking status, BMI ≥23kg/m2, and prediabetes. We enrolled 92 participants and randomized them to one of the following three groups: standard care, DPP-based lifestyle intervention, or metformin. The primary outcome of the trial is the 12-month difference in weight between groups. Secondary outcomes include the following cardiometabolic markers: BMI, waist circumference, blood pressure, and fasting plasma glucose, hemoglobin A1C (HbA1c), total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and insulin. PREVENT-DM participants are socioeconomically disadvantaged Latinas with a mean annual household income of $15,527 ± 9,922 and educational attainment of 9.7 ± 3.6 years. Eighty-six percent of participants are foreign born, 20% have a prior history of gestational diabetes, and 71% have a first-degree relative with diagnosed diabetes. At baseline, PREVENT-DM participants had a mean age of 45.1 ± 12.5 years, weight of 178.8 ± 39.3lbs, BMI of 33.3 ± 6.5kg/m2, HbA1c of 5.9 ± 0.2%, and waist circumference of 97.4 ± 11.1cm. Mean baseline levels of other cardiometabolic markers were normal. The PREVENT-DM study successfully recruited and randomized an understudied population of Latinas with prediabetes. This trial will be the first U.S. study to test the comparative effectiveness of metformin and lifestyle intervention versus standard care among prediabetic adults in a “real-world” setting.
Available from: Bärbel Knäuper
- "The primary outcomes are the differences in mean percentage weight loss between the enriched and standard GLB at 3, 12, and 24 months. The recent systematic review and meta-analysis by Ali et al.  of all GLB studies conducted so far allowed for calculating the mean % weight loss achieved in studies with follow-ups at 3 months (N = 11 studies) and at 12 months (N = 16 studies). Results showed a mean percent weight loss from baseline of 4.37% at 3 months and 4.35% at 12 months. "
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The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals. However, one-on-one DPP sessions are costly. As a cost-saving alternative, a group version of the DPP, called Group Lifestyle Balance program (GLB), has been developed but has been shown to be less effective. The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, namely if-then plans and their mental practice, into the program.
A total of 154 participants will be randomized to a standard or enriched GLB program. For the enriched GLB program, if-then plans and their mental practice will be integrated into the standard GLB program. Participants will be overweight or obese men and women (BMI of 28 to 45 kg/m2, waist circumference ≥ 88 for women, ≥ 102 for men, 18 to 75 years of age) who do less than 200 minutes of self-reported moderate or vigorous exercise per week. Measures will be completed at baseline, 3 months, post-intervention (12 months), and 12 months post-intervention (24 months). The primary outcome measure is weight loss at 3, 12, and 24 months. Secondary outcomes include percent reaching weight loss goal, physical activity at 3, 12, and 24 months, and weight-related risk factors (waist circumference, hemoglobin A1c, systolic/diastolic blood pressure, total cholesterol/HDL ratio). Standardized training of the life-style coaches, use of standardized manuals, and audio taping and reviewing of the sessions will ensure intervention fidelity.
The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems. Ethical clearance has been received from the Research Ethics and Compliance Board of the Faculty of Medicine Research and Graduate Studies Office at McGill University (Montreal, Canada).
ClinicalTrials.gov Identifier: NCT02008435. Registered 6 December 2013.
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