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.