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.

Healthy Living Partnerships to Prevent Diabetes: recruitment and baseline characteristics.

Healthy Living Partnerships to Prevent Diabetes (HELP PD) is a randomized controlled trial designed to translate the Diabetes Prevention Program (DPP) lifestyle intervention into a community setting using community health workers engaged through an existing Diabetes Care Center (DCC). Overweight and obese (BMI 25-40 kg/m²) individuals with pre-diabetes (fasting blood glucose 95-125 mg/dl) with no medical contraindications to participate in a lifestyle intervention were recruited for participation in this study. Standard recruitment strategies were employed, including mass mailing, direct provider referral, and community events. Participant recruitment and randomization for this trial began in 2007 and was concluded in 2009. 1818 screenings were conducted; of these, 326 (17.9%) qualified and 301 (16.6%) participants were randomized over a 21 month period. 23.8% of potential participants were excluded during the initial telephone screening, primarily for BMI and recent history of CVD. The majority of participants (220, 73.1%) reported mass mailing as their primary source of information about the study. Mass mailing was more effective with participants who identified themselves as white when compared to African-Americans. The cost of recruitment per randomized participant was $816, which includes direct costs and staff effort. 41% of the randomized participants were male and approximately 27% reported a race or ethnicity other than white. In comparison to the DPP study cohort, the HELP PD population is older, more educated and predominately white. These differences, reflecting in part the community in which HELP PD was conducted, may have implications for retention and adherence in the lifestyle intervention group.

Translating diabetes prevention programs: implications for dissemination and policy.

Numerous studies have translated the Diabetes Prevention Program (DPP) for community-based settings, and the results are encouraging. This commentary discusses one community-based DPP translational study, Healthy Living Partnerships to Prevent Diabetes, in detail, as well as the implications of DPP translational studies for public policy.

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.

Implementing a palm pilot intervention for primary care providers: lessons learned.

The Personal Digital Assistance for Guideline Adherence (GLAD Heart) study was designed to test a strategy to improve quality of care through increased adherence to ATPIII cholesterol guidelines. This paper describes the overall study design including the multi-faceted intervention and outcome measures. Sixty-one primary care practices in NC were recruited and randomized to either a personal digital assistant-based cholesterol management intervention or an intervention similar in intensity and frequency of contact but focused on a hypertension clinical practice guideline. Installation and implementation of the technology intervention was challenging. Over the course of the study, there were 74 technical issues requiring assistance for the palm pilot from 23 participating practices. The GLAD Heart project was completed successfully with some impact on cholesterol management. Technology has the potential to improve the quality of care provided in the healthcare setting. However, potentially expensive interventions such as that conducted in GLAD Heart should undergo rigorous testing to assure their efficacy before widespread adoption.

A multifaceted intervention to improve blood pressure control: The Guideline Adherence for Heart Health (GLAD) study.

BACKGROUND: Although high blood pressure is associated with significant morbidity and mortality, the proportion reaching the goal blood pressures as outlined in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, Treatment of High Blood Pressure (JNC 7) is low. We conducted a randomized trial in primary care practices of a multifactorial intervention targeted to improve providers' adherence to hypertension guidelines. METHOD: A total of 61 primary care practices in North Carolina were randomized to receive either a multifactorial intervention (guideline dissemination via a continuing medical education session, academic detailing sessions, audit and feedback on preintervention rates of adherence, and automated blood pressure machines) or an attention control of similar magnitude but targeted at a different guideline. Outcomes were determined through review of patient charts conducted by an independent masked quality assurance organization. RESULTS: We found no difference between the 2 groups in any of the adherence measures including no difference in the percentage of patients at goal (intervention 49.2%, control 50.6%), with undiagnosed hypertension (18.1% vs 13.6%), average systolic (126 vs 125.1 mm Hg), or diastolic blood pressure (73.1 vs 73.4 mm Hg). Similarly, there was no difference in provider adherence to treatment recommendations (use of thiazide-type diuretic as first-line therapy: 32% vs 29.5%; use of 2-drug therapy in stage 2 hypertension: 11.3% vs 10.4%). CONCLUSION: An intensive, multifactorial intervention did not improve adherence to national hypertension guidelines among community-based primary care. Efforts should be focused on other types of interventions to improve rates of control of hypertension.

Control of blood pressure in North Carolina primary care: baseline data from the GLAD Heart Trial.

BACKGROUND: In general, adherence to blood pressure guidelines is low. We assessed whether hypertension recognition and control in North Carolina was consistent with the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) in primary care practices participating in a quality improvement study regarding the implementation of the ATP3 cholesterol management guideline in primary care in North Carolina (GLAD Heart). METHODS: Demographic and clinical data were abstracted from 5,073 charts (patients aged 21-84 years, seen from June 1, 2001 to May 31, 2003) at 60 practices. Sites were non-university based primary care practices from 22 North Carolina counties. A dyslipidemia screening was defined as a lipid profile performed when not on lipid-lowering therapy. Among patients receiving a lipid profile, the proportion with diagnosed, undiagnosed, and controlled hypertension, was calculated according to JNC 7 guidelines. Practice level hypertension control was examined using the median and interquartile range across practices. RESULTS: Among 1,763 patients screened for dyslipidemia, 49.4% had diagnosed hypertension. Only 67 individuals (3.8%) had undiagnosed hypertension. Although 85.8% of hypertensive patients were treated, the median proportions of patients with blood pressure below goal (< 140/90, < 130/80 with diabetes) was 33.3% (21.8%-43.7%), with women more likely to be controlled and individuals treated by a solo provider less likely to be controlled. LIMITATIONS: These data were abstracted from the charts of patients who received a lipid profile; therefore, they are only generalizable to individuals who are screened for hyperlipidemia. CONCLUSIONS: There remains a need to improve hypertension management in North Carolina primary care among patients screened for hyperlipidemia.