Erica L. Rosenberger

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/m2) 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 (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 (CHWs) 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 DCCs and that harnesses the experience of community members (CHWs) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals.

Impact of a Multifaceted Intervention on Cholesterol Management in Primary Care Practices: Guideline Adherence for Heart Health Randomized Trial

BACKGROUND Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor. METHODS We recruited 68 primary care family and internal medicine practices; 66 were randomly allocated to a study arm; 5 practices withdrew, resulting in 29 receiving the Third Adult Treatment Panel (ATP III) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7). The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III-recommended treatment. All practices received copies of each clinical practice guideline, an introductory lecture, 1 performance feedback report, and 4 visits for intervention-specific academic detailing. Data were abstracted at 61 practices from random samples of medical records of patients treated from June 1, 2001, through May 31, 2003 (baseline), and from May 1, 2004, through April 30, 2006 (follow-up). The proportion screened with subsequent appropriate decision making (primary outcome) was calculated. Generalized estimating equations were used to compare results by arm, accounting for clustering of patients within practices. RESULTS We examined 5057 baseline and 3821 follow-up medical records. The screening rate for lipid levels increased from 43.6% to 49.0% (ATP III practices) and from 40.1% to 50.8% (control practices) (net difference, -5.3% [P = .22]). Appropriate management of lipid levels decreased slightly (73.4% to 72.3%) in ATP III practices and more markedly (79.7% to 68.9%) in control practices. The net change in appropriate management favored the intervention (+9.7%; 95% confidence interval [CI], 2.8%-16.6% [P < .01]). Appropriate drug prescription within 4 months decreased in both arms (38.8% to 24.8% in ATP III practices and 45.3% to 24.1% in control practices; net change, +7.2% [P = .37]) Overtreatment declined from 6.6% to 3.9% in ATP III and rose from 4.2% to 6.4% in control practices (net change, -4.9% [P = .01]). CONCLUSIONS A multifactor intervention including personal digital assistant-based decision support may improve primary care physician adherence to the ATP III guidelines. Trial Registration clinicaltrials.gov Identifier: NCT00224848.

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

Appropriateness of Cholesterol Management in Primary Care by Sex and Level of Cardiovascular Risk

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.

Implementing a palm pilot intervention for primary care providers: Lessons learned

A study was undertaken to ascertain the appropriateness of lipid screening and management per the Third Report of the Adult Treatment Panel National Cholesterol Education Program (ATP III) guideline in a sample of North Carolina primary care practices. Demographics, cholesterol values, and comorbid conditions were abstracted from the medical records from 60 community practices participating in a randomized practice-based trial (Guideline Adherence for Heart Health). Eligible patients were aged 21 to 84 years, seen during the baseline period of June 1, 2001, through May 31, 2003, and who were not taking lipid-lowering therapy. Multivariable logistic regression was utilized to assess whether age, sex, race/ethnicity, diabetes, cardiovascular disease, ATP III risk category, or pretreatment low-density lipoprotein (LDL) influenced treatment. Among 5031 eligible patients, 1711 (34.5%) received screening lipid profiles. Screening rates were higher with older age, diabetes, and cardiovascular disease. No large differences were seen by sex. Among patients screened (mean age, 51.6 years; 57.9% female), 76.6% were appropriately managed within 4 months. In adjusted analyses, older age was associated with less appropriate treatment (odds ratio [OR] per 5 years, 0.91; P=.01), and patients with LDL cholesterol <or=130 mg/dL (OR, 18.8; P<.001) and the low-risk group (OR, 27.5; P<.001) were more likely to be managed appropriately compared with patients with LDL >or=190 mg/dL and those at high risk. Among 375 patients eligible for drug treatment, those with LDL levels between 131 and 159 mg/dL were much less likely to be treated (OR, 0.15; P<.001) compared with those with LDL >190 mg/dL, whereas risk category did not influence treatment. The challenge facing implementation of ATP III guidelines is much greater for intermediate- and high-risk patients than for low-risk patients.

P05.11. Time, touch, and compassion: effects on autonomic nervous system and well-being

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

Methods Healthy volunteers were informed that the study was testing the effects of time and touch on the autonomic nervous system. Each subject underwent 5 sequential study periods in one study session: (1) Warm-up; (2) Control with the practitioner while both read neutral material; (3) Rest; (4) Intervention with practitioner meditating on lovingkindness toward the subject; and (5) Rest. Subjects were randomized to receive one of four interventions: a) 10 minutes tactile; b) 20 minutes tactile; c) 10 minutes non-tactile; or d) 20 minutes nontactile. During all NVCC interventions, the practitioner meditated on lovingkindness toward the subject. For tactile interventions, the practitioner touched subjects on arms, legs, and hands; for non-tactile interventions, the practitioner pretended to read. Subjects were monitored continuously for autonomic activity. Subjects completed visual analog scales (VAS) for well-being, including relaxation and peacefulness, at warm-up; postcontrol; immediately post-intervention; and after the post-intervention rest.