The Healthy Living Partnerships to Prevent Diabetes study: 2-year outcomes of a randomized controlled trial.

BACKGROUND: Since the Diabetes Prevention Project (DPP) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58%, several studies have translated the DPP methods to public health-friendly contexts. Although these studies have demonstrated short-term effects, no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up. PURPOSE: To examine the impact of a 24-month, community-based diabetes prevention program on fasting blood glucose, insulin, insulin resistance as well as body weight, waist circumference, and BMI in the second year of follow-up. DESIGN: An RCT comparing a 24-month lifestyle weight-loss program (LWL) to an enhanced usual care condition (UCC) in participants with prediabetes (fasting blood glucose=95-125 mg/dL). Data were collected in 2007-2011; analyses were conducted in 2011-2012. SETTING/PARTICIPANTS: 301 participants with prediabetes were randomized; 261 completed the study. The intervention was held in community-based sites. INTERVENTION: The LWL program was led by community health workers and sought to induce 7% weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity. The UCC received two visits with a registered dietitian and a monthly newsletter. MAIN OUTCOME MEASURES: The main measures were fasting blood glucose, insulin, insulin resistance, body weight, waist circumference, and BMI. RESULTS: Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes (controlling for baseline values) revealed that the LWL participants experienced greater decreases in fasting glucose (-4.35 mg/dL); insulin (-3.01 µU/ml); insulin resistance (-0.97); body weight (-4.19 kg); waist circumference (-3.23 cm); and BMI (-1.40), all p-values <0.01. CONCLUSIONS: A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity.

Cost of a group translation of the Diabetes Prevention Program: Healthy Living Partnerships to Prevent Diabetes.

BACKGROUND: Although numerous studies have translated the Diabetes Prevention Program lifestyle intervention into various settings, no study to date has reported a formal cost analysis. PURPOSE: To describe costs associated with the Healthy Living Partnerships to Prevent Diabetes (HELP PD) trial. DESIGN: HELP PD was a 24-month RCT testing the impact of a lifestyle weight-loss intervention administered through a diabetes education program and delivered by community health workers (CHWs) on blood glucose and body weight among prediabetics. SETTING/PARTICIPANTS: In all, 301 participants with prediabetes were randomized in Forsyth County NC. Data reported in these analyses were collected in 2007-2011 and analyzed in 2011-2012. INTERVENTION: The lifestyle weight-loss group had a 7% weight loss goal achieved and maintained by caloric restriction and increased physical activity. The usual care group received two visits with a registered dietitian and monthly newsletters. MAIN OUTCOME MEASURES: Measures are direct medical costs, direct nonmedical costs, and indirect costs over the 2-year study period. Research costs are excluded. RESULTS: The direct medical cost (in 2010 dollars) to identify one participant was $16.85. Direct medical costs per capita for participants in the usual care group were $142 and $850 for lifestyle weight-loss participants. Per capita direct costs of care outside the study were $7454 for the usual care group and $5177 for the lifestyle weight-loss group. Per capita direct nonmedical costs were $12,881 for the usual care group and $13,836 for the lifestyle weight-loss group. The lifestyle weight-loss group in HELP PD cost $850 in direct medical costs for 2 years, compared to $2631 in direct medical costs for the first 2 years of DPP. CONCLUSIONS: A community-based translation of the DPP can be delivered effectively and with reduced costs.

One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project.

OBJECTIVE: Although the Diabetes Prevention Program (DPP) and the Finnish Diabetes Prevention Study (FDPS) demonstrated that weight loss from lifestyle change reduces type 2 diabetes incidence in patients with prediabetes, the translation into community settings has been difficult. The objective of this study is to report the first-year results of a community-based translation of the DPP lifestyle weight loss (LWL) intervention on fasting glucose, insulin resistance, and adiposity. RESEARCH DESIGN AND METHODS: We randomly assigned 301 overweight and obese volunteers (BMI 25-40 kg/m(2)) with fasting blood glucose values between 95 and 125 mg/dL to a group-based translation of the DPP LWL intervention administered through a diabetes education program (DEP) and delivered by community health workers (CHWs) or to an enhanced usual-care condition. CHWs were volunteers with well-controlled type 2 diabetes. A total of 42.5% of participants were male, mean age was 57.9 years, 26% were of a race/ethnicity other than white, and 80% reported having an education beyond high school. The primary outcome is mean fasting glucose over 12 months of follow-up, adjusting for baseline glucose. RESULTS: Compared with usual-care participants, LWL intervention participants experienced significantly greater decreases in blood glucose (-4.3 vs. -0.4 mg/dL; P<0.001), insulin (-6.5 vs. -2.7 µU/mL; P<0.001), homeostasis model assessment of insulin resistance (-1.9 vs. -0.8; P<0.001), weight (-7.1 vs. -1.4 kg; P<0.001), BMI (-2.1 vs. -0.3 kg/m2; P<0.001), and waist circumference (-5.9 vs. -0.8 cm; P<0.001). CONCLUSIONS: This translation of the DPP intervention conducted in community settings, administered through a DEP, and delivered by CHWs holds great promise for the prevention of diabetes by significantly decreasing glucose, insulin, and adiposity.

Effect of the look AHEAD study intervention on medication use and related cost to treat cardiovascular disease risk factors in individuals with type 2 diabetes.

OBJECTIVE: To examine the effect of a lifestyle intervention to produce weight loss and increased physical fitness on use and cost of medications to treat cardiovascular disease (CVD) risk factors in people with type 2 diabetes. RESEARCH DESIGN AND METHODS: Look AHEAD is a multicenter randomized controlled trial of 5,145 overweight or obese individuals with type 2 diabetes, aged 45-76 years. An intensive lifestyle intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education (DSE) condition. Medications prescribed to treat diabetes, hypertension, and hyperlipidemia were compared at baseline and 1 year. Medication costs were conservatively estimated using prices from a national online pharmacy. RESULTS: Participants randomized to an ILI had significantly greater improvements in CVD risk parameters and reduced medication use and cost compared with those assigned to DSE. At 1 year, average number of medications prescribed to treat CVD risk factors was 3.1 +/- 1.8 for the ILI group and 3.6 +/- 1.8 for the DSE group (P < 0.0001), with estimated total monthly medication costs of $143 and $173, respectively (P < 0.0001). DSE participants meeting optimal care goals at 1 year were taking an average of 3.8 +/- 1.6 medications at an estimated cost of $194/month. ILI participants at optimal care required fewer medications (3.2 +/- 1.7) at lower cost ($154/month) (P < 0.001). CONCLUSIONS: At 1 year, ILI significantly improved CVD risk factors, while at the same time reduced medication use and cost. Continued intervention and follow-up will determine whether these changes are maintained and reduce cardiovascular risk.

Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods.

Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to translate the DPP approach for use in community settings as a cost-effective intervention led by Community Health Workers (CHW's) and administered through a Diabetes Care Center (DCC). Approximately 300 overweight and obese (BMI 25-40 kg/m(2)) individuals with prediabetes (fasting blood glucose 95-124 mg/dl) were randomly assigned to either a lifestyle weight loss intervention (LW) or an enhanced usual care comparison condition (UC). The goal of LW is >or=7% weight loss achieved through increases in physical activity (180 min/wk) and decreases in caloric intake (approximately 1500 kcal/day). The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6 months and monthly thereafter for 18 months. UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter. The primary outcome is change in fasting blood glucose. Secondary outcomes include cardiovascular risk factors, health-related quality of life, and social cognitive variables. Outcomes are masked and are collected every 6 months. The cost-effectiveness of the program will also be assessed. A community-based program that is administered through local DCC's and that harnesses the experience of community members (CHW's) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals.