A two-year randomized trial of obesity treatment in primary care practice

BACKGROUND Calls for primary care providers (PCPs) to offer obese patients behavioral weight-loss counseling have not been accompanied by adequate guidance on how such care could be delivered. This randomized trial compared weight loss during a 2-year period in response to three lifestyle interventions, all delivered by PCPs in collaboration with auxiliary health professionals (lifestyle coaches) in their practices. METHODS We randomly assigned 390 obese adults in six primary care practices to one of three types of intervention: usual care, consisting of quarterly PCP visits that included education about weight management; brief lifestyle counseling, consisting of quarterly PCP visits combined with brief monthly sessions with lifestyle coaches who instructed participants about behavioral weight control; or enhanced brief lifestyle counseling, which provided the same care as described for the previous intervention but included meal replacements or weight-loss medication (orlistat or sibutramine), chosen by the participants in consultation with the PCPs, to potentially increase weight loss. RESULTS Of the 390 participants, 86% completed the 2-year trial, at which time, the mean (±SE) weight loss with usual care, brief lifestyle counseling, and enhanced brief lifestyle counseling was 1.7±0.7, 2.9±0.7, and 4.6±0.7 kg, respectively. Initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of the participants in the three groups, respectively. Enhanced lifestyle counseling was superior to usual care on both these measures of success (P=0.003 and P=0.02, respectively), with no other significant differences among the groups. The benefits of enhanced lifestyle counseling remained even after participants given sibutramine were excluded from the analyses. There were no significant differences between the intervention groups in the occurrence of serious adverse events

Treatment of Comorbid Obesity and Major Depressive Disorder: A Prospective Pilot Study for their Combined Treatment

Background. Obese individuals who suffer from major depressive disorder are routinely screened out of weight loss trials. Treatments targeting obesity and depression concurrently have not been tested. Purpose. To test the short-term efficacy of a treatment that combined behavioral weight management and cognitive behavioral therapy (CBT) for obese adults with depression. Methods. Twelve obese females diagnosed with major depressive disorder received weekly group behavioral weight management, combined with CBT for depression, for 16 weeks. Weight, symptoms of depression, and cardiovascular disease (CVD) risk factors were measured at baseline and week 16. Results. Participants lost 11.4% of initial weight and achieved significant improvements in symptoms of depression and CVD risk factors. Conclusions. Obese individuals suffering from major depressive disorder can lose weight and achieve improvements in symptoms of depression and CVD risk factors with 16 weeks of combined treatment. A larger randomized controlled trial is needed to establish the efficacy of this treatment

Maintenance of Weight Loss in Adolescents: Current Status and Future Directions

There is a dearth of research on the long-term efficacy and safety of treatments for adolescent obesity. This narrative review examined several approaches to treatment, focusing on long-term effectiveness data in adolescents, as well as relevant findings from studies of adults. The available research suggests that lifestyle modification has promise in obese adolescents, although it is not clear that any particular dietary or physical activity approach is more effective than another. Meal replacements are quite effective in adults and deserve further research in adolescents. Extending the length of treatment to teach weight loss maintenance skills is likely to improve long-term outcomes in adolescents, and delivering treatment via the Internet or telephone is a novel way of doing so. Treatment that combines lifestyle modification with the medication orlistat generally appears to be safe but only marginally superior to lifestyle modification alone. More research is needed on the management of adolescent obesity, which has been overlooked when compared with research on the treatment of obesity in children and adults

Weight Bias Internalization Is Negatively Associated With Weight-Related Quality of Life in Persons Seeking Weight Loss

Research has shown a negative relationship between weight bias internalization (WBI) and general measures of health-related quality of life (QOL), such as the Short Form–36. Less is known about the impact of WBI on weight-specific domains of QOL. This study examined the relationship between WBI and weight-related QOL, as measured by the Impact of Weight on Quality of Life (IWQOL-Lite) scale. Participants were 178 adults with obesity [71.3% black, 87.6% female, mean body mass index (BMI) = 40.9 ± 5.9 kg/m2] enrolled in a weight loss trial testing the effects of lorcaserin on weight loss maintenance. At baseline, participants completed the Weight Bias Internalization Scale (WBIS), the IWQOL-Lite and the Patient Health Questionnaire (PHQ-9, to assess symptoms of depression). Total scores for the IWQOL-Lite and its five subscales (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) were calculated. Linear regression analyses showed that WBIS scores were associated with the IWQOL-Lite total score and all subscales above and beyond the effects of demographic variables, BMI, and depressive symptoms (beta values = -0.18 to -0.70, p values < 0.019). The relationship between WBIS and the IWQOL-Lite scales did not differ by gender or race. WBI was associated with mental and physical aspects of weight-related QOL in a predominantly black and female treatment-seeking sample of patients with obesity. Prioritizing the development of interventions to reduce WBI may be important for improving weight-related QOL

CPAP, weight loss, or both for obstructive sleep apnea

BACKGROUNd: Obesity and obstructive sleep apnea tend to coexist and are associated with inflammation, insulin resistance, dyslipidemia, and high blood pressure, but their causal relation to these abnormalities is unclear. METHODS: We randomly assigned 181 patients with obesity, moderate-to-severe obstructive sleep apnea, and serum levels of C-reactive protein (CRP) greater than 1.0 mg per liter to receive treatment with continuous positive airway pressure (CPAP), a weight-loss intervention, or CPAP plus a weight-loss intervention for 24 weeks. We assessed the incremental effect of the combined interventions over each one alone on the CRP level (the primary end point), insulin sensitivity, lipid levels, and blood pressure. RESULTS: Among the 146 participants for whom there were follow-up data, those assigned to weight loss only and those assigned to the combined interventions had reductions in CRP levels, insulin resistance, and serum triglyceride levels. None of these changes were observed in the group receiving CPAP alone. Blood pressure was reduced in all three groups. No significant incremental effect on CRP levels was found for the combined interventions as compared with either weight loss or CPAP alone. Reductions in insulin resistance and serum triglyceride levels were greater in the combined-intervention group than in the group receiving CPAP only, but there were no significant differences in these values between the combined-intervention group and the weight-loss group. In per-protocol analyses, which included 90 participants who met prespecified criteria for adherence, the combined interventions resulted in a larger reduction in systolic blood pressure and mean arterial pressure than did either CPAP or weight loss alone. CONCLUSIONS: In adults with obesity and obstructive sleep apnea, CPAP combined with a weight-loss intervention did not reduce CRP levels more than either intervention alone. In secondary analyses, weight loss provided an incremental reduction in insulin resistance and serum triglyceride levels when combined with CPAP. In addition, adherence to a regimen of weight loss and CPAP may result in incremental reductions in blood pressure as compared with either intervention alone. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT0371293 .)

Estimating and reporting treatment effects in clinical trials for weight management: using estimands to interpret effects of intercurrent events and missing data

In the approval process for new weight management therapies, regulators typically require estimates of effect size. Usually, as with other drug evaluations, the placebo-adjusted treatment effect (i.e., the difference between weight losses with pharmacotherapy and placebo, when given as an adjunct to lifestyle intervention) is provided from data in randomized clinical trials (RCTs). At first glance, this may seem appropriate and straightforward. However, weight loss is not a simple direct drug effect, but is also mediated by other factors such as changes in diet and physical activity. Interpreting observed differences between treatment arms in weight management RCTs can be challenging; intercurrent events that occur after treatment initiation may affect the interpretation of results at the end of treatment. Utilizing estimands helps to address these uncertainties and improve transparency in clinical trial reporting by better matching the treatment-effect estimates to the scientific and/or clinical questions of interest. Estimands aim to provide an indication of trial outcomes that might be expected in the same patients under different conditions. This article reviews how intercurrent events during weight management trials can influence placebo-adjusted treatment effects, depending on how they are accounted for and how missing data are handled. The most appropriate method for statistical analysis is also discussed, including assessment of the last observation carried forward approach, and more recent methods, such as multiple imputation and mixed models for repeated measures. The use of each of these approaches, and that of estimands, is discussed in the context of the SCALE phase 3a and 3b RCTs evaluating the effect of liraglutide 3.0 mg for the treatment of obesity

Do Health Beliefs and Behaviors Differ According to Severity of Obesity? A Qualitative Study of Australian Adults

Public responses to obesity have focused on providing standardized messages and supports to all obese individuals, but there is limited understanding of the impact of these messages on obese adults. This descriptive qualitative study using in-depth interviews and a thematic method of analysis, compares the health beliefs and behaviors of 141 Australian adults with mild to moderate (BMI 30−39.9) and severe (BMI ≥ 40) obesity. Mildly obese individuals felt little need to change their health behaviors or to lose weight for health reasons. Most believed they could “lose weight” if they needed to, distanced themselves from the word obesity, and stigmatized those “fatter” than themselves. Severely obese individuals felt an urgent need to change their health behaviors, but felt powerless to do so. They blamed themselves for their weight, used stereotypical language to describe their health behaviors, and described being “at war” with their bodies. Further research, particularly about the role of stigma and stereotyping, is needed to fully understand the impact of obesity messaging on the health beliefs, behaviors, and wellbeing of obese and severely obese adults