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≥20years, 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±9922 and educational attainment of 9.7±3.6years. 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±12.5years, 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.
Original language | English (US) |
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Pages (from-to) | 320-327 |
Number of pages | 8 |
Journal | Contemporary Clinical Trials |
Volume | 45 |
DOIs | |
State | Published - Nov 1 2015 |
Funding
We would like to acknowledge the Diabetes Prevention Support Center (DPSC) of the University of Pittsburgh for training and support in the Group Lifestyle Balance Program; the current program is a derivative of this material. In particular, we would like to thank Elizabeth Venditti, PhD for her role in training our group and her ongoing support during implementation of the lifestyle intervention. We acknowledge the four promotoras delivering the lifestyle intervention in this study: Irma Zamora, Amarili Lopez, Rosalinda Hernandez, and Fabiola Carrasco. We would also like to thank the following people for their essential roles in implementing PREVENT-DM: Carol Homko, PhD; Barbara Schneider, MD; Michelle Nashleanas, MD; and Gonzalo Romero, MD. We are grateful for the many efforts of dedicated volunteers who helped with various aspects of the study. We would like to thank Maria Vargas, MPH for her help in preparing the manuscript for publication. Finally, we would like to recognize the PREVENT-DM participants for their time and dedication to this study. This study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases ( K23-DK095981 , O'Brien PI). We would also like to acknowledge other funders of this program, including the Kynett Foundation , the Claneil Foundation , and the Connelly Foundation . The funders played no role in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication.
Keywords
- Diabetes prevention
- Hispanic Americans
- Lifestylei intervention
- Metformin
- Obesity
ASJC Scopus subject areas
- Pharmacology (medical)