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To determine whether lifestyle intervention or the drug metformin would prevent or delay the onset of diabetes
Eligibility criteria included an age of at least 25 years, a body mass index (BMI) of 24 or higher (22 or higher in Asians), a plasma glucose concentration of 95 to 125 mg per deciliter in the fasting state (<125 mg per deciliter in the American Indian clinics), and 140 to 199 mg per eciliter two hours after a 75 g oral glucose load
1996 – 2002
The average follow-up of participants was 2.8 years. The incidence of diabetes was 11.0, 7.8, and 4.8 cases per 100 person-years in the placebo, metformin, and lifestyle groups, respectively. The lifestyle intervention reduced the incidence by 58 percent and metformin by 31 percent, is compared with placebo. To prevent one case of diabetes during a period of three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin.
The Diabetes Prevention Program (DPP) was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health.
Twenty-seven community health centers throughout the United States; National Institutes of Health; NIDDK; National Institute of Child Health and Human Development; National Institute on Aging; National Center on Minority Health and Health Disparities; National Center for Research Resources General Clinical Research Center Program; Office of Research on Women's Health; Indian Health Service; Centers for Disease Control and Prevention (CDC); American Diabetes Association; Bristol-Myers Squibb; Lipha Pharmaceuticals; Parke-Davis; Accusplit; LifeScan; Health O Meter; Hoechst Marion Roussel; Medco Managed Care; Merck and Co.; Nike Sports Marketing; Slim Fast Foods; Quaker Oats; McKesson BioServices; Matthews Media Group; Henry M. Jackson Foundation
Both the lifestyle intervention and metformin were effective in decreasing the incidence of diabetes. Lifestyle intervention decreased the incidence of Type 2 diabetes by 58 percent, compared with 31 percent for the metformin-treated group.16 The lifestyle intervention included face-to-face counseling for each participant over the course of 20 to 24 weeks, including individual accountability through a private weigh-in and development of individual action plans.
The DPP used a goal-based intervention to achieve loss and maintenance of 7 percent of baseline body weight. The recommended pace of weight loss was one to two pounds per week. Lifestyle goals included modest dietary restriction and at least 150 minutes per week of moderate-level physical activity. The primary approach to diet restriction involved a recommendation for low fat (<25 percent fat) intake. If fat restriction did not produce weight loss to goal, calorie restriction was also recommended. Brisk walking was emphasized to achieve the activity goal, but any activity of similar intensity could be applied to the goal. Although most participants completed activities on their own, two supervised exercise classes were offered each week.
Each participant in the lifestyle group was assigned an individual case manager or lifestyle coach, who followed a structured intervention protocol to help the participant achieve and maintain lifestyle goals. The core of the intervention involved a structured, face-to-face, 16‑lesson curriculum that was completed over 20 to 24 weeks. Lessons ranged from 30 minutes to one hour and included a private weigh-in, review of self-monitoring records, presentation of a new topic, identification of personal barriers to weight loss and activity, and development of an action plan for the next session.
The DPP was successful in proving the efficacy of intensive lifestyle interventions to reduce the risk of developing Type 2 diabetes. Because of the one-on-one counseling with highly qualified personnel and intensive programming involved, the program is expensive and difficult to replicate cost-effectively. Since 2002, there have been a variety of efforts to modify the core DPP curriculum to make the lessons more widely available at a lower cost. Some examples include an adaptation for YMCA centers in Indiana and the CDC's current Diabetes Primary Prevention Initiative in five states.
http://diabetes.niddk.nih.gov/dm/pubs/preventionprogram