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The rationale, design, and baseline characteristics of PREVENT-DM: A community-based comparative effectiveness trial of lifestyle intervention and metformin among Latinas with prediabetes.

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 ? 23 kg/m(2), 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 ± 9922 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 ± 39.3 lbs, BMI of 33.3 ± 6.5 kg/m(2), 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.

SUBMITTER: Perez A

PROVIDER: S-EPMC4674352 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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The rationale, design, and baseline characteristics of PREVENT-DM: A community-based comparative effectiveness trial of lifestyle intervention and metformin among Latinas with prediabetes.

Perez Alberly A Alos Victor A VA Scanlan Adam A Maia Catarina M CM Davey Adam A Whitaker Robert C RC Foster Gary D GD Ackermann Ronald T RT O'Brien Matthew J MJ

Contemporary clinical trials 20151024 Pt B

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 ≥ 23 kg/m(2), and prediabetes. We enrolled 92 participants and randomized them to one of the following three groups: standard car ...[more]

PMID: 26597415

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Project description:IntroductionAlthough the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions (ILI) and metformin to prevent type 2 diabetes, no studies have tested their comparative effects in pragmatic settings. This study was designed to compare the real-world effectiveness of ILI, metformin, and standard care among Hispanic women (Latinas) with prediabetes.Study designRCT.Setting/participantsNinety-two Latinas, who had a mean hemoglobin A1c of 5.9%, BMI of 33.3 kg/m2, and waist circumference of 97.4 cm (38.3 inches), were recruited from an urban community and randomly assigned to ILI, metformin, or standard care using 1:1:1 allocation. Data were collected from 2013-2015 and analyzed in 2016.InterventionThe 12-month ILI was adapted from the Diabetes Prevention Program's ILI and delivered by community health workers (promotoras) over 24 sessions. Metformin participants received 850 mg twice daily. Those randomized to standard care continued their regular medical care.Main outcome measuresWeight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months.ResultsILI participants demonstrated significantly greater mean weight loss (-4.0 kg, 5.0%) than metformin (-0.9 kg, 1.1%) and standard care participants (+0.8 kg, 0.9%) (p<0.001). The difference in weight loss between metformin and standard care was not significant. The ILI group experienced a greater reduction in waist circumference than standard care (p=0.001), and a marginal improvement in hemoglobin A1c compared with metformin and standard care (p=0.063).ConclusionsIn the first comparative effectiveness trial of diabetes prevention treatments, a 12-month ILI produced significantly greater weight loss than metformin and standard care among Latinas with prediabetes. These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group, which may be superior to metformin. Future pragmatic trials involving larger samples should examine differences in diabetes incidence associated with these treatments.

Project description:BackgroundChildhood obesity has been increasing rapidly worldwide. There is limited evidence for effective lifestyle interventions to prevent childhood obesity worldwide, especially in developing countries like China. The objective of this study was to assess the effectiveness of a school-based multi-component lifestyle childhood obesity prevention program (the CLICK-Obesity study) in Mainland China.MethodsA cluster randomized controlled trial was developed among grade 4 students from 8 urban primary schools (638 students in intervention, 544 as control) in Nanjing City, China. Students were randomly allocated to the control or intervention group at school-level. A one-year multi-component intervention program (classroom curriculum, school environment support, family involvement and fun programs/events) together with routine health education was provided to the intervention group, while the control group received routine health education only. The main outcome variables assessed were changes in body mass index, obesity occurrence, obesity-related lifestyle behaviors and knowledge.ResultsOverall, 1108 (93.7%) of the 1182 enrolled students completed the intervention study. The intervention group had a larger marginal reduction than did the control group in overall mean BMI value (-0.32±1.36 vs. -0.29±1.40, p = 0.09), although this was not significant. Compared with the control group, the intervention group was more likely to decrease their BMI (OR = 1.44, 95%CI = 1.10, 1.87) by 0.5 kg/m2 or above, increase the frequency of jogging/running (OR = 1.55, 95%CI = 1.18, 2.02), decrease the frequency of TV/computer use (OR = 1.41, 95%CI = 1.09, 1.84) and of red meat consumption (OR = 1.50, 95%CI = 1.15, 1.95), change commuting mode to/from school from sedentary to active mode (OR = 2.24, 95%CI = 1.47, 3.40), and be aware of the harm of selected obesity risk factors.ConclusionsThe school-based lifestyle intervention program was practical and effective in improving health behaviors and obesity-related knowledge for children in China. This study provides important policy implications on school-based intervention programs for modifications of obesity-related lifestyles.Trial registrationChinese Clinical Trial Registry ChiCTR-ERC-11001819.

Dataset Information

The rationale, design, and baseline characteristics of PREVENT-DM: A community-based comparative effectiveness trial of lifestyle intervention and metformin among Latinas with prediabetes.

Publications

The rationale, design, and baseline characteristics of PREVENT-DM: A community-based comparative effectiveness trial of lifestyle intervention and metformin among Latinas with prediabetes.

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