Community-Based Health Intervention Provides Weight Loss and Improvement in Glucose

David C. Goff, Jr., MD, chair of the Department of Epidemiology and Prevention at Wake Forest University School of Medicine in Winston-Salem, North Carolina explained that the Healthy Living Partnership to Prevent Diabetes (HELP-PD) helped 301 overweight or obese adults with prediabetes reduce their body weight by more than 7% on average, and reduce waist circumference by about 5 cm in 1 year.

"Our reduction in glucose of 4 mg/dL is comparable to the DPP and to the Finnish Diabetes Prevention Study. Those differences were associated with about a 50% reduction in the incidence of diabetes, so we believe this is a clinically meaningful reduction in glucose. We also had substantial reductions in insulin and in the homeostasis model assessment for insulin resistance [HOMA-IR]," reported Dr. Goff.

HELP-PD is a randomized trial based in Forsyth County, North Carolina. It tests a group-based rather than individual-oriented behavioral lifestyle-change strategy with the goal of weight loss and diabetes prevention. Control subjects receive usual care.

The program is delivered through local diabetes care centers by registered dietitians and community health workers, who are diabetes patients identified as good candidates for training and group leadership. Initial participation in the study was planned for 2 years, and the investigators have recently received funding from the National Institute of Diabetes and Digestive and Kidney Diseases for extended follow-up.

Participants are 21 years or older with a body mass index (BMI) from 25 to 40 kg/m², 2 fasting glucose readings from 95 to 125 mg/dL, and no previous diagnosis of diabetes or cardiovascular disease.

The participants were randomized to the support group or usual care. The support group had 3 sessions with a registered dietitian during the first 6 months, and attended group meetings led by lay community health workers focused on weight loss, physical activity, and nutrition. The meetings were held weekly for the first 6 months, then monthly for the 18-month maintenance phase. The usual-care group had 2 sessions with a registered dietitian during the first 3 months, and received monthly newsletters about community resources for weight loss.

The primary end point is fasting glucose. Other end points are change in weight, percentage of body weight, BMI, waist circumference, fasting glucose, insulin, and HOMA-IR over the first year based on measures at 6 and 12 months.

At 12-month follow-up, mean fasting glucose had declined to a significantly greater degree in the support group than in the usual-care group (–4.2 mg/dL vs +0.3 mg/dL; P < .001).

At the same time, the support group had lost a mean of 7.1 kg, compared with 1.5 kg for the usual-care group (P < .001). The mean weight loss was 7.3% for the support group and 1.3% for the usual-care group (P < .001).

There were also significant differences in BMI changes (–2.2 kg/m² vs +0.3 kg/m²; P < .001), waist circumference (–5.9 cm vs –0.8 cm), fasting insulin (–6.6 µU/mL vs –2.7 µU/ml; P < .001), and fasting HOMA-IR (P < .001).

There were no significant differences in serious adverse events or incident diabetes, defined as a fasting glucose level above 126 mg/dL or use of diabetes medications at clinic visit.

Dr. Robert Ratner, senior scientist at the MedStar Health Research Institute and professor of medicine at Georgetown University School of Medicine in Washington, DC, said programs such as HELP-PD can help primary care practitioners provide needed lifestyle interventions for their patients at risk for diabetes.

American Diabetes Association (ADA) 70th Scientific Sessions. Presented June 29, 2010.