A Behavioral Weight-Loss Intervention in Persons with Serious Mental Illness

Long-term effectiveness of lifestyle and behavioral weight loss interventions in adults with type 2 diabetes: A meta-analysis

Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse. 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. 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. 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.).

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. 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. 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). A behavioral weight loss intervention is effective among overweight and obese individuals with SMI regardless of their diabetes status.

Fitness Regimen Helps Seriously Mentally Ill People Lose Weight

ObjectiveOverweight and obesity are epidemic in populations with serious mental illnesses. We developed and pilot tested a behavioral weight loss intervention appropriately tailored for persons with serious mental disorders.MethodsWe conducted a single arm pilot study in two psychiatric rehabilitation day programs in Maryland and enrolled 63 overweight or obese adults. The six-month intervention provided group and individual weight management and group physical activity classes. The primary outcome was weight change from baseline to 6 months.ResultsSixty-four percent of those potentially eligible at the centers enrolled. The mean age was 43.7 years; 56% were women, 49% were white and over half had a schizophrenia or schizoaffective disorder. One third had hypertension and one fifth had diabetes. Fifty-two (82%) completed the study; others were discharged from psychiatric centers before study completion. Average attendance across all weight management sessions was 70% (87% on days participants attended the center) and 59% for physical activity classes (74% on days participants attended the center). From a baseline mean of 210.9 lbs (SD 43.9), average weight loss for 52 participants was 4.5 pounds (SD 12.8) (p<0.014). On average, participants lost 1.9% of body weight. Mean waist circumference change was 3.1 cm (SD 5.6). Participants on average increased the distance on the six minute walk test by eight percent.ConclusionThis pilot documents the feasibility and preliminary efficacy of a behavioral weight loss intervention in adults with serious mental illness who were attendees at psychiatric rehabilitation centers. The results may have implications for developing weight loss interventions in other institutional settings such as schools or nursing homes.

Most persons with type 2 diabetes are overweight and obesity worsens the metabolic and physiologic abnormalities associated with diabetes. The objective of this review is to assess the effectiveness of lifestyle and behavioral weight loss and weight control interventions for adults with type 2 diabetes. Studies were obtained from computerized searches of multiple electronic bibliographic databases, supplemented with hand searches of selected journals and consultation with experts in obesity research. The last search was conducted May, 2004. Studies were included if they were published or unpublished randomized controlled trials in any language, and examined weight loss or weight control strategies using one or more dietary, physical activity, or behavioral interventions, with a follow-up interval of at least 12 months. Effects were combined using a random effects model. The 22 studies of weight loss interventions identified had a 4,659 participants and follow-up of 1 to 5 years. The pooled weight loss for any intervention in comparison to usual care among 585 subjects was 1.7 kg (95 % confidence interval [CI] 0.3 to 3.2), or 3.1% of baseline body weight among 517 subjects. Other main comparisons demonstrated nonsignificant results: among 126 persons receiving a physical activity and behavioral intervention, those who also received a very low calorie diet lost 3.0 kg (95% CI -0.5 to 6.4), or 1.6% of baseline body weight, more than persons receiving a low-calorie diet. Among 53 persons receiving identical dietary and behavioral interventions, those receiving more intense physical activity interventions lost 3.9 kg (95% CI -1.9 to 9.7), or 3.6% of baseline body weight, more than those receiving a less intense or no physical activity intervention. Comparison groups often achieved significant weight loss (up to 10.0 kg), minimizing between-group differences. Changes in glycated hemoglobin generally corresponded to changes in weight and were not significant when between-group differences were examined. No data were identified on quality of life and mortality. Weight loss strategies using dietary, physical activity, or behavioral interventions produced small between-group improvements in weight. These results were minimized by weight loss in the comparison group, however, and examination of individual study arms revealed that multicomponent interventions including very low calorie diets or low calorie diets may hold promise for achieving weight loss in adults with type 2 diabetes.

Improving Knowledge About Mental Illness Through Family-Led Education: The Journey of Hope

Introduction: Weight loss through behavioural weight management interventions can have important health benefits for people with obesity. However, to maximise the health benefits, weight loss must be maintained. Evidence suggests that behavioural weight loss interventions do not exacerbate inequalities in the short term. However, no study has yet considered whether inequalities exist in long-term weight change following intervention. We aimed to investigate if there are inequalities in weight change following weight loss intervention. Methods: We conducted a cohort analysis of data from the Weight Loss Referrals for Adults in Primary Care (WRAP) trial (N = 1,267). WRAP randomised participants to receive a brief intervention information booklet or vouchers for 12-weeks or 52-weeks of WW (formerly WeightWatchers) and followed them for 5 years. Multiple linear regression estimated the association between exposures (indicators of inequality) and outcomes (change in weight between 1- and 5-years). Each model was adjusted for the intervention group, baseline weight, weight change between baseline and 1-year, research centre, and source of the 5-year weight data. Results: Of the 1,267 participants in WRAP, 708 had weight change data available. Mean weight change between 1- and 5-years was +3.30 kg (SD 9.10 kg). A 1 year difference in age at baseline was associated with weight change of 0.11 kg ((95% CI 0.06, 0.16), p < 0.001). We did not find evidence of associations between ethnicity, gender, education, indices of multiple deprivation, household income, or other family members participating in a weight loss programme and weight change. Conclusion: Except for age, we did not find evidence of inequalities in weight change following a behavioural intervention. Findings further support the use of behavioural weight management interventions as part of a systems-wide approach to improving population health.

Sustained Weight Loss and Improvements in Cardiometabolic Risk Factors in a Worksite-based Behavioral Program (FS18-04-19)

To test the hypothesis that a screening and treatment intervention for early cryptococcal infection would improve survival among HIV-infected individuals with low CD4 cell counts. Newly enrolled patients at Family AIDS Care and Education Services (FACES) in Kenya with CD4≤100 cells/μl were tested for serum cryptococcal antigen (sCrAg). Individuals with sCrAg titre≥1:2 were treated with high-dose fluconazole. Cox proportional hazard models of Kaplan-Meier curves were used to compare survival among individuals with CD4≤100 cells/μl in the intervention and historical control groups. The median age was 34years [IQR: 29,41], 54% were female, and median CD4 was 43 cells/μl [IQR: 18,71]. Follow-up time was 1224 person-years. In the intervention group, 66% (514/782) were tested for sCrAg; of whom, 11% (59/514) were sCrAg positive. Mortality was 25% (196/782) in the intervention group and 25% (191/771) in the control group. There was no significant difference between the intervention and control group in overall survival [hazard ratio (HR): 1.1 (95%CI:0.9,1.3)] or three-month survival [HR: 1.0 (95%CI:0.8,1.3)]. Within the intervention group, sCrAg-positive individuals had significantly lower survival rates than sCrAg-negative individuals [HR:1.8 (95%CI: 1.0, 3.0)]. A screening and treatment intervention to identify sCrAg-positive individuals and treat them with high-dose fluconazole did not significantly improve overall survival among HIV-infected individuals with CD4 counts≤100 cells/μl compared to a historical control, perhaps due to intervention uptake rates or poor efficacy of high-dose oral fluconazole.

Behavioral weight loss interventions can lead to an average weight loss of 5%-10% of initial body weight, however there is wide individual variability in treatment response. Although built, social, and community food environments can have potential direct and indirect influences on body weight (through their influence on physical activity and energy intake), these environmental factors are rarely considered as predictors of variation in weight loss. Evaluate the association between built, social, and community food environments and changes in weight, moderate-to-vigorous physical activity (MVPA), and dietary intake among adults who completed an 18-month behavioral weight loss intervention. Participants included 93 adults (mean±SD; 41.5±8.3years, 34.4±4.2kg/m2, 82% female, 75% white). Environmental variables included urbanicity, walkability, crime, Neighborhood Deprivation Index (includes 13 social economic status factors), and density of convenience stores, grocery stores, and limited-service restaurants at the tract level. Linear regressions examined associations between environment and changes in body weight, waist circumference (WC), MVPA (SenseWear device), and dietary intake (3-day diet records) from baseline to 18months. Grocery store density was inversely associated with change in weight (β=-0.95; p=0.02; R 2=0.062) and WC (β=-1.23; p<0.01; R 2=0.109). Participants living in tracts with lower walkability demonstrated lower baseline MVPA and greater increases in MVPA versus participants with higher walkability (interaction p=0.03). Participants living in tracts with the most deprivation demonstrated greater increases in average daily steps (β=2048.27; p=0.02; R 2=0.039) versus participants with the least deprivation. Limited-service restaurant density was associated with change in % protein intake (β=0.39; p=0.046; R 2=0.051). Environmental factors accounted for some of the variability (<11%) in response to a behavioral weight loss intervention. Grocery store density was positively associated with weight loss at 18months. Additional studies and/or pooled analyses, encompassing greater environmental variation, are required to further evaluate whether environment contributes to weight loss variability.

Personalized interventions that leverage workplace data and environments could improve effectiveness, sustainability, and scalability of employee wellness programs. To test an automated behavioral intervention to prevent weight gain and improve diet using employee cafeteria purchasing data. This individual-level randomized clinical trial of a 12-month intervention with 12 months of follow-up was conducted among employees of a hospital in Boston, Massachusetts, who purchased food at on-site cafeterias that used traffic-light labels (ie, green indicates healthy; yellow, less healthy; red, unhealthy). Participants were enrolled September 2016 to February 2018. Data were analyzed from May to September 2020. For 12 months, participants in the intervention group received 2 emails per week with feedback on previous cafeteria purchases and personalized health and lifestyle tips and 1 letter per month with peer comparisons and financial incentives for healthier purchases. Emails and letters were automatically generated using survey, health, and cafeteria data. Control group participants received 1 letter per month with general healthy lifestyle information. The main outcome was change in weight from baseline to 12 months and 24 months of follow-up. Secondary outcomes included changes in cafeteria purchases, including proportion of green- and red-labeled purchases and calories purchased per day, from baseline (12 months preintervention) to the intervention (months 1-12) and follow-up (months 13-24) periods. Baseline Healthy Eating Index-15 (HEI-15) scores were compared to HEI-15 scores at 6, 12, and 24 months. Among 602 employees enrolled (mean [SD] age, 43.6 [12.2] years; 478 [79.4%] women), 299 were randomized to the intervention group and 303 were randomized to the control group. Baseline mean (SD) body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) was 28.3 (6.6) and HEI-15 score was 60.4 (12.4). There were no between-group differences in weight change at 12 (0.2 [95% CI, -0.6 to 1.0] kg) or 24 (0.6 [95% CI, -0.3 to 1.4] kg) months. Compared with baseline, the intervention group increased green-labeled purchases by 7.3% (95% CI, 5.4% to 9.3%) and decreased red-labeled purchases by 3.9% (95% CI, -5.0% to -2.7%) and calories purchased per day by 49.5 (95% CI, -75.2 to -23.9) kcal more than the control group during the intervention period. In the intervention group, differences in changes in green (4.8% [95% CI, 2.9% to 6.8%]) and red purchases (-3.1% [95% CI, -4.3% to -2.0%]) were sustained at the 24-month follow-up. Differences in changes in HEI-15 scores were not significantly different in the intervention compared with the control group at 6 (2.2 [95% CI, 0 to 4.4]), 12 (1.8 [95% CI, -0.6 to 4.1]), and 24 (1.6, 95% CI, -0.7 to 3.8]) months. The findings of this randomized clinical trial suggest that an automated behavioral intervention using workplace cafeteria data improved employees' food choices but did not prevent weight gain over 2 years. ClinicalTrials.gov Identifier: NCT02660086.

Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date. In this multicenter trial, 692 overweight/obese women who were, on average, 2 years since primary treatment for early-stage breast cancer were randomly assigned to either a group-based behavioral intervention, supplemented with telephone counseling and tailored newsletters, to support weight loss or a less intensive control intervention and observed for 2 years. Weight and blood pressure were measured at 6, 12, 18, and 24 months. Longitudinal mixed models were used to analyze change over time. At 12 months, mean weight loss was 6.0% of initial weight in the intervention group and 1.5% in the control group (P<.001). At 24 months, mean weight loss in the intervention and control groups was 3.7% and 1.3%, respectively (P<.001). Favorable effects of the intervention on physical activity and blood pressure were observed. The weight loss intervention was more effective among women older than 55 years than among younger women. A behavioral weight loss intervention can lead to clinically meaningful weight loss in overweight/obese survivors of breast cancer. These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival.

Obesity is a strong risk factor for urinary incontinence. Although marked weight loss after bariatric surgery in morbidly obese women was associated in previous studies with a reduction in urinary incontinence, the overall evidence for a benefit of weight loss in obese women is inconclusive. In this randomized clinical trial, the Program to Reduce Incontinence by Diet and Exercise, the potential benefits of a behavioral weight-reduction intervention were compared with a structured educational program in 338 overweight and obese women with at least 10 urinary incontinence episodes per week. The study subjects were randomized to receive either an intensive 6-month weight-loss program that included diet, exercise, and behavior modification (intervention group, n = 226) or a structured education program consisting of general information about healthy eating, physical activity, and weight loss (control group, n = 112). The mean (±SD) age of the study subjects was 53 ± 11 years. Body-mass index (BMI) was calculated as the weight in kilograms divided by the square of the height in meters. The primary study outcome was the change in the total number of self-reported incontinence episodes of any type (including stress and urge incontinence) recorded in a 7-day voiding diary at 6 months after randomization. At baseline, the mean BMI and the total number of incontinence episodes per week were the same in the intervention and control groups (BMI, 36 ± 6 vs. 36 ± 5, respectively; incontinence episodes, 24 ± 18 vs. 24 ± 16, respectively). At 6 months, the mean weight loss among women in the intervention group was 8.0% (7.8 kg), whereas the mean weight loss among women in the control group was 1.6% (1.5 kg) (P < .001). There was a greater decrease in total number of incontinence episodes per week in the intervention group at 6 months compared with the control group (intervention: 47.4% vs. control: 28.1%, P = 0.01). The frequency of stress incontinence episodes was reduced more in the intervention group (57.6%) than the control group (32.7%, P = 0.02). The frequency of episodes of urge incontinence was also decreased more in the intervention group (42.4% vs. 26.0%), but the difference was not statistically significant (P = 0.14). In comparison with the control group, a higher proportion of women in the intervention group reported a clinically meaningful reduction of at least 70% in the total weekly number of episodes of any type of incontinence (P < 0.001), stress-incontinence (P = 0.009), and urge-incontinence (P = 0.04). The investigators conclude from these findings that weight loss should be considered as a first-line treatment in overweight and obese women with incontinence.

BackgroundOverweight 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/DesignA 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.DiscussionEvidence-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.Trial RegistrationClinical Trials.gov NCT00902694