HELP PD: Lifestyle intervention as effective as Diabetes Prevention Program

ADA 70th Scientific Sessions

A community-based lifestyle intervention program, modeled after one used in the landmark Diabetes Prevention Program, helped participants lose 7% of their total body weight and reduce blood glucose levels by more than 4 mg/dL after 1 year.

“We believe this approach is able to be readily disseminated to the more than 3,000 diabetes education centers across the United States,”David Goff, PhD, chair of the department of epidemiology and prevention at Wake Forest University School of Medicine, said at a press conference.

The Healthy Living Partnerships to Prevent Diabetes (HELP PD) study evaluated the effects of a lifestyle and weight loss intervention compared with usual care in 301 overweight or obese participants with prediabetes (42% men; 74% white; mean age, 58 years).

Goff presented the 1-year results of the intervention program at the Late-Breaking Clinical Trials Symposium.

Lifestyle intervention vs. usual care

Lifestyle intervention was delivered by registered dietitians and lay community health workers at a diabetes care center in Winston-Salem, N.C. The first 6 months consisted of an intensive phase, with weekly in-group meetings led by the community health workers using DVDs developed from the Diabetes Prevention Program curriculum. After the first 6 months, participants entered a maintenance phase that included monthly group meetings and additional phone or personal contact with the community health workers. The goal of the intensive phase was to achieve at least 7% weight loss through a combination of calorie deficit (500 to 1,000 calories per day) and increased physical activity (at least 180 minutes per week).

The usual care group received two visits with a registered dietitian and a quarterly newsletter with tips for lifestyle changes — “actually more than most would get in routine clinical practice,” Goff said.

According to the results, after 1 year, the lifestyle intervention group also reduced blood glucose levels from 105.5 mg/dL at baseline to 101.3 mg/dL, an average reduction of more than 4 mg/dL, compared with less than 0.3 mg/dL in the usual care group.

Participants assigned to lifestyle intervention also achieved and maintained significantly greater weight loss (average 7.3% of body weight) compared with those assigned to usual care (average 1.3% of body weight). Other positive outcomes associated with the lifestyle intervention included a 5.9-cm decrease in waist circumference vs. 0.8 cm in the usual care group, and improvements in fasting insulin and homeostasis model assessment of insulin resistance.

Goff said there were few adverse events. Although there was not a large enough sample size to monitor the development of diabetes with certainty, he said fewer cases of diabetes have developed in the intervention group — two vs. seven in the usual care group.

Translating care

The HELP PD results are similar to those achieved by participants in the NIH-sponsored Diabetes Prevention Program, in which individuals with prediabetic glucose levels were able to reverse the course of their disease by losing 5% to 7% of total body weight, exercising 150 minutes per week and attending counseling sessions with trained behaviorists.

“We are seeing differences between groups in blood sugar that are comparable to results of both the Diabetes Prevention Program and Finnish Diabetes Study [mean reduction of 4 mg/dL to 5 mg/dL], in which the incidence of new cases of diabetes were reduced by about 60%,” Goff said.

Clinical follow-up at 12 months was about 90% in the intervention group, Goff said. Participants attended about three-quarters of intervention sessions during the first 6 months, and 11% followed up with phone calls.

One limitation of HELP PD is that reimbursement for lifestyle intervention may be a barrier.

When asked at the symposium, Goff said this kind of intervention is not free but is “very affordable.” According to early, rough cost estimates, it is a little more than $400 per year per patient to deliver if the resources and facilities of a diabetes education program are available, he added.

Study participants will be followed for an additional 5 years to evaluate whether individuals maintain weight loss and blood glucose reductions independently or if they need continued group counseling to do so. – by Katie Kalvaitis

We are moving into new area of diabetes prevalence. Evidence such as this really brings to the forefront the translational aspects of what we do in basic science and clinical trials. We need to make it clinically applicable. Things are moving very quickly with health reform; we now have UnitedHealthcare embarking on a program to pay for diabetes education and have the National Diabetes Education Program that is being implemented through the CDC which will also provide lifestyle interventions to try to prevent diabetes in the community. We have an epidemic of obesity, and within that an epidemic of diabetes; if we do not prevent it, it will have fiscal disaster, simply based on diabetes. The evidence is absolutely critical as we move forward to implementing prevention in communities.

– David M. Kendall, MD
Chief Scientific & Medical Officer
American Diabetes Association

For more information:

• Goff D.Late breaking clinical studies. Presented at: American Diabetes Association 70th Scientific Sessions; June 25-29, 2010; Orlando.

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