A Pilot Study to Translate the Diabetes Prevention Program to Low Income Women

Principal Investigator: Abbey B. Berenson, MD

Co-Investigators: Karen Williams, PhD, Mahbubur Rahman, PhD, Dan Freeman, PhD, Elizabeth Reifsnider, PhD, Karen Williams, PhD, Helen Wu, PhD

The Diabetes Prevention Program (DPP) funded by NIDDK was implemented to compare the efficacy and safety of three interventions, 1) an intensive lifestyle intervention, 2) standard lifestyle recommendations combined with metformin, and 3) standard lifestyle recommendations with placebo. Differences were assessed between the three groups in the development of cardiovascular disease and its risk factors, changes in glycemia, ß-cell function, insulin sensitivity, obesity, physical activity, nutrient intake, health-related quality of life, and the occurrence of adverse events.

Participants in the DPP were encouraged to follow the food pyramid guidelines and to consume the equivalent of the National Cholesterol Education Program step 1 diet which advocates goals to 1) lose 5% to 10% of their initial weight through diet and exercise, 2) increase activity gradually with a goal of at least 30 minutes of an activity such as walking 5 days each week, and 3) avoid excessive alcohol intake. Smoking participants are encouraged to stop. Additionally, those randomized to the lifestyle intervention group were given goals and provided with ongoing support to help them achieve and maintain 1) a weight reduction of at least 7% of initial body weight through healthy eating, and 2) a level of physical activity of at least 150 minutes per week through moderate intensity activity, such as walking or bicycling. Among the three groups in the DPP study, the 10-year cumulative incidence of diabetes was lowest in the intensive lifestyle group. As a result the 2002 DM Interagency Coordinating Committee4, which met to identify priority areas for future research, recognized the critical need to translate the clinically significant findings from the DPP into real-world clinical settings.

Women are at high risk of Type 2 DM as over one-half of reproductive-age women in the US currently have a BMI >25 kg/m2. The DPP may provide an effective way to address this problem, but is too costly to use on a widespread basis. Thus, effective programs which can be incorporated into public clinics are critically needed. To fill this need, our multidisciplinary team of investigators will conduct a pilot study comparing two DPP-based interventions for weight loss and behavior change among young, low-income women receiving care in publicly funded clinics. UTMB’s network of maternal and child health clinics, which provide care to a large multi-ethnic low-income population, offers a unique opportunity to refine and test weight loss interventions in a population at high risk of Type 2 DM. Before initiating the pilot study, potential patients will help refine the interventions, thereby increasing our chance of obtaining extramural funding and the assuring the success of the project.