Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.

Importance: Obesity is associated with numerous psychosocial complications, making psychiatric safety a consideration for treating people with obesity. Few studies have investigated the psychiatric safety of newly available antiobesity medications. Objective: To evaluate the psychiatric safety of subcutaneous semaglutide, 2.4 mg, once weekly in people without known major psychopathology. Design, Setting, and Participants: This post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes. Trial designs have been published previously. Interventions: Semaglutide, 2.4 mg, vs placebo. Main Outcomes and Measures: Depressive symptoms and suicidal ideation/behavior were assessed using the Patient Health Questionnaire (PHQ-9) and Columbia-Suicide Severity Rating Scale, respectively. Psychiatric and nervous system disorder adverse events were investigated. Results: This analysis included 3377 participants in the STEP 1, 2, and 3 trials (2360 women [69.6%]; mean [SD] age, 49 [13] years) and 304 participants in STEP 5 (236 women [77.6%]; mean [SD] age, 47 [11] years). In the STEP 1, 2, and 3 trials, mean (SD) baseline PHQ-9 scores for the semaglutide, 2.4 mg, and placebo groups were 2.0 (2.3) and 1.8 (2.3), respectively, indicating no/minimal symptoms of depression. PHQ-9 scores at week 68 were 2.0 (2.9) and 2.4 (3.3), respectively; the estimated treatment difference (95% CI) between groups was -0.56 (-0.81 to -0.32) (P < .001). Participants treated with semaglutide vs placebo were less likely to shift (from baseline to week 68) to a more severe category of PHQ-9 depression (odds ratio, 0.63; 95% CI, 0.50-0.79; P < .001). Based on the Columbia-Suicide Severity Rating Scale, 1% or fewer of participants reported suicidal ideation/behavior during treatment, with no differences between semaglutide, 2.4 mg, and placebo. Psychiatric disorder adverse events were generally balanced between groups. Similar results were observed in STEP 5. Conclusions and Relevance: The results of this post hoc analysis suggest that treatment with semaglutide, 2.4 mg, did not increase the risk of developing symptoms of depression or suicidal ideation/behavior vs placebo and was associated with a small but statistically significant reduction in depressive symptoms (not considered clinically meaningful). People with obesity should be monitored for mental health concerns so they can receive appropriate support and care. Trial Registration: ClinicalTrials.gov Identifiers: STEP 1 (NCT03548935), 2 (NCT03552757), 3 (NCT03611582), and 5 (NCT03693430).

Longitudinal associations of internalized weight stigma with physical activity and weight loss.

Objective: Cross-sectional research has demonstrated that internalized weight stigma (IWS) is associated with less engagement in weight management behaviors, including physical activity. However, limited research has explored longitudinal relationships among IWS, physical activity, and weight loss. This study examined longitudinal associations of changes in IWS, physical activity, and weight and tested whether physical activity mediated the relationship between IWS and weight change. Methods: Individuals with obesity and high IWS (N = 105) participated in a 72-week behavioral weight loss intervention, with or without a weight stigma intervention. Measures of IWS (Weight Self-Stigma Questionnaire), physical activity (accelerometry and self-report), and weight were collected at baseline and weeks 20, 46 and 72. Correlations examined relationships among changes in variables from baseline to all timepoints, controlling for treatment condition. Mediation, controlling for treatment condition, tested whether IWS reductions during the first 20 weeks predicted greater weight loss at weeks 46 and 72 via increased physical activity between weeks 20 and 46 or 72. Results: Decreases in IWS at week 20 were associated with greater week-20 weight loss (r = 0.265, p = 0.012). Physical activity was not a significant mediator, but greater reductions in IWS at week 20 predicted greater week-46 weight loss with or without controlling for physical activity (WSSQ: b = 0.30, confidence interval: 0.12, 0.54). Significant associations were not found at week 72. Conclusion: Initial reductions in IWS were associated with greater week-46 weight loss. Further research should investigate whether reducing IWS early in obesity treatment enhances long-term outcomes. Clinical trial registration: ClinicalTrials.gov (NCT03704064).

Neural Responses to Auditory Food Stimuli Following Cognitive Behavioral Therapy for Binge-Eating Disorder.

OBJECTIVE: Adults with binge-eating disorder (BED), compared with those without BED, demonstrate higher blood-oxygen-level-dependent (BOLD) response to food cues in reward-related regions of the brain. It is not known whether cognitive behavioral therapy (CBT) can reverse this reward system hyperactivation. This randomized controlled trial (RCT) assessed changes in BOLD response to binge-eating cues following CBT versus wait-list control (WLC). METHOD: Females with BED (N = 40) were randomized to CBT or WLC. Participants completed assessments at baseline and 16 weeks including measures of eating and appetite and functional magnetic resonance imaging (fMRI) to measure BOLD response while listening to personalized scripts of binge-eating and neutral-relaxing cues. Data were analyzed using general linear models with mixed effects. RESULTS: Overall retention rate was 87.5%. CBT achieved significantly greater reductions in binge-eating episodes than WLC (mean ± standard error decline of 14.6 ± 2.7 vs. 5.7 ± 2.8 episodes in the past 28 days, respectively; p = 0.03). CBT and WLC did not differ significantly in changes in neural responses to binge-eating stimuli during the fMRI sessions. Compared with WLC, CBT had significantly greater improvements in reward-based eating drive, disinhibition, and hunger as assessed by questionnaires (ps < 0.05). DISCUSSION: CBT was effective in reducing binge eating, but, contrary to our hypothesis, CBT did not improve BOLD response to auditory binge-eating stimuli in reward regions of the brain. Further studies are needed to assess mechanisms underlying improvements with CBT for BED. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03604172.

Nutritional considerations with antiobesity medications.

The improved efficacy and generally favorable safety profile of recently approved and emerging antiobesity medications (AOMs), which result in an average weight reduction of ≥15%, represent significant advancement in the treatment of obesity. This narrative review aims to provide practical evidence-based recommendations for nutritional assessment, management, and monitoring of patients treated with AOMs. Prior to treatment, clinicians can identify preexisting nutritional risk factors and counsel their patients on recommended intakes of protein, dietary fiber, micronutrients, and fluids. During treatment with AOMs, ongoing monitoring can facilitate early recognition and management of gastrointestinal symptoms or inadequate nutrient or fluid intake. Attention should also be paid to other factors that can impact response to treatment and quality of life, such as physical activity and social and emotional health. In the context of treatment with AOMs, clinicians can play an active role in supporting their patients with obesity to improve their health and well-being and promote optimal nutritional and medical outcomes.

Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials.

AIMS: To summarize the effects of semaglutide 2.4 mg on weight-related quality of life (WRQOL) and health-related quality of life (HRQOL), focusing on the confirmatory secondary endpoint of physical functioning. MATERIALS AND METHODS: The STEP 1-4 Phase 3a, 68-week, double-blind, randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with overweight/obesity. WRQOL and HRQOL were assessed by change from baseline to Week 68 in two different but complementary measures, the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT; STEP 1 and 2) and the SF-36v2 Health Survey Acute (SF-36v2; STEP 1-4). RESULTS: Superiority for semaglutide 2.4 mg over placebo based on IWQOL-Lite-CT and SF-36v2 physical functioning scores was confirmed in STEP 1 and 2 and in STEP 1, 2 and 4, respectively. At Week 68, a greater proportion of participants treated with semaglutide 2.4 mg than with placebo reached meaningful within-person change (MWPC) thresholds for IWQOL-Lite-CT Physical Function scores in STEP 1 (51.8% vs. 28.3%; p < 0.0001) and STEP 2 (39.6% vs. 29.5%; p = 0.0083) and the MWPC threshold for SF-36v2 Physical Functioning in STEP 1 (39.8% vs. 24.1%; p < 0.0001), STEP 2 (41.0% vs. 27.3%; p = 0.0001) and STEP 4 (18.0% vs. 6.6%; p < 0.0001). All other IWQOL-Lite-CT and SF-36v2 scale scores in STEP 1-4 were numerically improved with semaglutide 2.4 mg versus placebo, except for SF-36v2 Role Emotional in STEP 2. CONCLUSIONS: Semaglutide 2.4 mg significantly improved physical functioning, with greater proportions of participants achieving MWPC compared with placebo, and showed beneficial effects on WRQOL and HRQOL beyond physical functioning.

Long-term sustained effects of the Look AHEAD lifestyle intervention on body composition among adults with type 2 diabetes.

OBJECTIVE: The objective of the study was to test whether there are sustained effects of the Look AHEAD intensive lifestyle intervention (ILI), versus diabetes support and education (DSE), on weight and body composition 12 to 16 years after randomization. METHODS: Participants were a subset of enrollees in the Look AHEAD dual-energy x-ray absorptiometry substudy who completed the final visit, composed of men (DSE = 99; ILI = 94) and women (DSE = 134; ILI = 135) with type 2 diabetes and mean (SD) age 57.2 (6.4) years and BMI 34.9 (5.1) kg/m2 at randomization. Dual-energy x-ray absorptiometry measured total and regional fat and lean masses at randomization, at Years 1, 4, and 8, and at the final visit. Linear mixed-effects regressions were applied with adjustment for group, clinic, sex, age, race/ethnicity, and baseline body composition. RESULTS: Weight and most body compartments were reduced by 2% to 8% (and BMI 4%) in ILI versus DSE in men but not women. ILI-induced loss of lean tissue did not show a lower percent lean mass versus DSE at 16 years after randomization. CONCLUSION: ILI-related changes in weight, fat, and lean mass were detectable 12 to 16 years after randomization in men but, for unknown reasons, not in women. There was no evidence that the intervention led to a disproportionate loss of lean mass by the end of the study.

The past, present, and future of behavioral obesity treatment.

Over the last century, hundreds of evaluations have been conducted to examine weight-management interventions related to diet, physical activity, and behavior therapy. These investigations have contributed to a growing body of knowledge that has consistently advanced the field of obesity treatment, while also revealing some persistent challenges. This narrative review summarizes key findings from randomized controlled trials conducted in adults that have combined diet, physical activity, and behavior therapy, an approach variously referred to as behavioral treatment, comprehensive lifestyle modification, or intensive lifestyle intervention. The review shows that current behavioral approaches induce average reductions in baseline body weight of 5 to 10% at 6 to 12 months. Such losses have proven effective in reducing the risk of type 2 diabetes in persons with impaired glucose tolerance and in improving other obesity-related complications. These benefits have also been associated with reductions in healthcare costs. Despite these advances, behavioral treatment is challenged by the need for larger losses to achieve optimal improvements in health, by difficulties associated with maintaining weight loss, and by barriers limiting access to treatment. New anti-obesity medications, when combined with behavioral obesity treatment, hold promise of addressing the first two issues.

Psychopathology, disordered eating, and impulsivity as predictors of weight loss 24 months after metabolic and bariatric surgery.

BACKGROUND: The relationship between theoretically relevant psychosocial and behavioral variables and outcomes of metabolic and bariatric surgery remains unclear. Some studies have found that the presence of psychopathology, disordered eating, and impulsivity, either before surgery or during the early postoperative period, is associated with suboptimal postoperative weight loss. Other studies have not found these relationships. OBJECTIVE: Examine the relationship between psychopathology, disordered eating, impulsivity, and weight loss 24 months postoperatively. SETTING: Two large, urban university health systems. METHODS: Participant characteristics were collected using validated interviews, patient-reported outcome measures, and computerized assessment methods. Linear mixed effect models were used to test the association of the variables of interest on percent weight loss (%WL). RESULTS: Three hundred participants were enrolled at baseline; weight data at 24 months were available for 227 participants; between 181 and 53 individuals completed other outcome measures. The mean %WL was 23.3 ± 9.9% at 24 months. Patients who underwent Roux-en-Y gastric bypass lost more weight than those who underwent sleeve gastrectomy. The presence of subjective binge episodes at baseline was related to a greater %WL at 24 months; there were no other baseline predictors. The presence of eating disorder diagnoses and disordered eating symptoms after surgery were associated with smaller weight losses over 24 months. Current and lifetime psychopathology and impulsivity were unrelated to %WL at 24 months. CONCLUSION: Disordered eating after bariatric surgery was associated with a smaller %WL at postoperative year 2. Additional monitoring of these symptoms in the early postoperative period is recommended. Psychotherapeutic and/or dietary interventions may promote more optimal weight loss outcomes.

Randomized Controlled Trial of Effects of Behavioral Weight Loss Treatment on Food Cue Reactivity.

BACKGROUND: It is not known whether behavioral weight loss can attenuate blood oxygen level-dependent responses to food stimuli. OBJECTIVES: This randomized controlled trial assessed the effects of a commercially available behavioral weight loss program (WW, WeightWatchers) compared to a wait-list control on blood oxygen level-dependent response to food cues. METHODS: Females with obesity ( N = 61) were randomized to behavioral weight loss or wait-list control. At baseline and follow-up, participants completed assessments that included functional magnetic resonance imaging scans to assess response to images of high-calorie foods (HCF) or low-calorie foods (LCF), and neutral objects. RESULTS: There were no significant between-group differences in change from baseline to follow-up in any regions of the brain in response to viewing HCF or LCF. From baseline to follow-up, participants in behavioral weight loss, compared with wait-list control, reported significantly greater increases in desire for LCF. Changes in liking and palatability of LCF and liking, palatability, and desire for HCF did not differ between groups. DISCUSSION: Behavioral weight loss was associated with increased desire for LCF without changes in neural reactivity to food cues. These results suggest that alteration of neurological processes underlying responsiveness to food is difficult to achieve through behavioral weight management alone.

Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis.

OBJECTIVE: To explore the efficacy and safety of semaglutide 2.4 mg in people with overweight/obesity who were also being treated with antidepressants (ADs). METHODS: Across the Semaglutide Treatment Effect for People with obesity (STEP) 1-3 and 5 trials, adults with overweight/obesity and type 2 diabetes (STEP 2 only) were enrolled. People with severe major depressive disorder within 2 years prior to screening or with a patient health questionnaire-9 score ≥15 at screening were excluded. Participants were categorized into subgroups according to baseline AD status (on/off ADs) in this post hoc exploratory analysis of the STEP trials. RESULTS: Of 3683 participants randomized, 539 were on ADs at baseline. Mean body weight change from baseline to week 68 was greater for semaglutide versus placebo, regardless of baseline AD use. In STEP 1, for participants on ADs at baseline, mean change from baseline was -15.7% with semaglutide versus -0.2% with placebo and -14.7% versus -2.8% for those not on ADs at baseline. Similar patterns were seen in STEP 2, 3, and 5. The prevalence of adverse events (AEs) was generally similar between semaglutide and placebo in participants on ADs at baseline. CONCLUSIONS: In adults with overweight/obesity, semaglutide provided clinically meaningful weight loss regardless of baseline AD use, with an AE profile consistent with previous studies.

Prevalence of diagnosed psychiatric disorders among adults who have experienced and internalized weight stigma.

Objective: Experiences and internalization of weight stigma are associated with greater self-reported psychological distress and symptoms of psychiatric disorders such as depression and anxiety. However, little is known about the extent to which individuals who have experienced and internalized weight stigma are diagnosed with or provided treatment for psychiatric conditions. The current study aimed to characterize the prevalence of diagnosed psychiatric disorders among adults with obesity who had experienced and internalized weight stigma. Methods: Weight-loss treatment-seeking adults with a history of experiencing weight stigma and high levels of internalized weight stigma were recruited for two clinical trials. Results: In Study 1 (n = 84, 83.3% women, 67.9% Black), 25% of participants reported a lifetime history of a mood disorder. Few participants (<10%) reported current psychiatric diagnoses or use of psychiatric medications. In Study 2 (n = 129, 88.4% women, 65.1% white), one-third of participants reported a mood disorder history, and 21.7% reported an anxiety disorder history, with approximately 16%-18% reporting current diagnoses. In both studies, few participants reported a history of a diagnosed eating disorder despite high rates of current full- or subthreshold symptoms. Based on Beck Depression Inventory-II scores, approximately 54%-64% of participants reported mild or greater symptoms of depression. Conclusions: Overall, lifetime history of diagnosed psychiatric disorders and current symptoms of depression and eating disorders were relatively high across two samples. More research is needed to determine the impact of weight stigma on the diagnosis and treatment of eating disorders and other psychiatric concerns.

The Role of Lifestyle Modification with Second-Generation Anti-obesity Medications: Comparisons, Questions, and Clinical Opportunities.

PURPOSE OF REVIEW: This review examines lifestyle modification for obesity management with the goal of identifying treatment components that could support the use of a new generation of anti-obesity medications (AOMs). RECENT FINDINGS: Semaglutide reliably reduces baseline body weight by approximately 15% at 68 weeks, in contrast to 5-10% for lifestyle modification. Tirzepatide induces mean losses as great as 20.9%. Both medications reduce energy intake by markedly enhancing satiation and decreasing hunger, and they appear to lessen the need for traditional cognitive and behavioral strategies (e.g., monitoring food intake) to achieve calorie restriction. Little, however, is known about whether patients who lose weight with these AOMs adopt healthy diet and activity patterns needed to optimize body composition, cardiometabolic health, and quality of life. When used with the new AOMs, the focus of lifestyle modification is likely to change from inducing weight loss (through calorie restriction) to facilitating patients' adoption of dietary and activity patterns that will promote optimal changes in body composition and overall health.

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial.

The effects of tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, on weight reduction after successful intensive lifestyle intervention are unknown. This double-blind, placebo-controlled trial randomized (1:1) adults with body mass index ≥30 or ≥27 kg/m2 and at least one obesity-related complication (excluding diabetes), who achieved ≥5.0% weight reduction after a 12-week intensive lifestyle intervention, to tirzepatide maximum tolerated dose (10 or 15 mg) or placebo once weekly for 72 weeks (n = 579). The treatment regimen estimand assessed effects regardless of treatment adherence in the intention-to-treat population. The coprimary endpoint of additional mean per cent weight change from randomization to week 72 was met with changes of -18.4% (standard error (s.e.) 0.7) with tirzepatide and 2.5% (s.e. 1.0) with placebo (estimated treatment difference -20.8 percentage points (95% confidence interval (CI) -23.2%, -18.5%; P < 0.001). The coprimary endpoint of the percentage of participants achieving additional weight reduction ≥5% was met with 87.5% (s.e. 2.2) with tirzepatide and 16.5% (s.e. 3.0) with placebo achieving this threshold (odds ratio 34.6%; 95% CI 19.2%, 62.6%; P < 0.001). The most common adverse events with tirzepatide were gastrointestinal, with most being mild to moderate in severity. Tirzepatide provided substantial additional reduction in body weight in participants who had achieved ≥5.0% weight reduction with intensive lifestyle intervention. ClinicalTrials.gov registration: NCT04657016 .

Giving weight to incretin-based pharmacotherapy for obesity-related sleep apnea: a revolution or a pipe dream?

Obesity is a chronic disease affecting over 670 million adults globally, with multiple complications including obstructive sleep apnea (OSA). Substantial weight loss in patients with obesity-related OSA can reduce or even eliminate OSA as well as reduce sleepiness and improve cardio-metabolic health. Evidence suggests that these improvements exceed those that occur with device-based OSA therapies like continuous positive airway pressure which continue to be the first-line of therapy. Resistance to weight management as a first-line strategy to combat OSA could arise from the complexities in delivering and maintaining adequate weight management, particularly in sleep clinic settings. Recently, incretin-based pharmacotherapies including glucagon-like peptide 1 (GLP-1) receptor agonists alone or combined with glucose-dependent insulinotropic polypeptide (GIP) receptor agonists have been developed to target glycemic control in type 2 diabetes. These medications also slow gastric emptying and reduce energy intake. In randomized, placebo-controlled trials of these medications in diabetic and non-diabetic populations with obesity, participants on active medication lost up to 20% of their body weight, with corresponding improvements in blood pressure, lipid levels, physical functioning, and fat mass loss. Their adverse effects are predominantly gastrointestinal-related, mild, and transient. There are trials currently underway within individuals with obesity-related OSA, with a focus on reduction in weight, OSA severity, and cardio-metabolic outcomes. These medications have the potential to substantially disrupt the management of OSA. Pending coming data, we will need to consider pharmacological weight loss as a first-line therapy and how that influences training and management guidelines.

Development of a cognitive-behavioral intervention for internalized weight stigma.

Individuals with a higher body weight are the targets of pervasive social stigma. This stigma can become self-directed or internalized, leading to self-devaluation due to weight. Internalized weight stigma is associated with adverse outcomes for mental and physical health, yet little is known about how to prevent or diminish this internalization. This article introduces a novel, group-based, psychological intervention designed to reduce internalized weight stigma and its ill effects on health. Rationale is provided for the therapeutic approach and for the intervention's proposed utility in behavioral weight management settings. Intervention content is described in detail, along with preliminary evidence of its potential effects on psychological and behavioral outcomes.

A randomized controlled trial examining the effects of behavioral weight loss treatment on hippocampal volume and neurocognition.

BACKGROUND/PURPOSE: Obesity in midlife is an established risk factor for dementia. In middle-aged adults, elevated body mass index (BMI) is associated with lower neurocognition and smaller hippocampal volumes. It is unclear whether behavioral weight loss (BWL) can improve neurocognition. The purpose of this study was to evaluate whether BWL, compared to wait list control (WLC), improved hippocampal volume and neurocognition. We also examined if baseline hippocampal volume and neurocognition were associated with weight loss. METHODS: We randomly assigned women with obesity (N = 61; mean±SD age=41.1 ± 9.9 years; BMI=38.6 ± 6.2 kg/m2; and 50.8% Black) to BWL or WLC. Participants completed assessments at baseline and follow-up including T1-weighted structural magnetic resonance imaging scans and the National Institutes of Health (NIH) Toolbox Cognition Battery. RESULTS: The BWL group lost 4.7 ± 4.9% of initial body weight at 16-25 weeks, which was significantly more than the WLC group which gained 0.2 ± 3.5% (p < 0.001). The BWL and WLC groups did not differ significantly in changes in hippocampal volume or neurocognition (ps>0.05). Baseline hippocampal volume and neurocognition scores were not significantly associated with weight loss (ps>0.05). CONCLUSIONS AND IMPLICATIONS: Contrary to our hypothesis, we found no overall benefit of BWL relative to WLC on hippocampal volumes or cognition in young- and middle-aged women. Baseline hippocampal volume and neurocognition were not associated with weight loss.

Long-term effects of an internalized weight stigma intervention: A randomized controlled trial.

OBJECTIVE: To test the long-term effects of a group-based, psychological intervention designed to reduce internalized weight stigma (IWS, i.e., self-stigma), delivered in combination with behavioral weight loss (BWL) treatment, compared to BWL alone. METHOD: Adults with obesity who had experienced and IWS (N = 105, Mage = 49 years, 90.5% women, 70.5% White, 24.8% Black, MBMI = 38 kg/m²) were randomized to receive BWL with the Weight Bias Internalization and Stigma (BIAS) Program or BWL alone. Participants received weekly group treatment for 20 weeks, followed by 52 weeks of monthly and every-other-month sessions. Percent weight change at Week 72 was the primary outcome, with secondary outcomes of weight change at other time points; physical activity (measured by accelerometry, interview, and self-report); cardiometabolic risk factors; and psychological and behavioral outcomes. Intention-to-treat analyses used linear mixed models to test for between-group differences. Treatment acceptability was assessed. RESULTS: Participants in the BWL + BIAS versus BWL group lost 2 percentage points more of baseline weight at Week 72, which was not a significant difference (mean weight change = -7.2% vs. -5.2%, 95% CI [-4.6 to 0.6], p = 0.14, d = 0.18). The BWL + BIAS (vs. BWL) group produced significantly greater improvements in weight self-stigma, eating self-efficacy, and some aspects of quality of life at specific time points. Most outcomes improved significantly over time but did not differ between groups. The trial had high retention and treatment acceptability, with higher ratings in the BWL + BIAS versus BWL group. CONCLUSIONS: No significant differences in weight loss were observed between the BWL + BIAS versus BWL group. Possible benefits of addressing weight stigma in weight management warrant further investigation. (PsycInfo Database Record (c) 2023 APA, all rights reserved).