title: 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.
authors.affiliation: Center for Obesity Research and Education, Temple University, 3223 North Broad Street, Suite 175, Philadelphia, PA 19140, USA; Puentes de Salud Health and Wellness Center, 1700 South Street, Philadelphia, PA 19146, USA.
authors.forename: Alberly
authors.initials: A
authors.lastname: Perez
authors.affiliation: Center for Obesity Research and Education, Temple University, 3223 North Broad Street, Suite 175, Philadelphia, PA 19140, USA; Puentes de Salud Health and Wellness Center, 1700 South Street, Philadelphia, PA 19146, USA.
authors.forename: Victor A
authors.initials: VA
authors.lastname: Alos
authors.affiliation: Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Boulevard, Philadelphia, PA 19104, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Scanlan
authors.affiliation: Center for Obesity Research and Education, Temple University, 3223 North Broad Street, Suite 175, Philadelphia, PA 19140, USA; Puentes de Salud Health and Wellness Center, 1700 South Street, Philadelphia, PA 19146, USA.
authors.forename: Catarina M
authors.initials: CM
authors.lastname: Maia
authors.affiliation: Department of Epidemiology and Biostatistics, College of Public Health, Temple University, 1301 Cecil B. Moore Avenue, Ritter Annex, 9th Floor, Philadelphia, PA 19122, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Davey
authors.affiliation: Center for Obesity Research and Education, Temple University, 3223 North Broad Street, Suite 175, Philadelphia, PA 19140, USA; Department of Epidemiology and Biostatistics, College of Public Health, Temple University, 1301 Cecil B. Moore Avenue, Ritter Annex, 9th Floor, Philadelphia, PA 19122, USA.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Whitaker
authors.affiliation: Weight Watchers International, Inc., 675 Avenue of the Americas, 6th Floor, New York, NY 10010, USA.
authors.forename: Gary D
authors.initials: GD
authors.lastname: Foster
authors.affiliation: Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL 60611, USA; Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, 6th Floor, Chicago, IL 60611, USA.
authors.forename: Ronald T
authors.initials: RT
authors.lastname: Ackermann
authors.affiliation: Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL 60611, USA; Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, 6th Floor, Chicago, IL 60611, USA. Electronic address: matthew.obrien1@northwestern.edu.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: O'Brien
mesh_terms: D000328:Adult; D001786:Blood Glucose; D001794:Blood Pressure; D015992:Body Mass Index; D003150:Community Health Workers / Q000458:organization & administration; D057186:Comparative Effectiveness Research; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D004032:Diet; D015444:Exercise; D005260:Female; D006442:Glycated Hemoglobin; D015438:Health Behavior / Q000208:ethnology; D006293:Health Promotion / Q000379:methods*; D006630:Hispanic or Latino; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008019:Life Style; D008055:Lipids / Q000097:blood; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D011236:Prediabetic State / Q000188:drug therapy / Q000628:therapy*; D012107:Research Design; D012307:Risk Factors; D012959:Socioeconomic Factors; D014481:United States; D055105:Waist Circumference; D061217:Weight Reduction Programs / Q000458:organization & administration
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008055:Lipids; D008687:Metformin
keywords: Diabetes prevention; Hispanic Americans; Lifestylei intervention; Metformin; Obesity