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Context: Higher levels of insulin-like growth factor-1 (IGF-1) are associated with increased risk of cancers and higher mortality. Therapies that reduce IGF-1 have considerable appeal as means to prevent recurrence., Design: Randomized, 3-parallel-arm controlled clinical trial., Interventions and Outcomes: Cancer survivors with overweight or obesity were randomized to (1) self-directed weight loss (comparison), (2) coach-directed weight loss, or (3) metformin treatment. Main outcomes were changes in IGF-1 and IGF-1:IGFBP3 molar ratio at 6 months. The trial duration was 12 months., Results: Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years. At baseline, the average body mass index was 35 kg/m2; mean IGF-1 was 72.9 (SD, 21.7) ng/mL; and mean IGF1:IGFBP3 molar ratio was 0.17 (SD, 0.05). At 6 months, weight changes were -1.0% (P = 0.07), -4.2% (P < 0.0001), and -2.8% (P < 0.0001) in self-directed, coach-directed, and metformin groups, respectively. Compared with the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/mL, P = 0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, P = 0.011) at 3 months. The significant decrease of IGF-1 remained in participants with obesity at 6 months (mean difference in change: -7.2 ng/mL; 95% CI: -13.3 to -1.1), but not in participants with overweight (P for interaction = 0.045). There were no significant differences in changes between the coach-directed and self-directed groups. There were no differences in outcomes at 12 months., Conclusions: In cancer survivors with obesity, metformin may have a short-term effect on IGF-1 reduction that wanes over time., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

To determine whether initial engagement, continued participation, and weight loss vary by subsidy and promotional strategies in a beneficiary-based, commercial weight-loss programme. We conducted a retrospective analysis of data from 2013 to 2016. Our dependent variables included initial engagement (≥1 calls; ≥2 weights), coach calls and weight change. Our independent variables were subsidy strategy (total subsidy (n = 9) vs cost sharing (n = 3)) and combination of promotional-subsidy strategies (mixed campaign + total subsidy (n = 6) vs mass media + total subsidy (n = 3)). We used logistic and linear regression analyses adjusted for beneficiary factors and clustering by organization. From 12 participating organizations, 26 068 beneficiaries registered of which 6215 initially engaged. Cost sharing was associated with significantly greater initial engagement as compared to total subsidy (OR 3.73, P < 0.001); however, no significant between-group differences existed in calls or weight change. Mass media + total subsidy group had significantly greater calls and weight loss at 12 months compared to mixed campaign + total subsidy (-2.6% vs -1.8%, P = 0.04). Cost sharing may promote greater initial engagement, although does not contribute to better participation or weight loss relative to total subsidy. If organizations elect total subsidy, then pairing this strategy with a mass media campaign may promote greater participation and weight loss among beneficiaries., (© 2019 World Obesity Federation.)

Objective: Given the high prevalence of obesity and diabetes in patients with serious mental illness (SMI) and the lack of evidence on the effects of weight loss programs in SMI patients with diabetes, we evaluated the effectiveness of a behavioral weight loss intervention among SMI participants with and without diabetes., Research Design and Methods: Using data from ACHIEVE, a randomized controlled trial to evaluate the effects of a behavioral weight loss intervention among overweight/obese people with SMI, we assessed and compared weight change from baseline to 18 months in participants with and without diabetes using a longitudinal mixed-effects model., Results: Of the 291 trial participants, 82 (28.2%) participants had diabetes (34 and 48 in intervention and control groups, respectively) at baseline. Participants with diabetes were more likely to be taking antipsychotics (31.7% vs. 18.7%, P = 0.02). At 18 months, participants in the control group with diabetes lost 1.2 lb (0.6%) of body weight compared with 0.8 lb (0.7%) among those without diabetes. In the intervention group, participants with diabetes lost 13.7 lb (6.6%) of their initial body weight compared with 5.4 lb (2.9%) for those without diabetes. Corresponding net effects (intervention minus control) were 4.6 lb (2.2%) and 12.5 lb (6.0%) net weight reduction over 18 months in the no diabetes and the diabetes subgroups, respectively. However, the between-group difference in intervention effects was statistically nonsignificant (absolute weight change: P -interaction = 0.08; % weight change: P -interaction = 0.10)., Conclusions: A behavioral weight loss intervention is effective among overweight and obese individuals with SMI regardless of their diabetes status., (© 2019 by the American Diabetes Association.)

Background: Persons with serious mental illnesses (SMI) such as schizophrenia and bipolar disorder have an increased risk of obesity and related chronic diseases and die 10-20years earlier than the overall population, primarily due to cardiovascular disease. In the ACHIEVE trial, a behavioural weight loss intervention led to clinically significant weight loss in persons with SMI. As the field turns its attention to intervention scale-up, it is important to understand whether the effectiveness of behavioural weight loss interventions for people with SMI, like ACHIEVE, differ for specific subgroups., Methods: This study examined whether the effectiveness of the ACHIEVE intervention differed by participant characteristics (e.g. age, sex, race, psychiatric diagnosis, body mass index) and/or their weight-related attitudes and behaviours (e.g. eating, food preparation, and shopping habits). We used likelihood-based mixed effects models to examine whether the baseline to 18 month effects of the ACHIEVE intervention differed across subgroups., Results: No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined., Conclusions: These findings suggest that the ACHIEVE behavioural weight loss intervention is broadly applicable to the diverse population of individuals with SMI., (Copyright © 2019. Published by Elsevier Ltd.)

Objective: To evaluate the association between the patient-provider relationship, satisfaction with primary care provider's (PCP) involvement and weight loss in a practice-based weight loss trial., Methods: POWER was a practice-based randomized controlled behavioral weight loss trial. Participants completed questionnaires about patient-provider relationship and satisfaction with their PCPs' involvement in the trial. PCPs completed a demographics and practice survey. The main outcome was the mean weight change from baseline to 24 months. We created mixed-effect models, accounting for the random effects of patients clustering with the PCP and the repeated outcome assessments within patient over time, and adjusted for randomization assignment, age, gender, race and clinical site., Results: 347 (of 415) were included. Mean age was 54.8 years, mean BMI was 36.3 kg/m(2). Participants reported high quality patient-provider relationships (mean summary score=29.1 [range 14-32]). Patient-provider relationship quality was not associated weight loss in either the intervention or control groups. Among intervention participants, higher ratings of the helpfulness of the PCPs' involvement was associated with greater weight loss (p=0.005)., Conclusion: Patient-provider relationship quality was not associated with weight loss in a practice-based weight loss trial but rating PCPs as helpful in the intervention was associated with weight loss., Practice Implications: Partnering with PCPs to deliver weight loss programs may promote greater participant satisfaction and weight loss., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment., Purpose: The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations., Method: Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n = 501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n = 1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months., Results: In PREMIER, three distinct latent classes emerged: responders (45.9%), non-responders (23.6%), and early adherers (30.5%). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16%), non-responders (40%), early adherers (2%), and fruit/veggie only responders (41%). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes., Conclusion: Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes.

Objective: In behavioral studies of weight loss programs, participants typically receive interventions free of charge. Understanding an individual's willingness to pay (WTP) for weight loss programs could be helpful when evaluating potential funding models. This study assessed WTP for the continuation of a weight loss program at the end of a weight loss study., Methods: WTP was assessed with monthly coaching contacts at the end of the two-year Hopkins POWER trial. Interview-administered questionnaires determined the amount participants were willing to pay for continued intervention. Estimated maximum payment was calculated among those willing to pay and was based on quantile regression adjusted for age, body mass index, race, sex, household income, treatment condition, and weight change at 24 months., Results: Among the participants (N=234), 95% were willing to pay for continued weight loss intervention; the adjusted median payment was $45 per month. Blacks had a higher adjusted median WTP ($65/month) compared to Non-Blacks ($45/month), P=0.021., Conclusions: A majority of participants were willing to pay for a continued weight loss intervention with a median monthly amount that was similar to the cost of commercial weight loss programs., (© 2014 The Obesity Society.)

Objective: To examine the behavioral processes through which lifestyle interventions impacted weight loss., Methods: The analyses were limited to overweight and obese Black and White adults randomized to a PREMIER lifestyle intervention (N = 501). Structural equation modeling was conducted to test the direct and indirect relationships of session attendance, days of self-monitoring diet and exercise, change in diet composition and exercise, and 6-month weight change., Results: Greater session attendance was associated with increased self-monitoring, which was in turn significantly related to reduction in percent energy from total fat consumed. Change in percent energy from fat and self-monitoring was associated with 6-month percent change in weight. Both a decrease in fat intake and increase in self-monitoring are potential mediators of the relationship between attendance and weight change., Conclusions: The findings provide a reasonable model that suggests regular session attendance and use of behavioral strategies like self-monitoring are associated with improved behavioral outcomes that are associated with weight loss., (Copyright © 2013 The Obesity Society.)

Background: Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness., Methods: We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months., Results: Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was -3.2 kg (-7.0 lb, P=0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P=0.009). There were no significant between-group differences in adverse events., Conclusions: A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population. (Funded by the National Institute of Mental Health; ACHIEVE ClinicalTrials.gov number, NCT00902694.).

Background: Dietary components effective in weight maintenance efforts have not been adequately identified., Objective: To determine the effects of changes in dietary consumption on weight loss and maintenance during the Weight Loss Maintenance clinical trial., Design: Weight Loss Maintenance was a randomized controlled trial. Successful weight loss participants who completed Phase I of the trial and lost 4 kg were randomized to one of three maintenance intervention arms in Phase II and followed for an additional 30 months., Participants/setting: The multicenter trial was conducted from 2003 through 2007. This substudy included 828 successful weight loss participants., Methods: The Block Food Frequency Questionnaire (FFQ) was used to assess nutrient intake levels and food group servings. Carbohydrates, proteins, fats, dietary fiber, fruit/vegetable, and dairy servings were utilized as predictor variables. The FFQ was collected on all participants at study entry (beginning of Phase I). Those randomized to Phase II completed the FFQ at three additional time points: randomization (beginning of Phase II), 12 months, and 30 months., Intervention: The main intervention focused on long-term maintenance of weight loss using the Dietary Approaches to Hypertension diet. This substudy examined if changes to specific dietary variables were associated with weight loss and maintenance., Statistical Analyses Performed: Linear regression models that adjusted for change in total energy examined the relationship between changes in dietary intake and weight for each time period. Site, age, race, sex, and a race-sex interaction were included as covariates., Results: Participants who substituted protein for fat lost, on average, 0.33 kg per 6 months during Phase I (P<0.0001) and 0.07 kg per 6 months during Phase II (P<0.0001) per 1% increase in protein. Increased intake of fruits and vegetables was associated with weight loss in Phases I and II: 0.29 kg per 6 months (P<0.0001) and 0.04 kg per 6 months (P=0.0062), respectively, per 1-serving increase. Substitution of carbohydrates for fat and protein for carbohydrates were associated with weight loss during both phases. Increasing dairy intake was associated with significant weight loss during Phase II (-0.17 kg per 6 months per 1-serving increase, P=0.0002), but not during Phase I. Dietary fiber revealed no significant findings., Conclusions: Increasing fruits, vegetables, and low-fat dairy may help achieve weight loss and maintenance., (Copyright © 2011 American Dietetic Association. Published by Elsevier Inc. All rights reserved.)

Background: Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse., Methods: We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. Participants were recruited from six primary care practices; 63.6% were women, 41.0% were black, and the mean age was 54.0 years. One intervention provided patients with weight-loss support remotely--through the telephone, a study-specific Web site, and e-mail. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. There was also a control group in which weight loss was self-directed. Outcomes were compared between each intervention group and the control group and between the two intervention groups. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The trial duration was 24 months., Results: At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) for all participants was 36.6, and the mean weight was 103.8 kg. At 24 months, the mean change in weight from baseline was -0.8 kg in the control group, -4.6 kg in the group receiving remote support only (P<0.001 for the comparison with the control group), and -5.1 kg in the group receiving in-person support (P<0.001 for the comparison with the control group). The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and 41.4% in the group receiving in-person support. The change in weight from baseline did not differ significantly between the two intervention groups., Conclusions: In two behavioral interventions, one delivered with in-person support and the other delivered remotely, without face-to-face contact between participants and weight-loss coaches, obese patients achieved and sustained clinically significant weight loss over a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00783315.).

Objective: Suboptimal diet may be related to the high prevalence of obesity and cardiovascular disease (CVD) in persons with serious mental illnesses, but few studies have characterized dietary intake in this population., Methods: Participants were 102 overweight/obese adults with serious mental illnesses who were being screened for a weight loss trial in psychiatric rehabilitation centers. Direct observation of participant meals was completed using a standardized measurement form., Results: CVD risk factors were common: mean body mass index was 35.7 kg/m2; 30% had diabetes. Participants consumed 100% of caloric beverages served (7.2 oz/meal) but consumption was significantly less than served for fruits (difference of 0.12 cups/meal, p=0.003) and vegetables (0.14 cups/meal, p=0.021). The majority (56%) of meat consumed was high fat., Conclusions and Implications for Practice: Interventions designed to improve dietary intake of persons with serious mental illnesses are needed to improve health in this population at high risk for CVD.

Background: Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE). The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group., Methods/design: A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2) will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months., Discussion: Evidence-based approaches to the high burden of obesity and cardiovascular disease risk in person with serious mental illness are urgently needed. The ACHIEVE Trial is tailored to persons with serious mental illness in community settings. This multi-site randomized clinical trial will provide a rigorous evaluation of a practical behavioral intervention designed to accomplish and sustain weight loss in persons with serious mental illness.

Background: The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions, a personal contact arm and an Internet arm, with a no-treatment control after an initial six-month Phase I weight loss program. The Internet arm focused on use of an interactive website for support of long-term weight maintenance. There is limited information about patterns of website use and specific components of an interactive website that might help promote maintenance of weight loss., Objective: This paper presents a secondary analysis of the subset of participants in the Internet arm and focuses on website use patterns and features associated with long-term weight maintenance., Methods: Adults at risk for cardiovascular disease (CVD) who lost at least 4 kilograms in an initial 20-week group-based, behavioral weight-loss program were trained to use an interactive website for weight loss maintenance. Of the 348 participants, 37% were male and 38% were African American. Mean weight loss was 8.6 kilograms. Participants were encouraged to log in at least weekly and enter a current weight for the 30-month study period. The website contained features that encouraged setting short-term goals, creating action plans, and reinforcing self-management habits. The website also included motivational modules, daily tips, and tailored messages. Based on log-in and weight-entry frequency, we divided participants into three website use categories: consistent, some, and minimal., Results: Participants in the consistent user group (n = 212) were more likely to be older (P = .002), other than African American (P = .02), and more educated (P = .01). While there was no significant difference between website use categories in the amount of Phase I change in body weight (P = .45) or income (P = .78), minimal website users (n = 75) were significantly more likely to have attended fewer Phase I sessions (P = .001) and had a higher initial body mass index (BMI) (P < .001). After adjusting for baseline characteristics including initial BMI, variables most associated with less weight regain included: number of log-ins (P = .001), minutes on the website (P < .001), number of weight entries (P = .002), number of exercise entries (P < .001), and sessions with additional use of website features after weight entry (P = .002)., Conclusion: Participants defined as consistent website users of an interactive behavioral website designed to promote maintenance of weight loss were more successful at maintaining long-term weight loss., Trial Registration: NCT00054925; http://clinicaltrials.gov/ct2/show/NCT00054925 (Archived by WebCite at http://www.webcitation.org/5rC7523ue).

Background: To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I)., Methods: Eligible adults were aged > or =25, overweight or obese (BMI=25-45 kg/m2), and on medications for hypertension and/or dyslipidemia. Anthropomorphic, demographic, and psychosocial measures were collected at baseline and 6 months. Participants (n=1685) attended 20 weekly group sessions to encourage calorie restriction, moderate-intensity physical activity, and the DASH (dietary approaches to stop hypertension) dietary pattern. Weight-loss predictors with missing data were replaced by multiple imputation., Results: Participants were 44% African American and 67% women; 79% were obese (BMI> or =30), 87% were taking anti-hypertensive medications, and 38% were taking antidyslipidemia medications. Participants attended an average of 72% of 20 group sessions. They self-reported 117 minutes of moderate-intensity physical activity per week, kept 3.7 daily food records per week, and consumed 2.9 servings of fruits and vegetables per day. The Phase-I follow-up rate was 92%. Mean (SD) weight change was -5.8 kg (4.4), and 69% lost at least 4 kg. All race-gender subgroups lost substantial weight: African-American men (-5.4 kg +/- 7.7); African-American women (-4.1 kg +/- 2.9); non-African-American men (-8.5 kg +/- 12.9); and non-African-American women (-5.8 kg +/- 6.1). Behavioral measures (e.g., diet records and physical activity) accounted for most of the weight-loss variation, although the association between behavioral measures and weight loss differed by race and gender groups., Conclusions: The WLM behavioral intervention successfully achieved clinically significant short-term weight loss in a diverse population of high-risk patients.

Objective: This study investigates predictors of weight loss among individuals with serious mental illness participating in an 18-month behavioral weight loss intervention, using Lasso regression to select the most powerful predictors. Methods: Data were analyzed from the intervention group of the ACHIEVE trial, an 18-month behavioral weight loss intervention in adults with serious mental illness. Lasso regression was employed to identify predictors of at least five-pound weight loss across the intervention time span. Once predictors were identified, classification trees were created to show examples of how to classify participants into having likely outcomes based on characteristics at baseline and during the intervention. Results: The analyzed sample contained 137 participants. Seventy-one (51.8%) individuals had a net weight loss of at least five pounds from baseline to 18 months. The Lasso regression selected weight loss from baseline to 6 months as a primary predictor of at least five pound 18-month weight loss, with a standardized coefficient of 0.51 (95% CI: −0.37, 1.40). Three other variables were also selected in the regression but added minimal predictive ability. Conclusions: The analyses in this paper demonstrate the importance of tracking weight loss incrementally during an intervention as an indicator for overall weight loss, as well as the challenges in predicting long-term weight loss with other variables commonly available in clinical trials. The methods used in this paper also exemplify how to effectively analyze a clinical trial dataset containing many variables and identify factors related to desired outcomes. [ABSTRACT FROM AUTHOR]

Obesity presents an important public health problem that affects more than a third of the U.S. adult population and that is associated with increased morbidity, mortality, and costs. Previously, we documented that two primary care-based weight loss interventions were clinically effective. To encourage the implementation of and reimbursement for these interventions, we evaluated their relative cost-effectiveness. We performed a cost analysis of the Practice-based Opportunities for Weight Reduction (POWER) trial, a three-arm trial that enrolled 415 patients with obesity from six primary care practices. Trial participants were randomized to a control arm, an in-person support intervention, or a remote support intervention; in the two intervention arms, behavioral interventions were delivered over 24 months, in two phases. Weight loss was measured at 6, 12, and 24 months. Using timesheets and empirical data, we evaluated the cost of the in-person and remote support interventions from the perspective of a health care system delivering the interventions. A univariate sensitivity analysis was conducted to evaluate uncertainty around model assumptions. All comparisons were tested using independent t -tests. Cost of the in-person intervention was higher at 6 months ($113 per participant per month and $117 per kg lost) than the remote support intervention ($101 per participant per month and $99 per kg lost; p <.001). Costs were also higher for the in-person support intervention at 24 months ($73 per participant per month and $342 per kg lost) than for the remote support intervention ($53 per participant per month and $275 per kg lost; p <.001). In the sensitivity analyses, cost ranged from $274/kg lost to $456/kg lost for the in-person support intervention and from $218/kg to $367/kg lost for the remote support intervention. A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention. Expanding the scope of reimbursable programs to include other cost-effective interventions could help ensure that a broader range of patients receive the type of support needed. [ABSTRACT FROM AUTHOR]

BACKGROUND: Overweight and obesity are significant concerns for first responders (firefighters and emergency medical service providers). OBJECTIVE: This pilot study examines the feasibility of a weight loss program for career first responders. METHODS: Participants were career first responders with BMI≥30 and interest in losing weight. Baseline height, weight, and body composition using dual x-ray absorptiometry, Pittsburgh Sleep Quality Index (PSQI), and a Functional Movement Screen (FMS) with follow-up weight and body composition were assessed. A 10-week weight loss program used evidence-based lifestyle goals (encouraged increasing activity levels, using tailored calorie goals, following the DASH diet, tracking with a phone app) and weekly in-person sessions with a student coach-in-training who reviewed weight and tracking information. RESULTS: Participants (N = 10) were 39.0±9.9 years old with a BMI of 35.6±4.7 kg/m2. There were significant reductions in weight –4.8±2.3 kg and percent body fat –3.9±1.7%. All participants had a PSQI score >5 indicating poor quality of sleep. Nine participants had FMS scores ≤14 indicating increased risk of injury. CONCLUSION: The use of commercially available apps with support from a student coach-in-training and evidence-based weight loss recommendations is a feasible approach to support career firefighters in their weight loss efforts. [ABSTRACT FROM AUTHOR]

People with serious mental illnesses (SMIs) die 10–20 years earlier than the general population, mainly due to cardiovascular disease. Obesity is a key driver of cardiovascular risk in this group. Because behavioral weight loss interventions tailored to the needs of people with SMI have been shown to lead to clinically significant weight loss, achieving widespread implementation of these interventions is a public health priority. In this Perspective, we consider strategies for scaling the ACHIEVE behavioral weight loss intervention for people with SMI, shown to be effective in a randomized clinical trial (RCT), to mental health programs in the U.S. and internationally. Given the barriers to high-fidelity implementation of the complex, multi-component ACHIEVE intervention in often under-resourced mental health programs, we posit that substantial additional work is needed to realize the full public health potential of this intervention for people with SMI. We discuss considerations for successful "scale-up," or efforts to expand ACHIEVE to similar settings and populations as those included in the RCT, and "scale-out," or efforts to expand the intervention to different mental health program settings/sub-populations with SMI. For both, we focus on considerations related (1) intervention adaptation and (2) implementation strategy development, highlighting four key domains of implementation strategies that we believe need to be developed and tested: staff capacity building, leadership engagement, organizational change, and policy strategies. We conclude with discussion of the types of future research needed to support ACHIEVE scale-up/out, including hybrid trial designs testing the effectiveness of intervention adaptations and/or implementations strategies. [ABSTRACT FROM AUTHOR]

Objective: In the Weight Loss Maintenance (WLM) Trial, a personal contact (PC) intervention sustained greater weight loss relative to a self-directed (SD) group over 30 months. This study investigated the effects of continued intervention over an additional 30 months and overall weight change across the entire WLM Trial.Methods: WLM had 3 phases. Phase 1 was a 6-month weight loss program. In Phase 2, those who lost ≥4 kg were randomized to a 30-month maintenance trial. In Phase 3, PC participants (n = 196, three sites) were re-randomized to no further intervention (PC-Control) or continued intervention (PC-Active) for 30 more months; 218 SD participants were also followed.Results: During Phase 3, weight increased 1.0 kg in PC-Active and 0.5 kg in PC-Control (mean difference 0.6 kg; 95% CI:-1.4 to 2.7; P = 0.54). Mean weight change over the entire study was -3.2 kg in those originally assigned to PC (PC-Combined) and -1.6 kg in SD (mean difference -1.6 kg; 95% CI:-3.0 to -0.1; P = 0.04).Conclusions: After 30 months of the PC maintenance intervention, continuation for another 30 months provided no additional benefit. However, across the entire study, weight loss was slightly greater in those originally assigned to PC. [ABSTRACT FROM AUTHOR]

Abstract: Background: The benefits of regular physical activity are particularly salient to persons with serious mental illness (SMI) who have increased prevalence of obesity, diabetes, and earlier mortality from cardiovascular disease. Methods: The Activating Consumers to Exercise through Peer Support (ACE) trial will examine the effectiveness of peer support on adherence to a 4-month pilot exercise program for adults with SMI. Design, rationale and baseline data are reported. Baseline measures included: graded treadmill test; six-minute walk; height, weight and blood pressure; body composition; fasting blood; and self-reported psychiatric symptoms. Fitness levels were compared with national data and relationships among fitness parameters, psychological factors and cardiovascular disease risk factors were examined. Results: There were 93 participants and 18 peer leaders recruited from community psychiatry programs with an average age of 47 years (SD 10). There were no differences in demographics (76% female, 72% African American) or mental health symptoms between participants and peer leaders. Ninety-five percent of the sample had below average fitness levels for their age and sex with average MET levels of 5.9 (SD 2.2) for participants and 6.2 (SD 2.3) for peer leaders. Fitness evaluated during the treadmill test and the six-minute-walk were associated (r s  = 0.36, p < 0.001). Lower MET levels were associated with a higher BMI (r s  = −0.35, p < 0.001) and percent body fat (r s  = −0.36, p < 0.001). Conclusion: The uniformly low baseline cardiovascular fitness and the association of fitness with BMI and adiposity underscore the importance of suitably tailored programs to increase physical activity among adults with SMI. [Copyright &y& Elsevier]

Summary Prior in‐person behavioural intervention studies have documented differential weight loss between men and women and by race, with Black women receiving the least benefit. Remotely delivered interventions are now commonplace, but few studies have compared outcomes by race‐gender groups and delivery modality. We conducted a secondary analysis of POWER, a randomized trial (NCT00783315) designed to determine the effectiveness of 2 active, lifestyle‐based, weight loss interventions (remote vs. in‐person) compared to a control group. Participants with obesity and at least one cardiovascular disease risk factor (N = 415) were recruited in the Baltimore, MD area. Data from 233 white and 170 Black individuals were used for this analysis. Following an intention‐to‐treat approach, we compared the mean percent weight loss at 24 months by race‐gender subgroups using repeated‐measures, mixed‐effects models. Everyone lost weight in the active interventions however, weight loss differed by race and gender. white and Black men had similar results for both interventions (white: in‐person (−7.6%) remote (−7.4%); Black: in‐person (−4.7%) remote (−4.4%)). In contrast, white women lost more weight with the in‐person intervention (in‐person (−7.2%) compared to the remote (−4.4%)), whereas Black women lost less weight in the in‐person group compared to the remote intervention at 24 months (−2.0% vs. −3.0%, respectively; p for interaction <.001). We found differences between the effectiveness of the 2 weight loss interventions—in‐person or remote—in white and Black women at 24 months. Future studies should consider intervention modality when designing weight loss interventions for women. [ABSTRACT FROM AUTHOR]

Background: Websites and phone apps are increasingly used to track weights during weight loss interventions, yet the longitudinal accuracy of these self-reported weights is uncertain.Objective: Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic. We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5% weight loss when using self-reported compared to clinic weights.Methods: This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction (POWER) trial, a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor. One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions. All intervention participants (n=277) received a digital scale and were asked to track their weight weekly on a study website. Research staff used a standard protocol to measure weight in the clinic. Differences (self-reported weight - clinic weight) indicate if self-report under (-) or over (+) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month (n=225) and 24-month (n=191) clinic visits. The absolute value of the differences (absolute difference) describes the overall accuracy.Results: Underestimation of self-reported weights increased significantly from 6 months (mean -0.5 kg, SD 1.0 kg) to 24 months (mean -1.1 kg, SD 2.0 kg; P=.002). The average absolute difference also increased from 6 months (mean 0.7 kg, SD 0.8 kg) to 24 months (mean 1.3, SD 1.8 kg; P<.001). Participants who achieved the study weight loss goal at 24 months (based on clinic weights) had lower absolute differences (P=.01) compared to those who did not meet this goal. At 24 months, there was 9% misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome. At 24 months, those with self-reported weights (n=191) had three times the weight loss compared to those (n=73) without self-reported weights (P<.001).Conclusions: Underestimation of weight increased over time and was associated with less weight loss. In addition to intervention adherence, weight loss programs should emphasize accuracy in self-reporting.Trial Registration: ClinicalTrials.gov: NCT00783315; http://clinicaltrials.gov/show/NCT00783315 (Archived by WebCite at http://www.webcitation.org/6R4gDAK5K). [ABSTRACT FROM AUTHOR]

Abstract: This study objectively measured physical activity levels in overweight and obese adults with severe mental illness and examined relationships among psychiatric symptoms, cognitive functioning and physical activity. A diverse sample (50% female, 50% African American) of overweight and obese adults (n =55) with mental illness were asked to wear accelerometers for 4 days. Study participants averaged 120 min/week of moderate to vigorous physical activity (MVPA); 35% had ≥150 min/week of MVPA. Only 4% accumulated ≥150 min/week of MVPA in bouts ≥10 min as per public health recommendations. Depressive symptoms, psychological distress and cognitive functioning were not associated with physical activity (p >.05). Although participants appeared to have substantial minutes of MVPA, increased physical activity bouts, or sessions, may be necessary for increased health and weight management benefits for persons with severe mental illness. Efforts are needed to increase physical activity sessions in this vulnerable population. [Copyright &y& Elsevier]

Introduction: Obesity is epidemic among adults with serious mental illness (SMI) (e.g., schizophrenia, bipolar disorder) and evidenced-based weight loss programs are needed for this group. We examined the association between attendance to program sessions and weight change among adults with SMI who were enrolled in a lifestyle-based weight loss trial. Methods: Overweight and obese adults with SMI were randomized to either a control group (n=147) or an active intervention group (n=144) that received weight loss classes (3/month), individual weight management sessions (monthly), and group exercise classes (3/week) during the first 6 months. These classes tapered off during months 7-18. Study staff maintained attendance records. Standardized weight was assessed at baseline, 6 and 18 months. Regression analyses included weight change as the dependent variable and controlled for sex, age, and site. Results: The active intervention group was 51% female with an average age of 47 years. Main results have reported significant weight loss at 6 (M=-1.7kg, SD=4.6) and 18 months (M=-3.4kg, SD=7.4). Attendance at 6 and 18 months are reported in the figure below. Attendance was not associated with weight change at 6 months. Overall percent attendance was not associated with 18 month weight change (B=-0.02, p=-.59). A second regression model included percent attendance individually for each of type of session and group weight loss attendance (B=-0.10, p=.04) was associated with weight loss; however, individual weight loss sessions (B=0.002, p=.95), and group exercise (B=0.08, p=.08) were not associated with weight loss. Conclusion: Although overall attendance was not associated with weight loss, attendance to the group weight loss session was associated with weight loss at 18 months. It is not clear if the content of the weight loss groups was particularly effective or if adherence to these sessions was the strongest indicator of adherence to the behavioral recommendations. [ABSTRACT FROM AUTHOR]

To compare the effect of Healthy for Two/Healthy for You (H42/H4U), a health coaching program, in prenatal care clinics that serve a racially and economically diverse population, on total gestational weight gain (GWG) (vs. usual care). We hypothesize that compared to usual prenatal care, intervention participants will have lower GWG and lower rates of gestational diabetes mellitus (GDM). We report the rationale and design of a pragmatic, parallel arm randomized clinical trial with 380 pregnant patients ≤15 weeks gestation with overweight or obesity from one of 6 academic and community-based obstetrics practices, randomized to either H42/H4U or usual prenatal care in a 1:1 ratio. The study duration is early pregnancy to 6 months postpartum. The primary outcome is total GWG, calculated as the difference between first clinic-assessed pregnancy weight and the weight at 37 weeks gestation. Key maternal and infant secondary outcomes include GDM incidence, weight retention at 6 months postpartum, infant weight, maternal health behaviors and wellness. This pragmatic clinical trial embeds a pregnancy health coaching program into prenatal care to allow parallel testing compared to usual prenatal care on the outcome of total GWG. The real-world design provides an approach to enhance its sustainability beyond the trial to ultimately improve maternal/child health outcomes and reduce future obesity. The study was first registered at clinicaltrials.gov on 1/26/21 (NCT04724330). [ABSTRACT FROM AUTHOR]