Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial.

OBJECTIVE: HELP PD was a clinical trial of 301 adults with prediabetes. Participants were randomized to enhanced usual care (EUC) or to a lifestyle weight loss (LWL) intervention led by community health workers that consisted of a 6-month intensive phase (phase 1) and 18 months of maintenance (phase 2). At 24 months, participants were asked to enroll in phase 3 to assess whether continued group maintenance (GM) sessions would maintain improvements realized in phases 1 and 2 compared with self-directed maintenance (SM) or EUC. RESEARCH DESIGN AND METHODS: In phase 3, LWL participants were randomly assigned to GM or SM. EUC participants remained in the EUC arm and, along with participants in SM, received monthly newsletters. All participants received semiannual dietitian sessions. Anthropometrics and biomarkers were assessed every 6 months. Mixed-effects models were used to assess changes in outcomes over time. RESULTS: Eighty-two of the 151 intervention participants (54%) agreed to participate in phase 3; 41 were randomized to GM and 41 to SM. Of the 150 EUC participants, 107 (71%) continued. Ninety percent of clinic visits were completed. Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly (P < 0.001) in the SM group. CONCLUSIONS: Participants in the GM arm maintained weight loss achieved in phases 1 and 2, while those in the SM arm regained weight. Because group session attendance by the participants in the GM arm was low, it is unclear what intervention components led to successful weight maintenance.

The 24-month metabolic benefits of the healthy living partnerships to prevent diabetes: A community-based translational study.

AIMS: Large-scale clinical trials and translational studies have demonstrated that weight loss achieved through diet and physical activity reduced the development of diabetes in overweight individuals with prediabetes. These interventions also reduced the occurrence of metabolic syndrome and risk factors linked to other chronic conditions including obesity-driven cancers and cardiovascular disease. The Healthy Living Partnerships to Prevent Diabetes (HELP PD) was a clinical trial in which participants were randomized to receive a community-based lifestyle intervention translated from the Diabetes Prevention Program (DPP) or an enhanced usual care condition. The objective of this study is to compare the 12 and 24 month prevalence of metabolic syndrome in the two treatment arms of HELP PD. MATERIALS AND METHODS: The intervention involved a group-based, behavioral weight-loss program led by community health workers monitored by personnel from a local diabetes education program. The enhanced usual care condition included dietary counseling and written materials. RESULTS: HELP PD included 301 overweight or obese participants (BMI 25-39.9kg/m2) with elevated fasting glucose levels (95-125mg/dl). At 12 and 24 months of follow-up there were significant improvements in individual components of the metabolic syndrome: fasting blood glucose, waist circumference, HDL, triglycerides and blood pressure and the occurrence of the metabolic syndrome in the intervention group compared to the usual care group. CONCLUSIONS: This study demonstrates that a community diabetes prevention program in participants with prediabetes results in metabolic benefits and a reduction in the occurrence of the metabolic syndrome in the intervention group compared to the enhanced usual care group.

The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results.

A number of research studies have attempted to translate the behavioral lifestyle intervention delivered in the Diabetes Prevention Program (DPP). To compare the active interventions of two trials, Diabetes Prevention Program DPP and Healthy Living Partnerships to Prevent Diabetes (HELP PD), after 1 and 2 years of intervention. DPP included 3234 adults with prediabetes randomized to intensive lifestyle intervention, metformin, troglitazone, or placebo. The lifestyle intervention, professionally delivered to individuals in a clinical setting, focused on diet and increased physical activity. HELP PD, a community-based translation of DPP, included 301 adults randomized to receive intensive lifestyle intervention or enhanced usual care. Mean weight-losses at 1 year (6.9 kg in DPP, 6.4 kg in HELP PD) and 2 years (5.5 kg in DPP, 4.4 kg in HELP PD) were similar across studies. Reductions in glucose were also similar across studies at both time points (5.2 mg/dL in DPP and 4.1 mg/dL in HELP PD at 1 year; 1.8 mg/dL and 1.6 mg/dL at 2 years). HELP PD participants achieved larger reductions in triglycerides at 1 and 2 years (38.4 mg/dL and 34.9 mg/dL, respectively) than DPP participants (24.8 mg/dL and 22.4 mg/dL). High-density lipoprotein decreased in HELP PD participants at year 1 (-0.6 mg/dL) and increased in DPP (1.2 mg/dL) but there were no significant differences in year 2. HELP PD, a community model for diabetes prevention, was similar to DPP in reducing body weight and lowering blood glucose, both important risk factors that should be controlled to reduce risk for developing type 2 diabetes.

Effects of weight regain following intentional weight loss on glucoregulatory function in overweight and obese adults with pre-diabetes.

OBJECTIVE: To assess the extent to which initial, intentional weight loss-associated improvements in glucose tolerance and insulin action are diminished with weight regain. METHODS: 138 overweight and obese (BMI: 32.4±3.9kg/m(2)), adults (59.0±9.7 years), with pre-diabetes were followed through a 6-month weight loss intervention and subsequent 18-month weight maintenance period, or usual care control condition. Longitudinal change in weight (baseline, 6, 24 months) was used to classify individuals into weight pattern categories (Loser/Maintainer (LM), n= 50; Loser/Regainer (LR), n=51; and Weight Stable (WS), n=37). Fasting plasma glucose (FPG), insulin, and insulin resistance (HOMA-IR) were measured at baseline, 6, 12, 18 and 24 months and model adjusted changes, by weight pattern category, were assessed. RESULTS: LMs and LRs lost 8.3±4.7kg (8.7±4.5%) and 9.6±4.7kg (10.2±4.7%) during the first 6 months, respectively. LM continued to lose 1.1±3.4kg over the next 18 months (9.9±6.5% reduction from baseline; p<0.05), while LRs regained 6.5±3.7kg (3.3±5.3% reduction from baseline; p<0.05). Weight change was directly associated with change in all DM risk factors (all p<0.01). Notably, despite an absolute reduction in body weight (from baseline to 24 months) achieved in the LR group, 24-month changes in FPG, insulin, and HOMA-IR did not differ between WS and LR groups. Conversely, LM saw sustained improvements in all measured DM risk factors. CONCLUSIONS: Significant weight loss followed by weight loss maintenance is associated with sustained improvements in FPG, insulin, and HOMA-IR; conversely, even partial weight regain is associated with regression of initial improvements in these risk factors towards baseline values.

Diabetes prevention, weight loss, and social support: program participants' perceived influence on the health behaviors of their social support system.

This study examined participants' perceptions of how their involvement in a well-established weight loss and diabetes prevention program influenced their social support persons (SSPs). Utilizing a mixed-methods approach, participants were surveyed to determine their perceived influence on SSPs. Compared to controls, intervention participants reported that SSPs' lifestyle changes were more positively influenced by their study participation, and their amount of weight loss was related to favorability of perceived changes in SSPs' eating habits. Themes of lifestyle changes, knowledge dissemination, and motivation emerged from responses. Future lifestyle change interventions could potentially capitalize on program participants' influence on their social support networks.

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.

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.

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.

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.