NCT06292936

RemI for Post-Bariatric Surgery Weight Regain

Evaluation of a Remotely-Delivered Behavioral Intervention for Post-Bariatric Surgery Weight Regain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100). The main research aims are: 1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control. 2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups. 3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior.

Detailed description

The current study will evaluate a remotely-delivered acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery (\> 5% from their lowest postoperative weight and after postoperative Month 6). ABTi will be delivered online via interactive modules followed by brief phone calls with health coaches to reinforce the lessons over the course of 6 months. We aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100). Assessments will be conducted at baseline, and 3, 6 (end of active treatment), and 12 months after enrollment. Seven-day, smartphone-based, Ecological Momentary Assessment (EMA) will be used at each period to precisely measure how aversive internal states drive maladaptive eating patterns that contribute to weight regain and how ABT works to interrupt these patterns to reverse risk and restore a healthy pattern of eating. The study has two primary aims and an exploratory aim. Aim 1: To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or C. (The study is powered on this outcome.) Hypothesis: Participants who receive ABTi will achieve greater reductions in weight at 12 months as compared to those who receive C. Aim 2: To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups. Hypothesis: Participants who receive ABTi will report lower caloric intake, greater reductions in maladaptive eating behaviors, greater increases in physical activity, and demonstrate more favorable improvements in weight-related comorbidities than those who receive C. Aim 3 (Exploratory): To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior. Hypotheses: a) Changes in ABT variables from baseline to mid-treatment will mediate differences in weight outcomes between conditions from midtreatment to post-treatment; b) The association between eating behavior and subjective states (i.e., hunger, cravings) will weaken in ABTi compared to C from baseline to post-treatment.

Conditions

• Obesity
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance-Based Behavioral Intervention	Intervention will evaluate acceptance-based behavioral treatment (ABT) for individuals who are experiencing weight regain after bariatric surgery. ABT builds acceptance and mindfulness skills that increase the capacity to experience uncomfortable internal states (e.g., food cravings, hunger, negative affect). Online treatments include video modules demonstrating session content as well as interactive features. These interventions are particularly desirable, reduced participant burden, and are cost effective. ABT provides patients unique skills that directly target causes of dietary non-adherence. ABT provides patients specialized skills to directly target causes of dietary nonadherence (rather that solely repeating behavioral strategies they received during preoperative medical weight management required by their third party payers and bariatric surgery programs).

Timeline

• Start date: 2024-04-15
• Primary completion: 2027-12-31
• Completion: 2028-05-31
• First posted: 2024-03-05
• Last updated: 2026-04-03

Locations

2 sites across 1 country: United States