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Participant engagement in structured lifestyle change programs (LCPs) is essential for adopting behaviors that promote weight loss; however, the challenges to, and facilitators that promote, engagement with such programs are not well understood. We conducted a mixed-methods study among real-world LCP participants to assess factors associated with program engagement and to examine the reasons for withdrawal. Using electronic health records (EHR), we identified LCP eligible participants between 2010 and 2017. Multivariable logistic regression was used to assess associations between program engagement and baseline characteristics. Semi-structured interviews with LCP participants were conducted and thematically analyzed to examine reasons for withdrawal. A total of 1,813 LCP participants were included. The median number of sessions attended was 10 of 21–25 sessions. Highest LCP engagement was associated with factors potentially related to self-efficacy/motivation, such as older age, higher baseline weight, prior healthcare utilization and an absence of a history of smoking or depression. Engagement was also negatively associated with being Non-Hispanic Black versus White. The qualitative analysis of the interviews revealed four general themes pertaining to participants’ withdrawal: competing priorities, perceived program effectiveness, characteristics of the program, and facilitator-related factors. Taken together, results from this mixed-methods study suggest that motivation and self-efficacy are important for program engagement; future LCP enhancements should incorporate flexible formats that may help participants manage competing priorities and maximize personal and cultural relevance for all racial/ethnic groups, especially those who have not benefitted fully. Furthermore, participants should be encouraged to set realistic goals to manage expectations.

Latino men have been drastically under-represented in research to identify effective behavioral weight-loss interventions. This trial compared 2 interventions for weight loss: (1) a culturally adapted intervention (HOMBRE) and (2) a minimal-intensity intervention.Randomized controlled trial.Latino men with a BMI ≥27 kg/mHOMBRE provided men a choice among 3 options: coach-facilitated group sessions using online video conferencing, coach-facilitated group sessions in person, and prerecorded videos of group sessions available online.The primary outcome was the proportion of participants sustaining clinically significant (≥5% of baseline) weight loss at 18 months. Secondary outcomes included weight loss trajectory over time, 3% and 10% weight loss, cardiometabolic risk factors, health behaviors, and psychosocial well-being at baseline and 18 months. Data were analyzed from October 6, 2020 to January 15, 2022.Participants were predominantly middle aged (47.0 [SD=11.9] years), were married (74.3%), were with at least some college experience (79.7%), and had middle to upper incomes (72.4% with annual family incomes$75,000). Their average BMI was 33.1 kg/mAmong Latino men with overweight and obesity, HOMBRE was not more effective for clinically significant weight loss than a minimal-intensity intervention at 18 months.

Psychotherapy is a standard depression treatment; however, determining a patient's prognosis with therapy relies on clinical judgment that is subject to trial-and-error and provider variability.To develop machine learning (ML) algorithms to predict depression remission for patients undergoing 6 months of problem-solving therapy (PST).Using data from the treatment arm of 2 randomized trials, ML models were trained and validated on ENGAGE-2 (ClinicalTrials.gov, #NCT03841682) and tested on RAINBOW (ClinicalTrials.gov, #NCT02246413) for predictions at baseline and at 2-months. Primary outcome was depression remission using the Depression Symptom Checklist (SCL-20) score 0.5 at 6 months. Predictor variables included baseline characteristics (sociodemographic, behavioral, clinical, psychosocial) and intervention engagement through 2-months.Of the 26 candidate variables, 8 for baseline and 11 for 2-months were predictive of depression remission, and used to train the models. The best-performing model predicted remission with an accuracy significantly greater than chance in internal validation using the ENGAGE-2 cohort, at baseline [72.6% (SD = 3.6%), p 0.0001] and at 2-months [72.3% (5.1%), p 0.0001], and in external validation with the RAINBOW cohort at baseline [58.3% (0%), p 0.0001] and at 2-months [62.3% (0%), p 0.0001]. Model-agnostic explanations highlighted key predictors of depression remission at the cohort and patient levels, including female sex, lower self-reported sleep disturbance, lower sleep-related impairment, and lower negative problem orientation.ML models using clinical and patient-reported data can predict depression remission for patients undergoing PST, affording opportunities for prospective identification of likely responders, and for developing personalized early treatment optimization along the patient care trajectory.

To examine the association between COVID-19 impact and clinical outcomes of an integrated collaborative care intervention for adults with obesity and comorbid depression.Latent class analysis identified clusters of self-reported COVID-19 impact. Cluster characteristics were examined using Fishers' least significant difference method and canonical discriminant analysis. Intervention vs. usual care effects on primary (body mass index [BMI], depressive symptoms) and secondary (anxiety symptoms and other psychosocial) outcomes stratified by cluster were examined using linear mixed models.Three clusters were identified: mental health and sleep impact (cluster 1, n = 37), economic impact (cluster 2, n = 18), and less overall impact (cluster 3, n = 20). Clusters differed in age, income, diet, and baseline coping skills. The intervention led to improvements across several health outcomes compared with usual care, with medium to large effects on functional impairments (standardized mean difference, -0.7 [95% CI: -1.3, -0.1]) in cluster 1, depressive symptoms (-1.1 [95% CI: -2.0, -0.1]) and obesity-related problems (-1.6 [95% CI: -2.8, -0.4]) in cluster 2, and anxiety (-1.1 [95% CI: -1.9, -0.3]) in cluster 3.People with obesity and comorbid depression may have varied intervention responses based on COVID-19 impact. Interventions tailored to specific COVID-19 impact clusters may restore post-pandemic health.

Introduction Diabetes and obesity pose a significant burden for the U.S. military beneficiary population, creating a great need to provide evidence-based diabetes and obesity prevention services for military personnel, retirees, and their dependents. Despite increasing dissemination of the Diabetes Prevention Program (DPP) lifestyle intervention nationwide, formal evaluation of implementation of this highly successful program is limited in the military setting. The purpose of this study is to prospectively evaluate delivery of a direct adaptation of a 1-year DPP lifestyle intervention at a U.S. Air Force medical facility, Wright-Patterson Medical Center (WPMC), to determine the feasibility of delivery of the program in a group of at-risk active duty military, retirees, and family members, as well as assess effectiveness in improving weight and other risk factors for type 2 diabetes. Materials and Methods A pre/post study design was utilized to evaluate feasibility and effectiveness of the DPP Group Lifestyle Balance (GLB), an up-to-date, 22-session direct adaptation of the DPP curriculum, at WPMC. Participants chose to complete the 1-year program either in coach-led face-to-face groups or via DVD with weekly telephonic coach contact. The study was approved by the University of Pittsburgh and WPMC Institutional Review Boards. Results A total of 99 individuals enrolled in the study, with 83 (84%) and 77 (78%) completing 6- and 12-month follow-up assessments, respectively. The mean age of participants at baseline was 57 (range 20-85 years), with 63% being female. The group was comprised of individuals who were non-Hispanic White (73.7%), non-Hispanic Black (18.2%), and other race or Hispanic ethnicity (8.1%). Within this group, there were 10 active duty military, 37 retirees, and 52 family members. The DPP-GLB program was shown to be feasible to implement in this military healthcare setting as demonstrated by the high engagement over the course of the year-long program. Significant improvements were shown in the two main behavioral goals: mean weight (−12.8 lbs, −6.3%, P Conclusions These results demonstrate that the DPP-GLB program delivered via face-to-face groups or DVD was feasible and effective in improving weight, PA levels, and diabetes and cardiovascular risk factors in this group of active and retired military personnel and their family members. The program was well received by the program participants as well as the WPMC team. These findings offer a model for provision of the DPP-GLB program throughout the Military Health System.

This analysis examined whether a community-based intervention produced measurable improvements in dietary habits. MOVE UP combined translational, evidence-based weight management and healthy aging interventions using a non-randomized design. This 13-month intervention included 32 group sessions, explicit calorie and physical activity goals, self-monitoring, and nutrition education. Participants were ( N = 297) older adults (mean = 68.0 years) with overweight and obesity. Diet was measured using Rate Your Plate (RYP)-Heart. Changes in scores from baseline to 5, 9, and 13 months were assessed using mixed models. MOVE UP successfully shifted eating patterns from baseline (mean = 50.9) to 5 months (mean = 55.1) ( p < .0001) adjusted for age, sex, and race. Improvements persisted through 9 (mean = 54.7) and 13 months (mean = 55.0) ( p < .0001). Although participants were not prescribed a specific diet, RYP-Heart indicated positive dietary shifts. Community-implemented behavioral weight loss interventions may assess the modifiability of dietary habits with a simple, easy-to-administer tool.

BACKGROUND: Depression hinders obesity treatment; elucidating mechanisms may enable treatment enhancements. OBJECTIVES: The aim was to investigate whether changes in neural targets in the negative affect circuit following psychotherapy mediate subsequent changes in weight and behaviors. METHODS: Adults (n = 108) with obesity and depression were randomly assigned to usual care or an intervention that delivered problem-solving therapy (PST) for depression over 2 mo. fMRI for brain imaging was performed at baseline and 2 mo. BMI, physical activity, and diet were measured at baseline and 12 mo. Mediation analysis assessed between-group differences in neural target changes using t test and correlations between neural target changes and outcome changes (simple and interaction effect) using ordinary least-squares regression. RESULTS: Compared with usual care, PST led to reductions in left amygdala activation (−0.75; 95% CI: −1.49, −0.01) and global scores of the negative affect circuit (−0.43; −0.81, −0.06), engaged by threat stimuli. Increases in amygdala activation and global circuit scores at 2 mo correlated with decreases in physical activity outcomes at 12 mo in the usual-care group; these relations were altered by PST. In relation to change in leisure-time physical activity, standardized β-coefficients were −0.67 in usual care and −0.01 in the intervention (between-group difference: 0.66; 0.02, 1.30) for change in left amygdala activation and −2.02 in usual care and −0.11 in the intervention (difference: 1.92; 0.64, 3.20) for change in global circuit scores. In relation to change in total energy expenditure, standardized β-coefficients were −0.65 in usual care and 0.08 in the intervention (difference: 0.73; 0.29, 1.16) for change in left amygdala activation and −1.65 in usual care and 0.08 in the intervention (difference: 1.74; 0.85, 2.63) for change in global circuit scores. Results were null for BMI and diet. CONCLUSIONS: Short-term changes in the negative affect circuit engaged by threat stimuli following PST for depression mediated longer-term changes in physical activity. This trial was registered at www.clinicaltrials.gov as NCT02246413 (https://clinicaltrials.gov/ct2/show/NCT02246413).

BackgroundThe 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) 3rd expert report highlights up-to-date Cancer Prevention Recommendations that may reduce burdens of many chronic diseases, including diabetes. This study examined if following a lifestyle that aligns with the recommendations – assessed via the 2018 WCRF/AICR Score – was associated with lower risk of type 2 diabetes in high-risk adults participating in the Diabetes Prevention Program Outcomes Study (DPPOS).MethodsThe Diabetes Prevention Program (DPP) randomized adults at high risk for diabetes to receive a lifestyle intervention (ILS), metformin (MET) or a placebo (PLB) (mean: 3.2 years), with additional follow-up in DPPOS for 11 years (mean: 15 years total). 2018 WCRF/AICR Scores included seven components: body weight, physical activity, plant-based foods, fast foods, red and processed meat, sugar-sweetened beverages, and alcohol; the optional breastfeeding component was excluded. Scores ranged 0-7 points (with greater scores indicating greater alignment with the recommendations) and were estimated at years 0, 1, 5, 6, 9, and 15 (N=3,147). Fasting glucose and HbA1c were measured every six months and oral glucose tolerance tests were performed annually. Adjusted Cox proportional hazard ratios (HRs) and 95% confidence intervals (CIs) were used to examine the association of both Score changes from years 0-1 and time-dependent Score changes on diabetes risk through DPP and year 15.ResultsScores improved within all groups over 15 years (ppConclusionsScore improvements were associated with long-term, lower diabetes risk among high-risk adults randomized to ILS and PLB, but not MET. Future research should explore impact of the Score on cancer risk.Trial registrationDiabetes Prevention Program:NCT00004992; Diabetes Prevention Program Outcomes Study:NCT00038727

Background Older informal caregivers are prone to sedentary behavior and obesity. With great caregiving burdens and frequent physical and mental distress, older informal caregivers may have low adherence and poor results in behavioral intervention for weight management. This study examined whether overweight or obese older informal caregivers could benefit from a behavioral weight management program as much as non-caregivers. Methods The Mobility and Vitality Lifestyle Program (MOVE UP) was a pre-post, community-based, 13-month lifestyle intervention study to help older adults improve physical function performance and lose weight. We identified a subset of informal caregivers (n = 29) and non-caregivers (n = 65) from the MOVE UP participants retrospectively. Changes in lower extremity function, weight, depressive symptoms, and self-efficacy from baseline were compared between caregivers and non-caregivers using paired t-tests and ANCOVA. Results Older informal caregivers had significantly lower session attendance rates than non-caregivers (67.7% vs 76.8%, P Ps Conclusion This study provides evidence that older informal caregivers can benefit from behavioral weight management interventions despite the challenge caregiving poses for effective self-care. Future behavioral intervention studies for older informal caregivers should adopt self-monitoring tools and extend the on-site delivery to home-based settings for higher adherence and greater flexibility. Trial registration Registered at clinicaltrials.gov (NCT02657239).

Background and Objectives The high prevalence of overweight or obesity in older adults is a public health concern because obesity affects health, including the risk of mobility disability. Research Design and Methods The Mobility and Vitality Lifestyle Program, delivered by community health workers (CHWs), enrolled 303 community-dwelling adults to assess the impact of a 32-session behavioral weight management intervention. Participants completed the program at 26 sites led by 22 CHWs. Participation was limited to people aged 60–75 who had a body mass index (BMI) of 27–45 kg/m2. The primary outcome was the performance on the Short Physical Performance Battery (SPPB) over 12 months. Results Participants were aged 67.7 (SD 4.1) and mostly female (87%); 22.7% were racial minorities. The mean (SD) BMI at baseline was 34.7 (4.7). Participants attended a median of 24 of 32 sessions; 240 (80.3%) completed the 9- or 13-month outcome assessment. Median weight loss in the sample was 5% of baseline body weight. SPPB total scores improved by +0.31 units (p < .006), gait speed by +0.04 m/s (p < .0001), and time to complete chair stands by −0.95 s (p < .0001). Weight loss of at least 5% was associated with a gain of +0.73 in SPPB scores. Increases in activity (by self-report or device) were not independently associated with SPPB outcomes but did reduce the effect of weight loss. Discussion and Implications Promoting weight management in a community group setting may be an effective strategy for reducing the risk of disability in older adults.

Background. The Mobility and Vitality Lifestyle Program (MOVE UP) is a behavioral weight-management intervention for improving mobility among community-dwelling older adults. We examined program factors that affect implementation outcomes and participant-level health outcomes. Methods. The MOVE UP program was implemented in the greater Pittsburgh area from January 2015 to June 2019 to improve lower extremity performance in community-dwelling older adults who were overweight or obese. Thirty-two sessions were delivered over 13 months. All sessions were designed to be 1-hour in length, on-site, group-based, and led by trained and supported community health workers (CHWs). Participants completed weekly Lifestyle Logs for self-monitoring of body weight, diet, and physical activity. We evaluated the MOVE UP program using the RE-AIM framework, and collected quantitative data at baseline, 5-, 9-, and 13-months. Multilevel linear regression models assessed the impacts of program factors (site, CHW, and participant characteristics) on implementation outcomes and participant-level health outcomes. Results. Twenty-two CHWs delivered MOVE UP program to 303 participants in 26 cohorts. Participants were similar to the target source population in weight but differed in some demographic characteristics. The program was effective for weight loss and lower extremity function in both intervention and maintenance periods (Ps < .01), with an independent effect for Lifestyle Logs submission but not session attendance. Discussion. CHWs were able to deliver a multi-component weight loss intervention effectively in community settings. CHW and site characteristics had independent impacts on participants’ adherence. Lifestyle Log submission may be a more potent measure of adherence in weight loss interventions than attendance.

Background Frailty is a geriatric syndrome of decreased physiologic reserve and resistance to stressors that results in increased vulnerability to adverse health outcomes with aging. Diabetes and hyperglycemia are established risk factors for frailty. We sought to examine whether the odds of frailty among individuals at high risk of diabetes randomized to treatment with intensive lifestyle (ILS), metformin, or placebo differed after long-term follow-up. Method The sample comprised participants in the Diabetes Prevention Program (DPP) clinical trial, who continued follow-up in the DPP Outcomes Study (DPPOS) and completed frailty assessments in DPPOS Years 8 (n = 2385) and 10 (n = 2289), approximately 12 and 14 years after DPP randomization. Frailty was classified using Fried Frailty Phenotype criteria. GEE models adjusting for visit year with repeated measures pooled for Years 8 and 10 were used to estimate pairwise odds ratios (ORs) between ILS, metformin, and placebo for the outcomes of frail and prefrail versus nonfrail. Results Frailty prevalence by treatment group was ILS = 3.0%, metformin = 5.4%, placebo = 5.7% at Year 8, and ILS = 3.6%, metformin = 5.3%, placebo = 5.4% at Year 10. Odds ratios (95% CI) estimated with GEE models were ILS versus placebo, 0.62 (0.42–0.93), p = .022; metformin versus placebo, 0.99 (0.69–1.42), p = .976; and ILS versus metformin, 0.63 (0.42–0.94), p = .022. Odds of being frail versus nonfrail were 37% lower for ILS compared to metformin and placebo. Conclusions Early ILS intervention, at an average age of about 50 years, in persons at high risk of diabetes may reduce frailty prevalence in later life. Metformin may be ineffective in reducing frailty prevalence. Clinical Trials Registration Numbers NCT00004992 (DPP) and NCT00038727 (DPPOS).

Background We evaluated whether diet quality is a predictor of weight loss and reduced diabetes risk, independent of caloric intake in the Diabetes Prevention Program (DPP) cohort, a randomized clinical trial of adults at risk for diabetes. Methods This secondary analysis included 2914 participants with available data (964 intensive lifestyle (ILS), 977 metformin, 973 placebo). Dietary intake was assessed using a 117-item food frequency questionnaire. Diet quality was quantified using the Alternative Healthy Eating Index 2010 (AHEI). AHEI ranges from 0 to 110, with higher scores corresponding to higher quality diets. ILS participants had greater improvement (p Results An increase in AHEI score was associated with weight loss in ILS [β per 10-point increase (SE) -1.2 kg (0.3, p p p = 0.01)]. However, AHEI change was not associated with incident diabetes in any group before or after adjustment for weight change. Conclusions Controlling for weight, diet quality was not associated with diabetes incidence but helps achieve weight loss, an important factor in diabetes prevention.

OBJECTIVE Across the Diabetes Prevention Program (DPP) follow-up, cumulative diabetes incidence remained lower in the lifestyle compared with the placebo and metformin randomized groups and could not be explained by weight. Collection of self-reported physical activity (PA) (yearly) with cross-sectional objective PA (in follow-up) allowed for examination of PA and its long-term impact on diabetes prevention. RESEARCH DESIGN AND METHODS Yearly self-reported PA and diabetes assessment and oral glucose tolerance test results (fasting glucose semiannually) were collected for 3,232 participants with one accelerometry assessment 11–13 years after randomization (n = 1,793). Mixed models determined PA differences across treatment groups. The association between PA and diabetes incidence was examined using Cox proportional hazards models. RESULTS There was a 6% decrease (Cox proportional hazard ratio 0.94 [95% CI 0.92, 0.96]; P < 0.001) in diabetes incidence per 6 MET-h/week increase in time-dependent PA for the entire cohort over an average of 12 years (controlled for age, sex, baseline PA, and weight). The effect of PA was greater (12% decrease) among participants less active at baseline ( CONCLUSIONS PA was inversely related to incident diabetes in the entire cohort across the study, with cross-sectional accelerometry results supporting these findings. This highlights the importance of PA within lifestyle intervention efforts designed to prevent diabetes and urges health care providers to consider both PA and weight when counseling high-risk patients.

Objective: Excessive gestational weight gain (eGWG) is associated with adverse long-term maternal outcomes. Most lifestyle interventions that incorporate physical activity have been ineffective at reducing eGWG. The purpose of this study is to determine if sleep modified the relationships between physical activity change from the 2nd to 3rd trimester and the odds of excessive gestational weight gain (eGWG). Methods: This was a secondary data analysis of a prospective cohort study of pregnant birthing people with overweight or obesity (n = 105). We estimated physical activity energy expenditure (PAEE) in the 2nd and 3rd trimesters of pregnancy and sleep characteristics (i.e., sleep quality, daytime dysfunction, sleep efficiency, sleep duration) in the 2nd trimester of pregnancy with validated measures. We used regression models with sleep and PAEE change (increase/stable vs. decrease) interaction terms to examine the impact of sleep on PAEE change and eGWG. Results: Mean GWG was 37.02±16.76 lbs. and 80% of participants experienced eGWG. 18% of participants increased their PAEE from the 2nd to the 3rd trimester. Increasing (vs. decreasing) PAEE was associated with lower log-odds of eGWG only among participants that slept at least 8 hours/night (p=0.06), had at least 85% sleep efficiency (p=0.03), or reported less daytime dysfunction (p=0.08). Sleep quality did not moderate the association between PAEE change and eGWG. Conclusions: Weight management interventions in pregnancy should consider screening for and addressing poor sleep in the second trimester.

Excessive gestational weight gain (eGWG) is associated with adverse long-term maternal outcomes. Most lifestyle interventions that incorporate physical activity have been ineffective at reducing eGWG. The purpose of this study was to determine if sleep modified the relationships between physical activity change from the 2nd to 3rd trimester and the odds of excessive gestational weight gain (eGWG).This was a secondary data analysis of a prospective cohort study of pregnant birthing people with overweight or obesity (n = 105). We estimated physical activity energy expenditure (PAEE) in the 2nd and 3rd trimesters of pregnancy and sleep characteristics (i.e., sleep quality, daytime dysfunction, sleep efficiency, sleep duration) in the 2nd trimester of pregnancy with validated measures. We used regression models with sleep and PAEE change (increase/stable vs. decrease) interaction terms to examine the impact of sleep on PAEE change and eGWG.Mean GWG was 37.02 ± 16.76 lbs. and 80% of participants experienced eGWG. Eighteen percent of participants increased their PAEE from the 2nd to the 3rd trimester. Increasing (vs. decreasing) PAEE was associated with lower log-odds of eGWG only among participants that slept at least 8 h/night (p = 0.06), had at least 85% sleep efficiency (p = 0.03), or reported less daytime dysfunction (p = 0.08). Sleep quality did not moderate the association between PAEE change and eGWG.Weight management interventions in pregnancy should consider screening for and addressing poor sleep in the second trimester.

Background Group lifestyle sessions with phone maintenance could improve weight, health, and function in vulnerable older adults. Methods Community-dwelling adults (N = 322) with body mass index (BMI, kg/m2) ≥27 and additional risk factors received 12 one-hour in-person behavioral weight management group sessions then were randomized to 8 half-hour telephone sessions (n = 162) or newsletter control (n = 160) from 4 to 12 months with no treatment contact thereafter. Primary outcome was 0- to 12-month weight change. Cardiometabolic, short physical performance battery (SPPB), and self-reported activity changes were assessed at 12 and 24 months. Results At baseline, the mean (SD) age was 71.2 (4.3) and BMI was 33.8 (5.1). Participants were 77% women, 13% Black, 85% retired, averaging 4 medical conditions, and taking blood pressure (67.4%) and lipid-lowering (51.6%) medications. At 12 months, a greater proportion of the phone group (66.0%) achieved ≥5% weight loss compared with newsletter control (53.2%; p = .02). Mean (95% CI) weight loss was greater for phone (−6.6 kg [−7.5, −5.8]) than newsletter (−5.1 kg [−7.2, −3.0]); p = .01. Modest lipid, glucose, and blood pressure improvements were found, but did not differ significantly between groups. Small SPPB and activity improvements were maintained at 12 and 24 months in both groups. Conclusions Brief phone contacts compared to newsletters enhanced weight loss maintenance among older high-risk adults at 1 year, but not cardiometabolic outcomes. Modest functional improvements were observed in both. Lower-intensity maintenance contacts (phone or newsletter) for weight, health, and physical function in older adults warrant further study. Clinical Trials Registration Number NCT03192475

The objective of this study was to present lessons learned about engagement, delivery modality and pandemic impact while delivering a collaborative care intervention with a socioeconomically, racially and ethnically diverse sample. Participants completed a post-intervention survey (n = 41) on experiences and preferred intervention delivery modality, coronavirus 2019 (COVID-19) Impact Survey (n = 50) and provided open-ended feedback about the intervention (n = 27). Intervention process data included attendance, modality, and withdrawals. Data were analyzed using descriptive statistics and inductive content analyses. Of 71 intervention participants, 6 (8%) withdrew before session 1. Completers adhered to intervention timeline better than withdrawals. Participants liked the in-person interaction, efficient coach support, accountability of in-person and Zoom vs. phone sessions and the flexibility and convenience of phone and Zoom vs. in-person sessions. A majority of participants reported experiencing pandemic impacts such as heightened emotional distress, decreased activity engagement, poorer eating behaviors and being unable to meet basic needs. Participants deviating from intervention timelines may be re-engaged by targeted outreach attempts. Videoconference has the potential for providing as-needed coaching. Future interventions may be optimized to account for and address areas impacted by the pandemic. Findings revealed specific strategies that can be implemented in future interventions to improve emotional and physical health among diverse populations.

Purpose The purpose of this study was to examine how maintenance session attendance and 6-month weight loss (WL) goal achievement impacted 12-month 5% WL success in older adults participating in a community-based Diabetes Prevention Program (DPP) lifestyle intervention. Methods Data were combined from 2 community trials that delivered the 12-month DPP-based Group Lifestyle Balance (GLB) to overweight/obese adults (mean age = 62 years, 76% women) with prediabetes and/or metabolic syndrome. Included participants (n = 238) attended ≥4 core sessions (months 0-6) and had complete data on maintenance attendance (≥4 of 6 sessions during months 7-12) and 6- and 12-month WL (5% WL goal, yes/no). Multivariate logistic regression was used to estimate the odds of 12-month 5% WL associated with maintenance attendance and 6-month WL. Associations between age (Medicare-eligible ≥65 vs Results Both attending ≥4 maintenance sessions and meeting the 6-month 5% WL goal increased the odds of meeting the 12-month 5% WL goal. For those not meeting the 6-month WL goal, maintenance session attendance did not improve odds of 12-month WL success. Medicare-eligible adults ≥65 years were more likely to meet the 12-month WL goal (odds ratio = 3.03, 95% CI, 1.58-5.81) versus Conclusions The results of this study provide important information regarding participant attendance and WL for providers offering DPP-based lifestyle intervention programs across the country who are seeking Medicare reimbursement. Understanding Medicare reimbursement-defined success will allow these providers to focus on and develop strategies to enhance program effectiveness and sustainability.

Nearly 50% of US adults >60 years have metabolic syndrome (MetS), which is linked to heart disease and diabetes. We evaluated if changes in cardiometabolic measures during a behavioral weight loss intervention for older adults differed by baseline MetS status (+ vs. -). The Pitt Retiree Study (PRS) was a 1-year lifestyle intervention trial adapted from DPP for adults 65+ years at high cardiometabolic risk. Participants attended 12 in-person group sessions, then were randomized to a monthly follow-up mode (phone or newsletter). Goals included 7% weight loss by 4 months via reduced calorie/fat intake, increased lean protein, and aerobic/strength training. Analyses include women only as 77% of PRS was female and sex differences in lipid metabolism exist. Participants (n=238) were mean (SD) age 71.1 (4.2), BMI 33.8 (5.4), and 67% had MetS at baseline. Regression models were used to compare change in cardiometabolic measures at 12 months in -MetS vs. +MetS (Table). Mean triglycerides (TG) decreased more in +MetS than -MetS while changes in other cardiometabolic measures did not differ between groups. -MetS had normal mean TG at baseline with little scope to improve, while +MetS had controlled blood pressure (BP) and LDL due to greater use of BP and lipid-lowering drugs. Nevertheless, both groups showed favorable cardiometabolic changes following lifestyle intervention. Disclosure H. J. Stern: None. R. G. Miller: None. T. J. Orchard: None. T. Costacou: None. E. M. Venditti: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R18DK096405)

Physical function, health-related quality of life (HRQoL), and depressive symptoms are key outcomes for older adults (≥65y) enrolled in behavioral weight management, but less is known about relationships among these variables. We evaluated associations between changes in these measures after a 1-year DPP-based lifestyle program. Participants (N=322) were M±SD age 71.2y±4.3, BMI 33.8±5.1, 77% women, 13% Black, averaged 4 chronic conditions, and 31% had prediabetes. Most took blood pressure (67%) and lipid (52%) medications. Participants attended 12 in-person weekly groups, then were randomized to continued monthly contact by phone or newsletter, losing 7.4% (CI) (-8.9, -5.9) and 6.1% (-8.6, -3.6) of weight at 1 year, respectively. Goals included reducing calorie/fat intake, increasing lean protein, ≥150 minutes aerobic activity/week, and strength training. Physical function was measured via Short Physical Performance Battery (SPPB) gait speed, chair rise, and balance tests, perceived HRQoL via SF-12 Physical and Mental Component Summary (PCS and MCS), and mood via Center for Epidemiologic Studies Depression Scale (CES-D) at pre- and post-intervention. Associations between baseline-12 month changes in SPPB, HRQoL and CES-D were estimated in mixed-effect models. SPPB improved by 0.3±1.4 (p=0.001) in phone and 0.3±1.7 (p=0.02) in newsletter. Increased SPPB was associated with improved PCS (β=1.18, SE=0.20, p Disclosure H. J. Stern: None. R. G. Miller: None. R. P. K. Conlon: None. M. D. Levine: None. M. D. Marcus: Advisory Panel; Self; Weight Watchers International, Inc. E. M. Venditti: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R18DK096405)

Lifestyle changes may reduce the burdens of diabetes and cancer. We examined how changes in the 2018 WCRF/AICR Score, reflecting key cancer prevention recommendations, are associated with diabetes risk. The Diabetes Prevention Program (DPP) randomized adults with prediabetes to a lifestyle intervention (ILS), metformin (MET), or placebo (PLB) for a mean of 3.2 years, with follow-up in DPPOS for 11 years. The Score includes 7 components: weight, physical activity, plant-based diet, red/processed meat, sugar-sweetened drinks, fast foods, and alcohol (0-7 points, with 7 as the best total score). Scores were estimated at years 0, 1, 5, 6, 9, and 15 for participants with complete baseline data (N = 3,147). Covariates included sex, age, race/ethnicity, marital status, education, family history of diabetes, hormone therapy (females), and energy intake. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) stratified by treatment group estimated the association of Score changes with diabetes risk in DPP and DPPOS within and between groups. There were significant Score improvements within all groups over 15 years (p < 0.001); the differences between groups were only significant after 1 year (p < 0.001; 15 years: p = 0.137). For every 1-unit improvement in Score during DPP, there was a 29% and 16% lower diabetes risk in ILS (95% CI: 0.58 - 0.88) and PLB (95% CI: 0.72 - 0.99), respectively, and no significant association in MET. The time-dependent Score improvements in ILS and PLB were significantly associated with lower diabetes risk through year 15 (ILS HR: 0.86, 95% CI 0.77 - 0.96; PLB HR: 0.85, 95% CI 0.76 - 0.95). Changes in weight, physical activity, and plant-based diet appeared to be drivers of the Score’s effect. Findings suggest that Score improvements are associated with a long-term, lower risk for diabetes among adults with prediabetes. Future research can explore how this risk reduction impacts cancer risk. Disclosure M. M. M. Shams-white: None. B. M. Heckman-stoddard: None. D. Research group: None. A. H. Tjaden: None. S. Edelstein: None. S. Bassiouni: None. C. Kim: None. X. Pi-sunyer: None. K. A. Temple: None. E. M. Venditti: None. J. Reedy: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK048489)

Introduction: The CDC established the National Diabetes Prevention Program (NDPP) initiative in 2010, leading to implementation of numerous group-based lifestyle interventions, such as the 12-month Group Lifestyle Balance (GLB) program, in community and clinical settings. Heterogeneity in weight outcomes is common. While evidence suggests that session attendance is associated with greater weight loss, some participants do not achieve weight loss even with high session attendance. Conversely, some may achieve clinically significant weight loss (≥5%) with lower attendance. In this study, we sought to identify and characterize such paradoxical interventional outcomes. (i.e., high session attendance and Hypothesis: No a priori hypotheses. Methods: We conducted a longitudinal descriptive analysis of overweight/obese GLB participants using electronic health record data from an integrated healthcare delivery system in Northern California (2010-2017). We focused on the 12-week intensive core phase of the curriculum because prior studies show that weight loss outcomes achieved during this period are highly correlated with long-term weight loss. We categorized patients into 4 mutually exclusive groups by session attendance ( Results: Among 1,818 evaluable participants, we identified 870 (47.9%) with paradoxical outcomes. Of these, 104 (12.0%) achieved ≥5% weight loss with Conclusions: Nearly half of all GLB participants in this integrated health system had paradoxical outcomes, with more than 40% classified as paradoxical non-responders. These results suggest that session attendance may not be as sensitive a predictor of weight outcomes as previously thought, and other approaches are needed to understand the complex factors influencing goal attainment in behavioral lifestyle programs.

Background Although Latino men have the highest prevalence (45%) of obesity among all men in the United States, traditional weight loss interventions have not effectively engaged this hard-to-reach and diverse group. Offering choices among technology-mediated weight loss interventions may offer advantages. Objective The aim of this study is to examine Latino men’s preferences among 3 weight loss intervention options. We also examined whether attendance in group sessions (videoconference and in person) and weight loss differed according to intervention choice. Methods Latino men (n=200; mean age 47.3, SD 11.8 years) participated in a comparative effectiveness trial based on primary care and were randomized to receive the 1-year HOMBRE (Hombres con Opciones para Mejorar su Bienestar para Reducir Enfermedades Crónicas; English translation: Men With Options to Improve Their Well-being and Reduce Chronic Disease) intervention. HOMBRE is a weight loss intervention that offers 3 delivery options. During an orientation session, a trained bilingual coach helped men select 1 of the 3 intervention options that differed in coach, peer support, and available language. We used canonical discriminant analysis to assess multivariate associations of demographic, clinical, employment, cultural, and technology use and access factors with men’s intervention choices. We used generalized linear models to estimate weight loss at 6, 12, and 18 months for men in each intervention option. Results Among Latino men, 28% (56/200) chose videoconference groups, 31% (62/200) chose web-based videos, and 41% (82/200) chose in-person groups. The canonical discriminant analysis identified 1 orthogonal dimension that distinguished between men who chose an in-person group and men who chose web-based videos. Men who were older, spoke Spanish, and did not use a computer frequently had a higher probability of choosing in-person groups versus web-based videos. For men who selected a group delivery option, 86.9% (107/123) attended ≥25% of the sessions, 83.7% (103/123) attended ≥50% of the sessions, and 73.2% (90/123) attended ≥75% of the sessions, with no differences by type of group (videoconference or in person). Men who chose videoconference and in-person group sessions lost significantly more weight at 6 months (both P Conclusions There were significant differences according to demographic, employment, cultural, and technology use factors between men who chose 1 of the 3 intervention options. Men who chose one of the group-based options (videoconference or in person) lost significantly more weight than those who chose web-based videos. Providing options that accommodate the diversity of Latino men’s preferences is important for increasing engagement in behavioral interventions. Trial Registration ClinicalTrials.gov NCT03092960; https://clinicaltrials.gov/ct2/show/NCT03092960

BACKGROUND Although Latino men have the highest prevalence (45%) of obesity among all men in the United States, traditional weight loss interventions have not effectively engaged this hard-to-reach and diverse group. Offering choices among technology-mediated weight loss interventions may offer advantages. OBJECTIVE The aim of this study is to examine Latino men’s preferences among 3 weight loss intervention options. We also examined whether attendance in group sessions (videoconference and in person) and weight loss differed according to intervention choice. METHODS Latino men (n=200; mean age 47.3, SD 11.8 years) participated in a comparative effectiveness trial based on primary care and were randomized to receive the 1-year HOMBRE (Hombres con Opciones para Mejorar su Bienestar para Reducir Enfermedades Crónicas; English translation: Men With Options to Improve Their Well-being and Reduce Chronic Disease) intervention. HOMBRE is a weight loss intervention that offers 3 delivery options. During an orientation session, a trained bilingual coach helped men select 1 of the 3 intervention options that differed in coach, peer support, and available language. We used canonical discriminant analysis to assess multivariate associations of demographic, clinical, employment, cultural, and technology use and access factors with men’s intervention choices. We used generalized linear models to estimate weight loss at 6, 12, and 18 months for men in each intervention option. RESULTS Among Latino men, 28% (56/200) chose videoconference groups, 31% (62/200) chose web-based videos, and 41% (82/200) chose in-person groups. The canonical discriminant analysis identified 1 orthogonal dimension that distinguished between men who chose an in-person group and men who chose web-based videos. Men who were older, spoke Spanish, and did not use a computer frequently had a higher probability of choosing in-person groups versus web-based videos. For men who selected a group delivery option, 86.9% (107/123) attended ≥25% of the sessions, 83.7% (103/123) attended ≥50% of the sessions, and 73.2% (90/123) attended ≥75% of the sessions, with no differences by type of group (videoconference or in person). Men who chose videoconference and in-person group sessions lost significantly more weight at 6 months (both PP=.02 and P=.04, respectively) than those who chose web-based videos. Men who chose in-person group sessions also lost significantly more weight at 12 months (P=.008) than those who chose web-based videos. CONCLUSIONS There were significant differences according to demographic, employment, cultural, and technology use factors between men who chose 1 of the 3 intervention options. Men who chose one of the group-based options (videoconference or in person) lost significantly more weight than those who chose web-based videos. Providing options that accommodate the diversity of Latino men’s preferences is important for increasing engagement in behavioral interventions. CLINICALTRIAL ClinicalTrials.gov NCT03092960; https://clinicaltrials.gov/ct2/show/NCT03092960

Physical activity (PA) is associated with greater fatigability in older adults, little is known about magnitude, shape, timing and variability of the entire 24-h rest–activity rhythm (RAR) associated with fatigability. We identified which features of the 24-h RAR pattern were independently and jointly associated with greater perceived physical fatigability (Pittsburgh Fatigability Scale, PFS, 0–50) in older adults (n = 181, 71.3 ± 6.7 years). RARs were characterized using anti-logistic extended cosine models and 4-h intervals of PA means and standard deviations across days. A K-means clustering algorithm approach identified four profiles of RAR features: “Less Active/Robust”, “Earlier Risers”, “More Active/Robust” and “Later RAR”. Quantile regression tested associations of each RAR feature/profile on median PFS adjusted for age, sex, race, body mass index and depression symptomatology. Later rise times (up mesor, β = 1.38, p = 0.01) and timing of midpoint of activity (acrophase, β = 1.29, p = 0.01) were associated with higher PFS scores. Lower PA between 4 a.m. and 8 a.m. was associated with higher PFS scores (β = −4.50, p = 0.03). “Less Active/Robust” (β = 6.14, p = 0.01) and “Later RAR” (β = 3.53, p = 0.01) patterns were associated with higher PFS scores compared to “Earlier Risers”. Greater physical fatigability in older adults was associated with dampened, more variable, and later RARs. This work can guide development of interventions aimed at modifying RARs to reduce fatigability in older adults.

Background Sex influences health and related behaviors due to biological and psychosocial/socioeconomic factors. Assessing sex-specific responses to integrated treatment for comorbid obesity and depression could inform intervention targeting. Purpose To test (a) whether sex moderates the effects of integrated collaborative care on weight and depression outcomes through 24 months and (b) whether treatment response at 6 months predicts 12 and 24 month outcomes by sex. Methods Secondary data analyses on weight and depression severity (SCL-20) measured over 24 months among 409 adults with obesity and depression in the Research Aimed at Improving Both Mood and Weight trial. Results Men achieved significantly greater weight reductions in intervention versus usual care than women, whereas women achieved significantly greater percentage reductions in SCL-20 than men at both 12 and 24 months. In logistic models, at 80% specificity for correctly identifying participants not achieving clinically significant long-term outcomes, women who lost Conclusions Sex modified the integrated treatment effects for obesity and depression. Sex-specific responses at 6 months predicted clinically significant weight loss and depression outcomes through 24 months. Based on early responses, interventions may need to be tailored to address sex-specific barriers and facilitators to achieving healthy weight and depression outcomes at later time points. Clinical Trial Registration NCT02246413 (https://clinicaltrials.gov/ct2/show/NCT02246413).

Background: Integrated treatments for depression (and associated anxiety) and obesity are lacking; mechanisms are poorly investigated. This mechanistic pilot trial tested the degree to which engaging pre-specified neural targets at 2 months produces desired outcomes at 6 months. Methods: Adults with a body mass index (BMI) of ≥30 (≥27, if Asian) and Patient Health Questionnaire-9 (PHQ-9) score of ≥10 were recruited from academic internal medicine clinics between March 1, 2019 and March 19, 2020, and followed for 6 months until August 31, 2020. Participants were randomized to receive usual care (n=35) or an integrated collaborative care intervention (n=71), providing 6 problem-solving therapy (PST) sessions for depression by 2 months, 3 additional PST sessions and 11 home videos on lifestyle changes for weight loss by 6 months. Outcomes were changes in BMI, Depression Symptom Checklist 20-item (SCL-20) scores, and Generalized Anxiety Disorder Scale (GAD-7) scores at 6 months. Neural targets were changes in affective, cognitive control, and default mode circuits by functional neuroimaging at 2 months. Outcomes: Among 106 participants (mean [SD] age 47.0 [11.9] years, 76% women, 55% Blacks, 20% Latino, BMI 37.1 [6.0], SCL-20 1.2 [0.7], GAD-7 6.9 [4.8]), 86.8% completed the trial. The intervention led to significant reductions in SCL-20 (-0.3 [95% CI: -0.6, -0.1]) and GAD-7 (-2.9 [-4.7, -1.1]), but not BMI, at 6 months compared with usual care. Changes in the activation or functional connectivity of neural targets in the negative affect (anterior insula, subgenual and pregenual ACC, amygdala) and cognitive control circuits (dlPFC, dACC) at 2 months significantly correlated with changes in GAD-7, but not SCL-20 or BMI, at 6 months, and the correlations differed by the intervention vs. usual care. Effect sizes were medium to large (0.41ꟷ1.18 SDs). Changes in the neural targets of the cognitive control circuit, but not the negative affect circuit, at 2 months differed by treatment group. Effect sizes were medium (0.58ꟷ0.79 SDs). Interpretation: Short-term changes in the cognitive control circuit mediated changes in anxiety symptoms, suggesting possible neural mechanisms to target for enhanced treatment effect. Clinical Trial Registration Details: ClinicalTrials.gov Identifier: NCT03841682. Funding Information: National Heart, Lung, and Blood Institute grant number UH2HL132368 and UH3HL132368. Declaration of Interests: Dr. Jun Ma is a paid scientific consultant for Health Mentor, Inc. (San Jose, CA). Dr. Leanne M. Williams is on the Scientific Advisory Board for One Mind Psyberguide and the External Advisory Board for the Laureate Institute for Brain Research. Dr. Olusola A. Ajilore is the co-founder of Keywise AI and serves on the advisory boards of Blueprint Health and Embodied Labs. The other authors report no conflicts of interest. Dr. Thomas Kannampallil is a paid consultant for Pfizer, Inc, outside of this work Ethics Approval Statement: The Institutional Review Boards for the University of Illinois at Chicago and Stanford University approved the study. All participants provided written consent.

Background Depression exerts a staggering toll that is worsened with co-occurring chronic conditions such as obesity. It is imperative to develop more effective interventions for depression and to identify objective and biological plausible neural mechanisms to understand intervention outcomes. The current study uses functional neuroimaging to determine whether a behavioural intervention changes the negative affect circuit and whether these changes relate to subsequent improvements in both symptom and problem-solving outcomes in depressed patients with co-occurring obesity. Methods This study (‘ENGAGE’) was a pre-planned element of the randomized controlled trial, ‘RAINBOW’ (ClinicalTrials.gov NCT02246413). 108 depressed patients with obesity were randomized to receive an integrated collaborative care intervention (I-CARE) or usual care. Participants underwent functional neuroimaging using an established facial emotion task at baseline and two months (coinciding with the first two months of intervention focused on problem-solving therapy (‘PST’)). Amygdala, insula and anterior cingulate cortex activation was extracted using pre-planned definitions and standardized methods. The primary health and behavioural outcomes were depression symptom severity and problem-solving ability respectively, assessed at baseline, the main 6-month outcome point and at 12-month follow up. Mediation analyses used an intent-to-treat approach. Findings PST, relative to usual care, reduced amygdala activation engaged by threat stimuli at two months. This reduction mediated subsequent improvements in depression severity in an intervention-dependent manner. PST did not change insula activation at two months but did temper the strength of the relationship between insula activation and improvements in problem-solving ability. Interpretation The negative affect circuit may be an important neural target and potential mediator of PST in patients with comorbid obesity. Funding US National Institutes of Health/National Heart Lung and Blood Institute R01 HL119453 and UH2/UH3 HL132368

Background Examining variability in the presenting symptoms of depression may be particularly important in characterizing depression in patients with comorbid conditions such as obesity. Identifying the underlying constructs of depression in such patients may produce phenotypic information to aid diagnosis and treatment decisions. Objective To examine the latent factors of symptoms using the depression Symptom Checklist (SCL-20) and the Patient Health Questionnaire (PHQ-9), separately, in patients with obesity and elevated depressive symptoms. Methods Exploratory factor analysis (EFA) was performed on baseline data from 409 patients with obesity and elevated depressive symptoms recruited in primary care. Bootstrap analysis was performed to estimate the precision and potential replicability of identified latent factors. Results Participants (70% women, mean age of 51.0 ± 12.1 years) had moderate depression. EFA of the SCL-20 suggested two reliable factors: dysphoric mood (71% of the variance) and anhedonia (15% of the variance). EFA of the PHQ-9 yielded one factor: dysphoric mood (87% of the variance). Bootstrapped results supported the replicability of these results. The top most endorsed symptoms were feeling low energy, overeating and disturbed sleep. Limitations The generalizability of these findings to severe depression may be limited. Conclusions Patients with elevated depressive symptoms and obesity present with heterogeneous symptoms. The SCL-20 seems more sensitive than the PHQ-9 for differentiating symptom profiles in this population. Some possible reasons include: 1) differences in number of scale items, and 2) differences in the aspects of depression they tap into; the SCL-20 measures the severity of symptoms, whereas the PHQ-9 measures the frequency of symptoms.

Objective: Across the DPP follow-up, cumulative diabetes incidence remained lower in the lifestyle compared to placebo and metformin randomized groups and could not be explained by weight. Collection of self-reported PA (yearly) with cross-sectional objective PA (in follow-up) allowed for examination of PA and its long-term impact on diabetes prevention. Research Design and Methods: Yearly self-reported PA and diabetes assessment, OGTT, (fasting glucose semi-annually) was collected for 3232 participants with one accelerometry assessment 11-13 years after randomization (n=1,793). Mixed models determined PA differences across treatment groups. The association between PA and diabetes incidence was examined using Cox proportional hazards models. Results: There was a 6% decrease (Cox proportional HR 0.94 [0.92, 0.96]; P< 0.001) in diabetes incidence per 6 MET-hrs/week increase in time-dependent PA for the entire cohort over an average 12 years (controlled for age, sex, baseline PA and weight). The effect of PA was greater (12% decrease) among participants less active at baseline ( Conclusions: PA was inversely related to incident diabetes in the entire cohort across the study with cross-sectional accelerometry results supporting these findings. This highlights the importance of PA within lifestyle intervention efforts designed to prevent diabetes and urge health-care providers to consider both PA and weight when counseling high-risk patients.

Background: Behavioral interventions for obesity have modest and variable effectiveness. Emotion dysregulation may hinder effective weight loss interventions, especially among those with comorbid depression. Whether neural mechanisms related to emotion dysregulation mediate the effect of behavioral intervention on improving health behaviors in obesity combined with depression is unknown. Hyperactivation of the amygdala and loss of functional connectivity with the anterior cingulate regions are neural characteristics of unhealthy responses to negative emotion and accompanying emotion dysregulation. Methods: Using data from a randomized clinical trial of 108 primary care adult patients with obesity and depression, we investigated whether changes in amygdala activity and connectivity following problem solving therapy for depression over 2 months mediate weight loss, physical activity, and/or dietary outcomes at 6 and 12 months. Results: Compared with controls (n=49), intervention participants (n=59) had a significant blunting of the otherwise unhealthy increase in activity of the bilateral amygdala at 2 months (right: -0.83, 95% CI -1.55 to -0.11; left: -0.86, -1.63 to -0.10). While increases in amygdala activity significantly correlated with decreases in leisure-time physical activity levels and total energy expenditure at 12 months in the control group, this relationship was tempered or reversed among intervention participants (for physical activity, right: usual care -692.9, -1365.3 to -20.6; interaction 652.2, -115.4 to 1419.9; left: usual care -686.0, -1127.9 to -244.1; interaction 664.7, 73.1 to 1256.4; for energy expenditure, right: usual care -1.82, -3.08 to -0.56; interaction 1.94, 0.50 to 3.38; left: usual care -1.72, -2.51 to -0.93; interaction 1.89, 0.84 to 2.94). Compared with controls, intervention participants had a significant increase of the otherwise unhealthy loss of amygdala-subgenual anterior cingulate connectivity at 2 months (0.78, 0.05 to 1.52). This increase in functional connectivity significantly correlated with a decrease in BMI at 6 months among intervention participants (usual care 0.04, -0.42 to 0.50; interaction -0.61, -1.20 to -0.02) and an increase in fruit and vegetable intake at 12 months across all participants (usual care 1.42, 0.27 to 2.57; interaction -0.95, -2.36 to 0.46). Conclusions: These findings highlight potential neural mechanism for optimizing the efficacy of behavioral intervention in comorbid obesity and depression.Trial registration: ClinicalTrials.gov#NCT02246413.URL: https://clinicaltrials.gov/ct2/show/NCT02246413.

Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.

Adherence to a Mediterranean (Med) diet pattern, characterized by increased intake of fruits, nuts/seeds, vegetables, legumes, whole grains, seafood, yogurt and vegetables, and decreased intake of red/processed meats, refined grains, starches and added sugars, is associated with reduced cardiometabolic risk independent of total calorie intake or single nutrients. We examined whether adherence to Med diet was associated with risk factor change in the context of a behavioral weight management trial for U.S. community-dwelling older adults at elevated diabetes and cardiovascular risk. The Pitt Retiree Study (n=322) examined the impact of 12 weekly group lifestyle sessions on weight and cardiometabolic risk (BMI, waist, glucose, lipids, and blood pressure) in older adults (age 65-80 yrs). Dietary goals included calorie reduction, Disclosure R.G. Miller: None. E.M. Venditti: None. M.D. Marcus: None. L.J. Germeroth: None. R.P.K. Conlon: None. M.D. Levine: None. T. Costacou: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R18DK096404)

The DPP lifestyle intervention showed that meeting weight loss (WL) and activity goals can prevent/delay T2D. The success of community translated versions of it (e.g., Group Lifestyle Balance, DPP-GLB) has led to Medicare reimbursement based on session attendance (at 6 and 12 months) and participant success at meeting a 5% WL goal at 12 months. Although attendance has been suggested to be related to WL success, the impact of the 6 monthly maintenance sessions (mos 7-12) after the more frequent 16 core sessions (mos 0-6) on one-year WL is not known. This effort examines how maintenance session attendance and WL goal status at 6 months in DPP-GLB affects achievement of the 12-month 5% WL goal. Data were combined from two identical intervention trials that delivered the 12-month DPP-GLB in a community setting to overweight/obese adults (mean age 62 years, 76% women) with prediabetes and/or metabolic syndrome. Participants who attended ≥4 core sessions during the first 6 months and had complete data on maintenance attendance and WL were included (n=238). Meeting the 6-month WL goal was associated with greater odds of meeting the 12-month WL goal (p Disclosure J. Napoleone: None. R.G. Miller: None. S. Devaraj: None. B. Rockette-Wagner: None. V.C. Arena: None. E.M. Venditti: None. K. Kramer: None. A. Kriska: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R18DK100933, R18DK081323)

Objective Obesity and depression are prevalent and often co-occurring conditions in the United States. The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized trial demonstrated the effectiveness of an integrated intervention for adults with both conditions. Characterizing the intervention's economic effects is important for broader dissemination and implementation. Methods This study evaluated the cost (2018 US dollars) and health-related quality of life (HRQoL) impacts during RAINBOW's first year, comparing intervention (n = 204) and usual-care groups (n = 205). Outcomes included intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes from baseline using Euroqol-5D US utility weights. Results RAINBOW's 1-year delivery cost per person was $2,251. Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027). Annual antidepressant medication spending had a larger, nonsignificant increase ($89 [95% CI: -$20 to $197]; P = 0.109). Annual spending on medical care services had a smaller, nonsignificant decrease (-$54 [95% CI: -$832 to $941]; P = 0.905). HRQoL had a nonsignificant increase (0.011 [95% CI: -0.025 to 0.047]; P = 0.546). Conclusions The RAINBOW intervention's economic value will depend on how its 1-year improvements in obesity and depression translate into long-term reduced morbidity, delayed mortality, or averted costs.

The RAINBOW trial demonstrated that an integrated collaborative care intervention was effective for improving weight and depression. This study examined mediation of the treatment effect by a priori specified lifestyle behaviors and cognitive functioning. Participants were randomized to a 12-month integrated intervention (n = 204) or usual care (n = 205). Body mass index (BMI) and 20-item Depression Symptom Check List (SCL-20) were co-primary outcomes (Y). To examine mediation, we assessed (a) the effect of the integrated intervention (X) on lifestyle behaviors (diet and physical activity) and cognitive functioning (problem-solving; M, X→M path a) and (b) the association of these behaviors with BMI and SCL-20 (M→Y path b). Mediation existed if paths a and b were significant or if path a and the product of coefficients test (paths a and b) were significant. Compared with usual care, the intervention led to significant improvements in leisure time physical activity (201.3 MET minutes/week [SD, 1,457.6]) and total calorie intake (337.4 kcal/day [818.3]) at 6 months but not 12 months (path a). These improvements were not significantly associated with improvements in BMI or SCL-20 (path b). However, avoidant problem-solving style score and increased fruit and vegetable intake significantly correlated with improvements in BMI at 6 and 12 months, respectively. Also, increased fruit and vegetable intake, higher dietary quality, and better problem-solving abilities significantly correlated with improvements in SCL-20 at 6 and 12 months. These findings did not support the hypothesized mediation, but suggest lifestyle behaviors and cognitive functioning to target in future intervention optimization.

Introduction: Obesity and depression often co-occur, especially in women. Efficacious treatments exist for both conditions, but treatment outcomes vary. Assessing sex-specific responses to integrated therapy of these conditions could inform opportunities for tailoring. Hypothesis: Sex will significantly moderate the effects of an integrated collaborative care intervention on weight loss and depression outcomes through 24 months. Short-term treatment response at 6 months will reliably predict 12- and 24-month outcomes by sex. Methods: We conducted secondary analyses using data from the RAINBOW trial, which demonstrated efficacy of an integrated collaborative care intervention at reducing weight (BMI) and depression severity (SCL-20) at 12 months relative to usual care in adults with obesity and depression. Linear mixed models were used to assess treatment effects by sex, an a priori hypothesized biological moderator, on BMI and SCL-20 at 6, 12, and 24 months. Areas under the receiver operating characteristic curves (AUCs) based on logistic regressions were used to assess sex-specific thresholds of weight loss (%) and SCL-20 reduction at 6 months that reliably predicted clinically significant weight loss (i.e., ≥5% of baseline weight) and depression response (i.e., ≥50% decrease in SCL-20 scores) at 12 and 24 months. Results: Sex significantly moderated the treatment effects on BMI and SCL-20. Compared with women, men achieved significantly greater reductions in BMI at 6, 12, and 24 months in the intervention relative to usual care. Compared with men, women achieved significantly greater reductions in SCL-20 at 12 months only in the intervention relative to usual care. AUCs in the logistic models were similar for both sexes: >0.82 at 12 months and >0.65 at 24 months predicting clinically significant weight loss; >0.70 at 12 months and >0.67 at 24 months predicting clinically significant depression response. With 80% specificity to ensure good probability of correctly identifying participants not achieving longer-term outcomes of clinical significance, women who lost 2.5-3.0% weight and men who lost 3.4-4.1% weight at 6 months were likely to achieve ≥5% weight loss at 12 and 24 months. Similarly, women who reduced SCL-20 by 0.70 and men who reduced by 0.60-0.65 were likely to achieve ≥50% decrease in SCL-20 at 12 and 24 months. Conclusions: The treatment effects of this integrated intervention for obesity and depression differed significantly by sex, with men showing greater weight loss and women showing greater depression reduction. Sex-specific short-term responses at 6 months were identified for predicting clinically significant weight loss and depression outcomes at 12 and 24 months. Results suggest that sex may be an important tailoring variable when designing collaborative care interventions.

Introduction: Neural mechanisms underlying behavior therapy in obesity are poorly understood, particularly in patients with comorbid depression. Putative targets include neural circuits for conscious and nonconscious emotion regulation. Hypothesis: Changes in a priori neural circuits for emotion regulation from baseline (0) to 2 mo (mediators, M) mediate changes in BMI, physical activity, and eating behaviors from 0 to 6 or 12 mo (outcomes, Y). Methods: In a trial of integrated behavior therapy, adults with obesity and depression were randomized to intervention (n=59) or usual care (n=49). The yearlong intervention included 6 in-person problem solving therapy (PST) sessions for depression by 2 mo, 3 additional PST sessions for depression and 11 home videos on lifestyle changes for weight loss by 6 mo, and 6 maintenance calls by 12 mo. Participants completed validated conscious and nonconscious facial emotion viewing tasks in fMRI at 0 and 2 mo (time point corresponding to initial PST for depression in the intervention) and weight and height (baseline only) measurements, 7-day physical activity recalls, and 24-hour dietary recalls at 0, 6, and 12 mo. Analyses tested mediation as showing both a significant treatment effect (X) of the intervention vs. usual care on the mediator (X->M, path a ) and a significant correlation of the mediator with the outcome either as a main effect or an interaction effect by treatment group (M->Y, path b ). Results: Compared with usual care, the intervention led to significantly reduced nonconscious reactivity to threat-related facial emotions (fear, anger) at 2 mo for the left (-0.89, 95% CI -1.64 to -0.14; P =.02) and right amygdala (-0.84, 95% CI -1.54 to -0.13; P =.02) ( path a ). These reductions correlated significantly with increased leisure-time physical activity (MET minutes/wk) at 12 mo: main effect -686.0 (95% CI -1127.9 to -244.1; P =.003) and interaction effect 664.7 (95% CI 73.1 to 1256.4; P =.03) for the left amygdala and main effect -692.9 (95% CI -1365.3 to -20.6; P= .04) for the right amygdala. Similarly, the reductions correlated significantly with increased energy expenditure (kcal/kg/d) at 12 mo: main effect -1.72 (95% CI -2.49 to -0.95; P P P =.006) and interaction effect 1.94 (95% CI 0.50 to 3.38; P =.01) for the right amygdala ( path b ). Nonconscious reactivity to threat in bilateral amygdala did not correlate significantly with changes in BMI or eating behaviors. Conclusions: Reduced nonconscious reactivity to threat in bilateral amygdala in response to initial PST for depression significantly mediated improvements in leisure-time physical activity and energy expenditure. Results advance the understanding of neural mechanisms underlying behavior therapy in obesity and inform intervention optimization to enhance efficacy.

Summary Mindfulness and slow eating techniques are commonly recommended to achieve weight loss within behavioural weight management programmes; yet the role of these eating strategies on acute energy intake (EI) and satiety are not clear. This study investigated the effects of mindful and slow eating strategies on acute EI and satiety. Twenty‐four participants were randomized to one of three eating conditions (EAT, MIND, SLOW). For the EAT condition, participants were instructed to eat as they normally would for both test meal sessions. For the SLOW condition, participants were instructed to eat as they normally would for their first test meal session and to slow their eating for the second test meal session. For the MIND condition, participants were instructed to eat as they normally would during their first test meal session and were given brief instructions on mindful eating for their second test meal session. For each condition, participants were provided ad libitum access to a test meal, and EI was calculated based upon food consumed. Participants rated their level of satiety following each meal. There were no significant differences in EI between eating strategy conditions. There was a trend towards a decrease in energy intake in the MIND condition compared with the EAT condition and a prevention of increased intake in the SLOW condition. There were no significant differences in ratings of satiety between conditions. Although, neither mindful nor slow eating strategies significantly decreased acute EI or satiety; the results suggest that both strategies blunted the increase in EI observed in EAT that occurred across two eating episodes, which may suggest that these strategies can be important for modifying eating behaviour that may contribute to body weight regulation. Additional appropriately designed studies investigating these strategies appear warranted to confirm these findings.

The purpose of this chapter is to review several individual-level, and potentially modifiable, behavioral factors known to be involved in the etiology of cardiometabolic impairments and type 2 diabetes in the context of aging. There is widespread acknowledgement that the dual epidemics of obesity and type 2 diabetes are interrelated and that lifestyle behaviors associated with excess weight play an integral role in the development, course, and outcomes of the physiological disease process. The study of diet, eating habits, and physical activity within a social-ecological framework has been central to advancing the scientific understanding of obesity and type 2 diabetes for over 50 years. The role of other behavioral lifestyle factors such as sleep, smoking, alcohol use, and psychosocial stress is less well understood but highly relevant because of their biological associations with obesity and the regulation of glucose and insulin. Furthermore, examining the individual-level lifestyle behaviors and associated pathophysiology (i.e., “biobehavioral factors”) most frequently implicated in the development and course of obesity and type 2 diabetes is essential for improved chronic disease prevention and control. Therefore, this chapter has three primary aims. We will (1) review and discuss the biological impact of several key lifestyle behaviors that have been shown to be significant in weight self-regulation and discuss their biological relationship to type 2 diabetes in adults; (2) critically evaluate research findings of the last 10 years that highlight the importance and significance of the biobehavioral relationships associated with type 2 diabetes; and (3) summarize promising research directions that are likely to yield important insights regarding behavioral lifestyle factors for type 2 diabetes prevention and management.

IntroductionThe RAINBOW randomized clinical trial validated the efficacy of an integrated collaborative care intervention for obesity and depression in primary care, although the effect was modest. To inform intervention optimization, this study investigated within-treatment variability in participant engagement and progress.MethodsData were collected in 2014-2017 and analyzed post hoc in 2018. Cluster analysis evaluated patterns of change in weekly self-monitored weight from week 6 up to week 52 and depression scores on the Patient Health Questionnaire-9 (PHQ-9) from up to 15 individual sessions during the 12-month intervention. Chi-square tests and ANOVA compared weight loss and depression outcomes objectively measured by blinded assessors to validate differences among categories of treatment engagement and progress defined based on cluster analysis results.ResultsAmong 204 intervention participants (50.9 [SD, 12.2] years, 71% female, 72% non-Hispanic White, BMI 36.7 [6.9], PHQ-9 14.1 [3.2]), 31% (n = 63) had poor engagement, on average completing self-monitored weight in ConclusionsParticipants demonstrating poor engagement or poor progress could be identified early during the intervention and were more likely to fail treatment at the end of the intervention. This insight could inform individualized and timely optimization to enhance treatment efficacy.Trial registrationClinicalTrials.gov# NCT02246413.