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Am J Prev Med. 2017 Jun;52(6):788-797. doi: 10.1016/j.amepre.2017.01.008. Epub 2017 Feb 22.

PREVENT-DM Comparative Effectiveness Trial of Lifestyle Intervention and Metformin.

Author information

1
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.
2
Puentes de Salud Health Center, Philadelphia, Pennsylvania; Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania.
3
Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
4
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.
5
Weight Watchers International, Inc., New York, New York.
6
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.
7
Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
8
Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania.

Abstract

INTRODUCTION:

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.

STUDY DESIGN:

RCT.

SETTING/PARTICIPANTS:

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.

INTERVENTION:

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.

MAIN OUTCOME MEASURES:

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.

PMID:
28237635
PMCID:
PMC5438762
DOI:
10.1016/j.amepre.2017.01.008
[Indexed for MEDLINE]
Free PMC Article

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