Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial.

BACKGROUND: There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations. OBJECTIVE: Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients' medical and psychosocial needs following hospital discharge. DESIGN: Pragmatic, randomized comparative effectiveness trial. PATIENTS: Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care. INTERVENTIONS: TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source. Routine Care involved assistance scheduling a post-discharge appointment with a primary care provider that often partnered with the hospital where the initial encounter occurred. MAIN MEASURES: The primary outcome was a binary indicator of death or additional hospital encounters within 90 days of initial discharge. Secondary outcomes included any additional hospital encounters, and counts of hospital encounters, over 180 days. KEY RESULTS: Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area. There was no significant difference between arms in the 90-day probability of death or additional hospital encounters (relative risk [RR] 0.89; 0.91; 95% confidence interval [CI] 0.74-1.13). However, TC patients had 37% and 35% lower probability of any inpatient admission over 90 days (RR 0.63; 95% CI 0.43-0.91) and 180 days (RR 0.65; 95% CI 0.47-0.89), respectively. Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90). CONCLUSIONS: Among patients randomized to a patient-centered transitional care intervention, there was no significant reduction in 90-day probability of death or additional hospital encounters. However, there were significant decreases in measures of inpatient admissions over 180 days. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT03066492.

A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes.

OBJECTIVES: We evaluated the weight loss effectiveness of a YMCA model for the Diabetes Prevention Program (DPP) lifestyle intervention. METHODS: Between July 2008 and November 2010, we individually randomized 509 overweight or obese, low-income, nondiabetic adults with elevated blood glucose in Indianapolis, Indiana, to receive standard care plus brief lifestyle counseling or be offered a group-based YMCA adaptation of the DPP (YDPP). Primary outcome was mean weight loss difference at 12 months. In our intention-to-treat analyses, we used longitudinal linear or logistic regression, multiply imputing missing observations. We used instrumental variables regression to estimate weight loss effectiveness among participants completing 9 or more intervention lessons. RESULTS: In the YDPP arm, 161 (62.6%) participants attended ≥ 1 lesson and 103 (40.0%) completed 9 or more lessons. In intention-to-treat analysis, mean 12-month weight loss was 2.3 kilograms (95% confidence interval [CI] = 1.1, 3.4 kg) more for the YDPP arm than for standard care participants. In instrumental variable analyses, persons attending 9 or more lessons had a 5.3-kilogram (95% CI = 2.8, 7.9 kg) greater weight loss than did those with standard care alone. CONCLUSIONS: The YMCA model for DPP delivery achieves meaningful weight loss at 12 months among low-income adults.

Effect of self-efficacy on weight loss: a psychosocial analysis of a community-based adaptation of the diabetes prevention program lifestyle intervention.

Objective. Weight loss is the most effective approach to reducing diabetes risk. It is a research priority to identify factors that may enhance weight loss success, particularly among those at risk for diabetes. This analysis explored the relationships between self-efficacy, weight loss, and dietary fat intake among adults at risk for developing type 2 diabetes. Methods. This pilot, site-randomized trial was designed to compare group-based Diabetes Prevention Program lifestyle intervention delivery by YMCA staff to brief counseling alone (control) in 92 adults at risk for diabetes (BMI ≥ 24 kg/m(2), ≥ 2 diabetes risk factors, and a random capillary blood glucose of 110-199 mg/dl). Self-efficacy was measured using the Weight Efficacy Lifestyle questionnaire. Data were collected at baseline, 6 months, and 12 months. A paired t test was used to determine within-group changes in self-efficacy and weight at 6 and 12 months. Using a fitted model, we estimated how much of an increase in self-efficacy was related to a 5% weight reduction at 6 and 12 months. Results. Self-efficacy was associated with a 5% reduction in baseline weight at 6 and 12 months but was not related to fat intake. Conclusion. These findings suggest that it is important to assess the level of self-efficacy when counseling adults at high risk for diabetes about weight loss. Certain aspects of self-efficacy seem to play a greater role, depending on the stage of weight loss.

Culturally Adapted Lifestyle Intervention for South Asian Adults With Cardiovascular Risk Factors: The SAHELI Randomized Clinical Trial.

Importance: South Asian adults in the US experience excess cardiovascular disease (CVD) compared with other racial and ethnic groups. The effectiveness and reach of guideline-recommended lifestyle interventions have not been evaluated in this population. Objective: To evaluate whether a culturally adapted, group lifestyle intervention will improve CVD risk factors more effectively than written health education materials among US South Asian adults. Design, Setting, and Participants: This single-blind randomized clinical trial was conducted from March 6, 2018, to February 11, 2023 at community sites in the Chicago, Illinois, metropolitan area. South Asian adults aged 18 to 65 years who were overweight or obese, had no history of CVD events, and had at least 1 additional CVD risk factor (hypertension, dyslipidemia, prediabetes, or diabetes) were eligible for inclusion. Intervention: A 16-week, culturally adapted, group-based lifestyle intervention led by community health coaches. Lifestyle modification counseling was delivered in English, Gujarati, Hindi, and Urdu. Participants tracked their diet and physical activity (PA) and received 4 optional group maintenance sessions between months 5 and 11 of follow-up. The intervention was delivered in person prior to the onset of the COVID-19 pandemic and via videoconference starting in March 2020. The control group received written health education materials, delivered monthly. Main Outcomes and Measures: Primary outcomes were the between-group differences in CVD risk factor changes from baseline to 12 months, including weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), and total cholesterol, estimated using multivariate mixed-effects regression models. Secondary outcomes were self-reported diet quality, PA, and self-efficacy, estimated using univariate mixed-effects regression models. Results: Among 549 randomized participants, 318 (57.9%) were women, and mean (SD) participant age was 49.2 (9.5) years. Mean differences in CVD risk factor changes from baseline to 12 months in the intervention vs control group were calculated for weight (mean difference, -0.07 kg; 95% CI, -0.55 to 0.42), SBP (mean difference, 0.47 mm Hg; 95% CI, -1.85 to 2.79), DBP (mean difference, 0.44 mm Hg; 95% CI, -1.06 to 1.95), cholesterol (mean difference, -2.47 mg/dL; 95% CI, -8.51 to 3.57), and HbA1c (mean difference, -0.07%; 95% CI -0.20% to 0.07%). Intervention participation was associated with greater improvements in dietary quality, PA, and self-efficacy than control. Conclusions and Relevance: In the SAHELI randomized clinical trial, a culturally adapted, group lifestyle intervention was not more effective than written health education materials for CVD risk factor reduction among US South Asian adults, but the intervention was associated with small improvements in self-reported health behaviors. Effective CVD prevention interventions for this elevated-risk population require further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT03336255.

A theoretically grounded systematic review of material incentives for weight loss: implications for interventions.

BACKGROUND: Providing material incentives for weight loss is a class of intervention strategies that has received considerable attention; however, the effectiveness of this class of strategies is uncertain. Attending to distinctions among incentive strategies may clarify our understanding of prior work and inform the design of future interventions. PURPOSE: A theoretical framework is proposed that distinguishes between four classes of incentive strategies and is used to organize randomized controlled trials of material incentives for weight loss. METHODS: A systematic literature review was conducted. RESULTS: Findings were mixed with regards to the overall efficacy of material incentives for weight loss. Three of the four proposed incentive categories are represented in the literature. Heterogeneous methods were used across studies rendering comparisons between studies difficult. CONCLUSIONS: Definitive conclusions about the usefulness of material incentives for weight loss could not be drawn. A theoretically grounded approach to designing and testing incentive strategies is encouraged.

A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression.

BACKGROUND: Obesity is associated with clinical depression among women. However, depressed women are often excluded from weight loss trials. PURPOSE: This study examined treatment outcomes among women with comorbid obesity and depression. METHODS: Two hundred three (203) women were randomized to behavioral weight loss (n = 102) or behavioral weight loss combined with cognitive-behavioral depression management (n = 101). RESULTS: Average participant age was 52 years; mean baseline body mass index was 39 kg/m(2). Mean Patient Health Questionnaire and Hopkins Symptom Checklist (SCL-20) scores indicated moderate to severe baseline depression. Weight loss and SCL-20 changes did not differ between groups at 6 or 12 months in intent-to-treat analyses (p = 0.26 and 0.55 for weight, p = 0.70 and 0.25 for depressive symptoms). CONCLUSIONS: Depressed obese women lost weight and demonstrated improved mood in both treatment programs. Future weight loss trials are encouraged to enroll depressed women.

Maintenance-tailored therapy vs. standard behavior therapy for 30-month maintenance of weight loss.

OBJECTIVE: To assess differences in weight regain one year after an 18-month obesity treatment with standard behavior therapy (SBT) or maintenance-tailored therapy for obesity (MTT). METHOD: 213 obese adult volunteers were treated for 18 months using SBT with fixed behavioral prescriptions or MTT that employed varied behavioral prescriptions with treatment breaks. Follow-up analysis focused on weight maintenance after a year of no contact. The trial was conducted at the University of Minnesota between 2005 and 2009. RESULTS: Mean (SD) weight change between 18 and 30 months for participants in the SBT group was +4.1 kg (4.4) compared to +2.8 kg (4.5) in the MTT group. This is a 31% reduction in weight regain in MTT relative to SBT (p=0.078). This trend toward better maintenance in MTT versus SBT was due primarily to superior differential maintenance in MTT participants in the highest tertile of total weight loss at 18 months, i.e. MTT participants in this tertile regained 4 kg less than SBT participants between 18 and 30 months. CONCLUSIONS: The MTT approach with varied content and timing produced more desirable patterns of weight loss maintenance than the traditional SBT approach, especially among individuals who had achieved greater initial weight loss.

Does depression reduce the effectiveness of behavioral weight loss treatment?

Limited evidence suggests that depression is associated with poorer outcomes in behavioral weight loss programs; however, people with major depression are typically excluded from weight loss intervention trials. This study examined the effect of depression on women's participation and weight loss in behavioral treatment. Non-treatment seeking obese women over 40 years of age with major depressive disorder (MDD, n = 65) and without MDD (n = 125) were recruited into a 26-session group intervention. Primary analyses compared participants' mean weight change from baseline to 6 and 12 months; at 6 months, women with MDD lost a mean of 3.8 kg vs 4.3 kg for women without MDD (t = 0.54, p = .59). At 12 months, women with MDD lost 3.0 kg and women without MDD lost 3.6 kg (t = 0.44, p =.66). Women who attended at least 12 treatment sessions lost more weight than women who attended fewer sessions, regardless of depression status (ie, there was no significant interaction between depression and session attendance). Results suggest that depression should not be an exclusion criterion for weight loss intervention programs.

Energy density and weight change in a long-term weight-loss trial.

BACKGROUND: Health risks linked to obesity and the difficulty most have in achieving weight loss underscore the importance of identifying dietary factors that contribute to successful weight loss. METHODS: This study examined the association between change in dietary energy density and weight loss over time. Subjects were 213 men and women with BMI of 30-39 kg/m2 and without chronic illness enrolled in 2004 in a randomized trial evaluating behavioral treatments for long-term weight loss. Subjects completed a 62-item food frequency questionnaire at baseline and at 6, 12, and 18 months. RESULTS: Pearson correlations between BMI and energy density (kcals/g of solid food) at baseline were not significantly different from zero (r = -0.02, p = 0.84). In a longitudinal analysis, change in energy density was strongly related to change in BMI. The estimated beta for change in BMI (kg/m2) of those in the quartile representing greatest decrease in energy density at 18 months compared to those in the quartile with the least was -1.95 (p = 0.006). The association was especially strong in the first six months (estimated beta = -1.43), the period with greatest weight loss (mean change in BMI = -2.50 kg/m2 from 0-6 months vs. 0.23 kg/m2 from 12-18 months) and the greatest contrast with respect to change in energy density. CONCLUSION: Decreased energy density predicted weight loss in this 18 month weight loss study. These findings may have important implications for individual dietary advice and public health policies targeting weight control in the general population.

A comparison of maintenance-tailored therapy (MTT) and standard behavior therapy (SBT) for the treatment of obesity.

OBJECTIVE: To evaluate a maintenance-tailored therapy (MTT) compared to standard behavior therapy (SBT) for treatment of obesity. MAIN OUTCOME MEASURE: change in body weight. METHOD: A non-blinded, randomized trial comparing effectiveness of MTT and SBT in facilitating sustained weight loss over 18 months; 213 adult volunteers> or =18 years participated. SBT had fixed behavioral goals, MTT goals varied over time. Study conducted at the University of Minnesota, School of Public Health, January 2005 through September 2007. RESULTS: Mean (SD) weight losses at 6, 12, and 18 months were 5.7 (5.0) kg, 8.2 (8.6) kg and 8.3 (8.9) kg for MTT and 7.4 (3.9) kg, 10.7 (8.2) kg and 9.3 (8.8) kg for SBT. Total weight loss did not differ by group at 18 months, but the time pattern differed significantly (p<0.001). The SBT group lost more weight in the first 6 months. Both groups lost similar amounts between 6 and 12 months; MTT had stable weight between 12 and 18 months, while SBT experienced significant weight gain. CONCLUSIONS: The MTT approach produced sustained weight loss for an unusually long period of time and not achieved in previous trials of behavioral treatment for weight loss. The MTT approach, therefore, deserves further study.

Training YMCA wellness instructors to deliver an adapted version of the Diabetes Prevention Program lifestyle intervention.

PURPOSE: The purpose of this article is to describe efforts to develop and administer a formal curriculum to train community workers to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention in YMCA settings. The DPP demonstrated that a structured diet and physical activity intervention that achieves and maintains modest weight loss for overweight adults with impaired glucose tolerance can significantly reduce the development of diabetes. Although tens of millions of American adults could benefit from access to the DPP lifestyle intervention, there currently is no available model for nationwide dissemination of this highly beneficial and cost-effective approach to diabetes prevention. A description of 2 ongoing randomized pilot studies provides information about the feasibility and effectiveness of future efforts to apply this new training curriculum on a national scale. CONCLUSIONS: Diabetes educators are challenged to partner with community organizations and other health care workers for extensive distribution of the DPP lifestyle intervention messages.

Reported food choices in older women in relation to body mass index and depressive symptoms.

This paper examines the relationships among reports of depressive symptoms, BMI and frequency of consumption of 30 foods in 4655 middle-aged women. Food was grouped into three categories: high-calorie sweet, high-calorie nonsweet, and low-calorie. Controlling for total energy intake, BMI and depressive symptoms were both inversely associated with a higher frequency of consumption of low-calorie foods. BMI was positively associated with consumption of high-calorie nonsweet foods and negatively related to consumption of high-calorie sweet foods. Depressive symptoms were positively associated with sweet foods consumption and negatively associated with nonsweet foods consumption. These findings suggest that the positive association between BMI and depression in women may be mediated by sweets consumption. This is consistent with the hypothesis that eating sweet foods reduces negative affect.

Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study.

BACKGROUND: The Diabetes Prevention Program (DPP) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes, but there is little information about the feasibility of offering such an intervention in community settings. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA. METHODS: This pilot cluster-randomized trial was designed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone (control) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI>or=24 kg/m2, >or=2 diabetes risk factors, and a random capillary blood glucose of 110-199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight, blood pressures, HbA1c, total cholesterol, and HDL-cholesterol after 6 and 12 months. RESULTS: Among 92 participants, controls were more often women (61% vs 50%) and of nonwhite race (29% vs 7%). After 6 months, body weight decreased by 6.0% (95% CI=4.7, 7.3) in intervention participants and 2.0% (95% CI=0.6, 3.3) in controls (p<0.001; difference between groups). Intervention participants also had greater changes in total cholesterol (-22 mg/dL vs +6 mg/dL controls; p<0.001). These differences were sustained after 12 months, and adjustment for differences in race and gender did not alter these findings. With only two matched YMCA sites, it was not possible to adjust for potential clustering by site. CONCLUSIONS: The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention.

Association between obesity and depression in middle-aged women.

OBJECTIVE: Evaluate the association between obesity and depression among middle-aged women. METHODS: A total of 4641 female health plan enrollees aged 40-65 years completed a structured telephone interview including self-reported height and weight, the Patient Health Questionnaire (PHQ) assessment of depression; a brief measure of rate was 62%. RESULTS: Prevalence of moderate or severe depression increased from 6.5% among those with body mass index (BMI) under 25 to 25.9% among those with BMI over 35. Prevalence of obesity increased from 25.4% among those with no depressive symptoms to 57.8% among those with moderate to severe depression. Independent of obesity, depression was associated with significant reductions in frequency of moderate (4.6 vs. 5.4 times per week) or vigorous (2.8 vs. 3.7 times per week) physical activity. Depression was associated with significantly higher daily caloric intake (1831 vs. 1543) among those with BMI over 30. CONCLUSIONS: Among middle-aged women, depression is strongly and consistently associated with obesity, lower physical activity and (among the obese) higher caloric intake. Public health approaches to reducing the burden of obesity or depression must consider the strong association between these two common conditions.

One-year effects of a group-based lifestyle intervention in adults with type 2 diabetes: A randomized encouragement trial.

AIMS: To estimate the real-world effects of offering a group-based lifestyle intervention (GLI) to adults with diabetes. METHODS: This randomized encouragement trial included adult primary care patients in metropolitan Chicago with type 2 diabetes and body mass index ≥24 kg/m2. Participants were randomized to standard care (brief dietary and lifestyle counseling) or standard care plus being encouraged, but not required, to participate in a free-of-charge GLI offered by the YMCA. The GLI was a group-based adaptation of the Look AHEAD lifestyle intervention. RESULTS: Of 331 participants, 167 were randomized to standard care and 164 to the GLI encouragement arm. About one third of participants were non-Hispanic White (34.4%). In the GLI arm, 75 (45.7%) attended ≥1 GLI visits. In the primary intention-to-treat analysis, the effect of GLI encouragement was 0.95% weight loss at six months (95% confidence interval [CI], 0.13-1.77%; P = 0.02), and 1.20% weight loss at 12 months (95% CI, 0.05-2.36%; P = 0.04). At 12 months, there was a 0.30% (3.3 mmol/mol) reduction in hemoglobin A1c, but this result did not achieve statistical significance (P = 0.054). In instrumental variable analysis estimating effects among the subgroup of participants who attended any GLI visits, the effect of GLI attendance was 2.30% weight loss at six months (95% CI, 0.30-4.30%; P = 0.02), and 2.07% weight loss at 12 months (95% CI, 0.25-3.88%; P = 0.02). We detected no significant blood pressure or cholesterol effects. CONCLUSIONS: Among adults with type 2 diabetes, a group-based lifestyle intervention in a community-based setting achieved modest weight loss at 6 and 12 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01435603.

A pragmatic randomized comparative effectiveness trial of transitional care for a socioeconomically diverse population: Design, rationale and baseline characteristics.

Transitional care programs have been widely used to reduce readmissions and improve the quality and safety of the handoff process between hospital and outpatient providers. Very little is known about effective transitional care interventions among patients who are uninsured or with Medicaid. This paper describes the design and baseline characteristics of a pragmatic randomized comparative effectiveness trial of transitional care. Northwestern Medical Group- Transitional Care (NMG-TC) care model was developed to address the needs of patients with multiple medical problems that required lifestyle changes and were amenable to office-based management. We present the design, evaluation methods and baseline characteristics of NMG-TC trial patients. Baseline demographic characteristics indicate that our patient population is predominantly male, Medicaid insured and non-white. This study will evaluate two methods for implementing an effective transitional care model in a medically complex and socioeconomically diverse population.

Specifying the determinants of the initiation and maintenance of behavior change: an examination of self-efficacy, satisfaction, and smoking cessation.

Using data from smokers (N = 591) who enrolled in an 8-week smoking cessation program and were then followed for 15 months, the authors tested the thesis that self-efficacy guides the decision to initiate smoking cessation but that satisfaction with the outcomes afforded by quitting guides the decision to maintain cessation. Measures of self-efficacy and satisfaction assessed at the end of the program, 2 months, and 9 months were used to predict quit status at 2, 9, and 15 months, respectively. At each point, participants were categorized as either initiators or maintainers on the basis of their pattern of cessation behavior. Across time, self-efficacy predicted future quit status for initiators, whereas satisfaction generally predicted future quit status for maintainers. Implications for models of behavior change and behavioral interventions are discussed.

Design and participant characteristics for a randomized effectiveness trial of an intensive lifestyle intervention to reduce cardiovascular risk in adults with type 2 diabetes: The I-D-HEALTH study.

Intervening in Diabetes with Healthy Eating, Activity and Linkages To Healthcare (I-D-HEALTH) is a community-based randomized trial evaluating the effectiveness of a group-based adaption of the Look AHEAD intensive lifestyle intervention. Most potentially eligible patients were identified through electronic medical record queries or referral to a diabetes resource hub. Trial enrollees had a usual source of primary care, elevated body mass index (BMI) and type 2 diabetes. I-D-HEALTH participants were randomized to either standard care alone or standard care plus free-of-charge access to a group-based lifestyle intervention (GLI) offered by the YMCA. GLI participation was encouraged, but not required, for the latter group. The primary outcome is percent weight change over 6, 12 and 24months. Secondary outcomes include direct intervention costs and direct medical and non-medical expenditures, as well as changes in systolic blood pressure, hemoglobin A1c and cholesterol. Among 331 I-D-HEALTH participants, 167 were randomized to standard care and 164 to GLI. The mean age (±standard deviation) in each group was 57.1years (±12.2) and 57.6years (±10.5), respectively. Mean BMI was 34.9kg/m(2) (±7.3) among standard care participants and 36.2kg/m(2) (±7.8) among GLI participants. In both groups, approximately one third of participants were non-Hispanic Whites. We detected no significant differences between groups in mean systolic blood pressure, hemoglobin A1c or total cholesterol (P >0.05 for all characteristics above). The I-D-HEALTH study enrolled a diverse sample of adults with diabetes and offers a unique opportunity to evaluate the effectiveness of offering a community-based intensive lifestyle intervention.

The effects of outcome expectations and satisfaction on weight loss and maintenance: correlational and experimental analyses--a randomized trial.

This study examines the hypothesis that highly favorable outcome expectations promote weight loss and hinder weight maintenance. To investigate the effects of outcome expectations and satisfaction with treatment outcomes on weight loss, 349 adults were randomly assigned to 1 of 2 weight loss programs that emphasize either (a) an "optimistic" message, focusing exclusively on the positive aspects of weight loss, or (b) a "balanced" message, giving equal time to positive and negative aspects of weight loss. Participants changed their weight loss cognitions in response to the intervention, but there was no significant difference between the intervention treatment groups in short-term or long-term (18-month) weight loss. Independent of treatment message, positive outcome expectations and satisfaction were both associated with weight loss.

Rationale, design, and baseline characteristics of a community-based comparative effectiveness trial to prevent type 2 diabetes in economically disadvantaged adults: the RAPID Study.

Reaching Out and Preventing Increases in Diabetes (RAPID) is a community-based randomized trial evaluating the comparative costs and effectiveness of a group-based adaption of the DPP lifestyle intervention developed and implemented in partnership with the YMCA. RAPID enrolled adult primary care patients, with BMI 24 kg/m(2) or higher and abnormal glucose metabolism (HbA1c 5.7-6.9% or fasting plasma glucose 100-125 mg/dL). 509 participants were enrolled and randomized to one of two groups: standard clinical advice plus free-of-charge access to a group-based adaption of the DPP offered by the Y, versus standard clinical advice alone. Key outcomes for future analysis will include differences in body weight and other cardiovascular risk factors over a 24-month intervention period. At baseline, RAPID participants had a mean (SD) age of 51 ± 12.1 years, weight of 225.1 ± 56.2 lbs, and BMI of 36.9 ± 8.6 kg/m(2). 70.7% were women, 57.2% were African American, 35.4% were non-Hispanic White, and 3.2% were Hispanic. Mean HbA1c was 6.05 ± 0.34%. Additionally, 55.4% of participants had a baseline systolic blood pressure of ≥130 mmHg, 33.1% had a total blood cholesterol exceeding 200mg/dL, and 74% reported a household income of <$25,000. The RAPID Study successfully randomized a large cohort of participants with a wide distribution of age, body weight, and race who are at high risk for developing type 2 diabetes.