title: PREVENT-DM Comparative Effectiveness Trial of Lifestyle Intervention and Metformin.
abstract: BACKGROUND
  Although 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.
  
  
  METHODS
  RCT.
  
  
  METHODS
  Ninety-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.
  
  
  METHODS
  The 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.
  
  
  METHODS
  Weight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months.
  
  
  RESULTS
  ILI 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).
  
  
  CONCLUSIONS
  In 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.
authors.affiliation: Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Puentes de Salud Health Center, Philadelphia, Pennsylvania; Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Electronic address: matthew.obrien1@northwestern.edu.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: O'Brien
authors.affiliation: Puentes de Salud Health Center, Philadelphia, Pennsylvania; Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania.
authors.forename: Alberly
authors.initials: A
authors.lastname: Perez
authors.affiliation: Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Adam B
authors.initials: AB
authors.lastname: Scanlan
authors.affiliation: Puentes de Salud Health Center, Philadelphia, Pennsylvania; Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania.
authors.forename: Victor A
authors.initials: VA
authors.lastname: Alos
authors.affiliation: Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania; Department of Epidemiology and Biostatistics, College of Public Health, Temple University, Philadelphia, Pennsylvania.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Whitaker
authors.affiliation: Weight Watchers International, Inc., New York, New York.
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, Chicago, Illinois; Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Ronald T
authors.initials: RT
authors.lastname: Ackermann
authors.affiliation: Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Jody D
authors.initials: JD
authors.lastname: Ciolino
authors.affiliation: Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania.
authors.forename: Carol
authors.initials: C
authors.lastname: Homko
mesh_terms: D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006630:Hispanic or Latino / Q000706:statistics & numerical data; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008019:Life Style / Q000208:ethnology*; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D011236:Prediabetic State / Q000188:drug therapy* / Q000208:ethnology; D055105:Waist Circumference; D015431:Weight Loss
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin