Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER).

INTRODUCTION: The U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER) is conducted to confirm and expand the results of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) in Americans. METHODS: U.S. POINTER was planned as a 2-year randomized controlled trial of two lifestyle interventions in 2000 older adults at risk for dementia due to well-established factors. The primary outcome is a global cognition composite that permits harmonization with FINGER. RESULTS: U.S. POINTER is centrally coordinated and conducted at five clinical sites (ClinicalTrials.gov: NCT03688126). Outcomes assessments are completed at baseline and every 6 months. Both interventions focus on exercise, diet, cognitive/social stimulation, and cardiovascular health, but differ in intensity and accountability. The study partners with a worldwide network of similar trials for harmonization of methods and data sharing. DISCUSSION: U.S. POINTER is testing a potentially sustainable intervention to support brain health and Alzheimer's prevention for Americans. Impact is strengthened by the targeted participant diversity and expanded scientific scope through ancillary studies.

Feasibility and Initial Efficacy Evaluation of a Community-Based Cognitive-Behavioral Lifestyle Intervention to Prevent Excessive Weight Gain During Pregnancy in Latina Women.

About 48 % of US women gain more weight during pregnancy than recommended by the Institute of Medicine (IOM). Excessive gestational weight gain is a major risk factor for obesity in both women and offspring over their lifetimes, and should be avoided. This study was designed to test the feasibility and initial efficacy of a prenatal behavioral intervention in a sample of low-income, predominantly Latina women. The intervention was delivered in groups of 8-10 women in a community recreation center, and structured to reduce the proportion of women who gained weight in excess of IOM guidelines. Recruitment targets were met in 3 months: 135 pregnant women (>10 and <28 weeks) were randomly assigned to receive a 12-week intervention (n = 68) or usual care (n = 67). Retention rate was 81 %. On average, women attended 4 of 12 group sessions, and each session had 4 of the 8-10 assigned participants in attendance. Initial efficacy analyses were based on 87 women. Compared to usual care, fewer normal-weight women in the intervention exceeded IOM recommendations (47.1 % usual care vs. 6.7 % intervention; absolute difference 40.4 %; p = .036). Recommendations for recruitment, retention, and delivery are discussed. A community-based cognitive-behavioral lifestyle intervention during pregnancy was feasible in a hard-to-reach, high-risk population of low-income Latina women, and showed efficacy in preventing excessive gestational weight gain. Due to frequently changing work schedules, strategies are needed to either increase attendance at group sessions (e.g., within a group prenatal care format) or to build core skills necessary for behavior change through other modalities.

Performance of a computer-based assessment of cognitive function measures in two cohorts of seniors.

BACKGROUND: Computer-administered assessment of cognitive function is being increasingly incorporated in clinical trials; however, its performance in these settings has not been systematically evaluated. DESIGN: The Seniors Health and Activity Research Program pilot trial (N = 73) developed a computer-based tool for assessing memory performance and executive functioning. The Lifestyle Interventions and Independence for Elders investigators incorporated this battery in a full-scale multicenter clinical trial (N = 1635). We describe relationships that test scores have with those from interviewer-administered cognitive function tests and risk factors for cognitive deficits and describe performance measures (completeness, intraclass correlations [ICC]). RESULTS: Computer-based assessments of cognitive function had consistent relationships across the pilot and full-scale trial cohorts with interviewer-administered assessments of cognitive function, age, and a measure of physical function. In the Lifestyle Interventions and Independence for Elders cohort, their external validity was further demonstrated by associations with other risk factors for cognitive dysfunction: education, hypertension, diabetes, and physical function. Acceptable levels of data completeness (>83%) were achieved on all computer-based measures; however, rates of missing data were higher among older participants (odds ratio = 1.06 for each additional year; p < 0.001) and those who reported no current computer use (odds ratio = 2.71; p < 0.001). ICCs among clinics were at least as low (ICC < 0.013) as for interviewer measures (ICC < 0.023), reflecting good standardization. All cognitive measures loaded onto the first principal component (global cognitive function), which accounted for 40% of the overall variance. CONCLUSION: Our results support the use of computer-based tools for assessing cognitive function in multicenter clinical trials of older individuals.

Cost and cost-effectiveness analysis of a digital diabetes prevention program: results from the PREDICTS trial.

Although technology-assisted diabetes prevention programs (DPPs) have been shown to improve glycemic control and weight loss, information are limited regarding relevant costs and their cost-effectiveness. To describe a retrospective within-trial cost and cost-effectiveness analysis (CEA) to compare a digital-based DPP (d-DPP) with small group education (SGE), over a 1-year study period. The costs were summarized into direct medical costs, direct nonmedical costs (i.e., times that participants spent engaging with the interventions), and indirect costs (i.e., lost work productivity costs). The CEA was measured by the incremental cost-effectiveness ratio (ICER). Sensitivity analysis was performed using nonparametric bootstrap analysis. Over 1 year, the direct medical costs, direct nonmedical costs, and indirect costs per participant were $4,556, $1,595, and $6,942 in the d-DPP group versus $4,177, $1,350, and $9,204 in the SGE group. The CEA results showed cost savings from d-DPP relative to SGE based on a societal perspective. Using a private payer perspective for d-DPP, ICERs were $4,739 and $114 to obtain an additional unit reduction in HbA1c (%) and weight (kg), and were $19,955 for an additional unit gain of quality-adjusted life years (QALYs) compared to SGE, respectively. From a societal perspective, bootstrapping results indicated that d-DPP has a 39% and a 69% probability, at a willingness-to-pay of $50,000/QALY and $100,000/QALY, respectively, of being cost-effective. The d-DPP was cost-effective and offers the prospect of high scalability and sustainability due to its program features and delivery modes, which can be easily translated to other settings.

Although technology-assisted DPPs have been shown to improve glycemic control and/or weight loss, information is limited on examining relevant costs and the cost-effectiveness of DPPs with the use of remote technologies within a randomized controlled trial design. We evaluated the costs associated with a d-DPP and further examined the cost-effectiveness of the d-DPP with an enhanced usual care condition. The d-DPP was cost-effective in achieving HbA1c reduction and weight loss and offers the prospect of high scalability and sustainability due to its program features and delivery modes, which can be easily translated to other settings.

Effects of a digital diabetes prevention program on cardiovascular risk among individuals with prediabetes.

OBJECTIVE: To examine changes in cardiovascular disease (CVD) risk outcomes of overweight/obese adults with prediabetes. METHODS: Using data from a randomized control trial of digital diabetes prevention program (d-DPP) with 599 participants. We applied the atherosclerotic CVD (ASCVD) risk calculator to predict 10-year CVD risk for d-DPP and small education (comparison) groups. Between-group risk changes at 4 and 12 months were compared using a repeated measures linear mixed-effect model. We examined within-group differences in proportion of participants over time for specific CVD risk factors using generalized estimating equations. RESULTS: We found no differences between baseline 10-year ASCVD risk. Relative to the comparison group, the d-DPP group experienced greater reductions in predicted 10-year ASCVD risk at each follow-up visit and a significant group difference at 4 months (-0.96%; 95% confidence interval: -1.58%, -0.34%) (but not at 12 months). Additionally, we observed that the d-DPP group experienced a decreased proportion of individuals with hyperlipidemia (18% and 16% from baseline to 4 and 12 months), high-risk total cholesterol (8% from baseline to 12 months), and being insufficiently active (26% and 22% from baseline to 4 and 12 months at follow-up time points. CONCLUSIONS: Our findings suggest that a digitally adapted DPP may promote the prevention of cardiometabolic disease among overweight/obese individuals with prediabetes. However, given the lack of maintenance of effect on ASCVD risk at 12 months, there may also be a need for additional interventions to sustain the effect detected at 4 months.

Effects of a Digital Diabetes Prevention Program: An RCT.

INTRODUCTION: In light of the need to expand the reach and access of clinically proven digital Diabetes Prevention Programs (d-DPPs) and the need for rigorous evidence of effectiveness, the purpose of this study was to determine the effectiveness of a digital Diabetes Prevention Program for improving weight, HbA1c, and cardiovascular risk factors among people with prediabetes compared to enhanced standard care plus waitlist control. STUDY DESIGN: This was a single-blind RCT among participants at risk of developing type 2 diabetes and included 12 months of follow-up. SETTING/PARTICIPANTS: A total of 599 volunteer patients with prediabetes were recruited primarily through electronic medical records and primary care practices. INTERVENTION: Participants were randomized to either a d-DPP (n=299) or a single-session small-group diabetes-prevention education class (n=300) focused on action planning for weight loss. The d-DPPs consisted of 52 weekly sessions, lifestyle coaching, virtual peer support, and behavior tracking tools. MAIN OUTCOME MEASURES: The primary outcome was a change in HbA1c from baseline to 12 months using intent-to-treat analyses. On the basis of multiple comparisons of endpoints, 95% CIs are presented and 2-sided p<0.025 was required for statistical significance. Secondary outcomes included body weight and cardiovascular disease risk factors. RESULTS: Among 599 randomized participants (mean age=55.4 years, 61.4% women), 483 (80%) completed the study. The d-DPPs produced significantly greater reductions in HbA1c (0.08%, 95% CI= -0.12, -0.03) and percentage change in body weight (-5.5% vs -2.1%, p<0.001) at 12 months. A greater proportion of the d-DPPs group achieved a clinically significant weight loss ≥5% (43% vs 21%, p<0.001), and more participants shifted from prediabetes to normal HbA1c range (58% vs 48%, p=0.04). Engagement in d-DPPs was significantly related to improved HbA1c and weight loss. CONCLUSIONS: This d-DPPs demonstrated clinical effectiveness and has significant potential for widespread dissemination and impact, particularly considering the growing demand for telemedicine in preventive healthcare services. TRIAL REGISTRATION: This study is registered at www. CLINICALTRIALS: gov (ClinicalTrials.gov Identifier: NCT03312764).

Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: the Seniors Health and Activity Research Program Pilot (SHARP-P) study, a randomized controlled trial.

BACKGROUND: The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. METHODS: SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA) and/or cognitive training intervention (CT) in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. RESULTS: Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004), the interventions produced marked changes in cognitive and physical performance measures (p≤0.05), and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p=0.01). Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome) or 2,000 participants (categorical outcome). CONCLUSIONS: Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00688155.

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.

Psychometric assessment of the Brief Weight-Loss-Related Behavior Self-Efficacy Survey in adults with prediabetes.

Self-efficacy is a commonly examined cognitive determinant of behavior change in weight-loss trials, but there has been little uniformity in its measurement. To address this, a recently developed survey captures self-efficacy as it relates to three behavioral domains of interest to weight-loss interventionists: physical activity (PA), healthful eating, and weight loss. The purpose of this study was to test the psychometric properties of the Brief Weight-Loss-Related Behavior Self-Efficacy Scales in a large sample (n = 599) of adults with prediabetes. Participants completed the self-efficacy survey, as well as measures of PA, dietary intake, weight, and height. The factor structure was scrutinized using exploratory and confirmatory factor analysis, which supported a factor structure with three correlated first-order latent self-efficacy factors, specific to PA, healthful eating, and weight loss. This model is statistically equivalent to a hierarchical model including a second-order factor for overall behavioral weight-management self-efficacy. Measurement equivalence/invariance between relevant demographic groups was also supported by tests for equivalence of covariance matrices. Bivariate correlations between self-efficacy factors and measures of PA, dietary intake, and weight support the concurrent validity of score interpretations. Overall, these psychometric analyses support the validity of these scales' scores as independently reflective of self-efficacy for PA, healthful eating, and weight loss. This instrument is useful in clinical research to identify the cognitive drivers of weight loss and weight loss-inducing behavior. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Using a population health management approach to enroll participants in a diabetes prevention trial: reach outcomes from the PREDICTS randomized clinical trial.

Population health management (PHM) strategies to address diabetes prevention have the potential to engage large numbers of at-risk individuals in a short duration. We examined a PHM approach to recruit participants to a diabetes prevention clinical trial in a metropolitan health system. We examined reach and representativeness and assessed differences from active and passive respondents to recruitment outreach, and participants enrolled through two clinical screening protocols. The PHM approach included an electronic health record (EHR) query, physician review of identified patients, letter invitation, and telephone follow-up. Data describe the reach and representativeness of potential participants at multiple stages during the recruitment process. Subgroup analyses examined proportional reach, participant differences based on passive versus active recruitment response, and clinical screening method used to determine diabetes risk status. The PHM approach identified 10,177 potential participants to receive a physician letter invitation, 60% were contacted by telephone, 2,796 (46%) completed telephone screening, 1,961 were eligible from telephone screen, and 599 were enrolled in 15 months. Accrual was unaffected by shifting clinical screening protocols despite the increase in participant burden. Relative to census data, study participants were more likely to be obese, female, older, and Caucasian. Relative to the patient population, enrolled participants were less likely to be Black and were older. Active respondents were more likely to have a higher income than passive responders. PHM strategies have the potential to reach a large number of participants in a relatively short period, though concerted efforts are needed to increase participant diversity.

The current state of personal training: managers' perspectives.

Fitness managers play an integral role in the day-to-day operation of the facilities in which they work. One of the most critical responsibilities is that of hiring, training, and supervising personal trainers. Research studies have identified a number of qualities and competencies that an effective exercise leader is required to have, but there is little scholarly work addressing managers' attitudes surrounding the performance of personal trainers. Using focus group methodology, managers of personal trainers were recruited to provide viewpoints related to desirable qualities of personal trainers and opinions regarding certification and academic preparation. Responses of the participants were transcribed, coded, and analyzed for themes. Two global themes, Selection Rationale and Negative Characteristics, emerged. Selection Rationale consisted of qualities that influence a manager's decision to hire a particular trainer (e.g., physique, education, social skills). Negative characteristics referred to qualities considered unethical or unprofessional (e.g., sexual comments, misuse of power) and the consequences of those behaviors (e.g., loss of clients, potential for litigation). The results suggest that undergraduate exercise science programs devote additional time toward the development of the affective qualities of future fitness trainers. Managers also recommended licensure for employees.

Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol.

BACKGROUND: Diabetes prevention remains a top public health priority; digital approaches are potential solutions to existing scalability and accessibility challenges. There remains a gap in our understanding of the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings. PURPOSE: To describe the methods and design of a type 1 hybrid effectiveness-implementation trial of a digital diabetes prevention program (DPP) using the iPARIHS and RE-AIM frameworks. METHODS: The trial will contrast the effects of two DPP interventions: (1) small group, in-person class, and (2) a digital DPP consisting of small group support, personalized health coaching, digital tracking tools, and weekly behavior change curriculum. Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the CDC National DPP. Adults at risk for diabetes (BMI ≥25 and 5.7% ≤ HbA1c ≤ 6.4) will be randomly assigned to either the intervention group (n = 241) or the small group (n = 241). Assessment of primary (HbA1c) and secondary (weight loss, costs, cardiovascular risk factors) outcomes will occur at baseline, 4, and 12 months. Additionally, the trial will explore the potential for future adoption, implementation, and sustainability of the digitally-based intervention within a regional healthcare system based on key informant interviews and assessments of organizational administrators and primary care physicians. CONCLUSION: This trial of a digital DPP will allow the research team to determine the relationships between reach, effectiveness, implementation, and costs.

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.

Physical Activity and Performance Impact Long-term Quality of Life in Older Adults at Risk for Major Mobility Disability.

INTRODUCTION: Older adults are a rapidly growing segment of the U.S. POPULATION: Mobility problems that lead to further disability can be addressed through physical activity interventions. Quality of life outcome results are reported from a large trial of physical activity for sedentary older adults at risk for mobility disability. METHODS: Data were from the Lifestyle Interventions and Independence for Elders study. This multisite RCT compared physical activity to health education among 1,635 randomly assigned sedentary older adults at risk for mobility disability in 2010-2011. Measures included demographics; comorbidity; a timed 400-meter walk; the Short Physical Performance Battery; and the Quality of Well-Being Scale (0-1.0 scale). Baseline and long-term follow-up (2.6 years) health-related quality of life data were collected as a secondary outcome. Multivariate linear regression modeling was used to examine covariates of health-related quality of life over time in 2017. RESULTS: The sample had an overall mean Quality of Well-Being score of 0.613. Both groups declined in quality of life over time, but assignment to the physical activity intervention resulted in a slower decline in health-related quality of life scores (p=0.03). Intervention attendance was associated with higher health-related quality of life for both groups. Baseline characteristics including younger age, fewer comorbid conditions, non-white ethnicity, and faster 400-meter walk times were also associated with higher health-related quality of life over time. CONCLUSIONS: Declining mobility measured by physical performance is associated with lower quality of life in sedentary older adults. Physical activity interventions can slow the decline in quality of life, and targeting specific subgroups may enhance the effects of such interventions.

Enhancing quality of life in older adults: a comparison of muscular strength and power training.

BACKGROUND: Although progressive resistance strength training (ST) has been found to improve various measures of physical functioning in older adults, the benefit to quality of life is unclear. Additionally, recent evidence suggests that high velocity power training (PT) may be more beneficial for physical functioning than ST, but it is not known whether this type of training impacts quality of life. The purpose of this study was to compare changes in multiple measures of quality of life resulting from ST vs. PT in older adults. A no exercise group was also included as control comparison condition. METHODS: Forty-five older adults (M age = 74.8 years; SD = 5.7) were randomly assigned to either a) PT, b) ST, or c) control group (no exercise). Measures of self-efficacy (SE), satisfaction with physical function (SPF), and the Satisfaction with Life Scale (SWL) were assessed at baseline and following training. The resistance training conditions met 3 times per week for 12 weeks at an intensity of 70% 1 repetition maximum. RESULTS: A series of ANCOVA's comparing between group differences in change and controlling for baseline values revealed significant group differences in all three measures: SE (F(2,31) = 9.77; p < .001); SPF (F(2,32) = 3.36; p = .047); SWL (F(2,31) = 4.76; p = .016). Follow up analyses indicated that the PT group reported significantly more change in SE, SPF, and SWL than the control group whereas the ST group reported greater change than the control group only in SE. CONCLUSION: These pilot data indicate that high velocity power training may influence multiple levels of quality of life over and above the benefits gained through traditional strength training.

Physical activity in prefrail older adults: confidence and satisfaction related to physical function.

We examined the hypothesis that physical activity will have favorable effects on measures of self-efficacy for a 400-m walk and satisfaction with physical functioning in older adults 70+ years of age who have deficits in mobility. We randomized a total of 412 adults aged 70-89 years at elevated risk for mobility disability to either a physical activity or a successful aging educational control intervention for 12 months. Participants in the physical activity intervention had more favorable changes in both outcomes as a result of treatment than those in the successful aging intervention. Gender, age, and scores on a short physical performance battery did not moderate these effects. Physical activity is an effective means of intervening on self-efficacy and satisfaction with physical function in older adults with impaired lower extremity functioning. This is an important finding in light of the importance of these process variables in behavior change and quality of life.

The current state of personal training: an industry perspective of personal trainers in a small Southeast community.

Although research has identified a number of qualities and competencies necessary to be an effective exercise leader, the fitness industry itself is largely unregulated and lacks a unified governing body. As such, a plethora of personal trainer certifications exists with varying degrees of validity that fail to ensure qualified trainers and, therefore, protect the consumer. It is argued that the potential consequences of this lack of regulation are poor societal exercise adherence, potential injury to the client, and poor public perception of personal trainers. Additionally, it is not known whether personal trainers are meeting the needs of their clients or what criteria are used in the hiring of personal trainers. Thus, the purpose of this investigation was to examine the current state of personal training in a midsized Southeast city by using focus group methodology. Local personal trainers were recruited for the focus groups (n = 11), and the results from which were transcribed, coded, and analyzed for themes using inductive reasoning by the authors. Qualities and characteristics that identified by participants clustered around 4 main themes. Client selection rationale consisted of qualities that influenced a client's decision to hire a particular trainer (e.g., physique, gender, race). Client loyalty referred to the particular qualities involved in maintaining clients (e.g., motivation skills, empathy, social skills). Credentials referred to formal training (e.g., college education, certifications). Negative characteristics referred to qualities considered unethical or unprofessional (e.g., sexual comments, misuse of power) as well as the consequences of those behaviors (e.g., loss of clients, potential for litigation). These results are discussed regarding the implications concerning college programs, certification organizations, increasing public awareness of expectations of qualified trainers, and a move towards state licensure.

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.