RemI for Post-Bariatric Surgery Weight Regain

NCT ID: NCT06292936

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2028-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acceptance-Based Behavioral Intervention

Participants assigned to ABTi will receive a remotely delivered intervention consisting of 20 modules over 6 months. Based on theory derived from acceptance and mindfulness approaches, the intervention provides psychological strategies to facilitate engagement in weight control behaviors. Each module includes a video presentation of material synchronized with a slideshow illustrating session material, interactive features, quizzes that will ensure participants have mastered the material, and directed assignments to be completed throughout the week. Participants will be assigned to view each module, self-monitor their daily food intake, and weigh themselves weekly. At the completion of each module, a brief call with a coach will be scheduled to discuss and clarify the content of the session, review homework, and provide feedback on food records and weekly weights.

Group Type: EXPERIMENTAL

Acceptance-Based Behavioral Intervention

Intervention Type: BEHAVIORAL

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).

Control

Participants assigned to the Control condition will receive telephone contacts from the coaches on the same schedule as those who receive ABTi. The content will focus on the (re) delivery of the dietary and behavioral instruction that patients received prior to bariatric surgery. For example, participants will be reminded to consume reduced portion sizes, avoid foods higher in sugar and fat, and eat discrete meals throughout the day. They will receive a Wi-Fi scale and will be asked to weigh themselves weekly, similar to those receiving ABTi.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and women
• Ages 18-70 years old
• Weight regain of at least 5% from lowest postoperative weight
• Body mass index (BMI) 25 or above
• Underwent gastric bypass or sleeve gastrectomy within 6 to 48 months prior to enrollment
• Ability to give consent
• Ability to speak, write, and understand English

Exclusion Criteria

• Long-term treatment with oral steroids
• Current use of weight loss medication (OTC or prescription)
• Current pregnancy, plan to become pregnant within 12 months, lactation within the past 6 months
• Psychiatric hospitalization in the past 6 months
• Documented or self-reported psychiatric diagnosis that would interfere with adherence to the study protocol or acute suicidality
• Self-report of alcohol or substance abuse within the past 12 months
• Current, self-reported use of tobacco products
• Weight loss > 10 lbs in the past 3 month
• History of more than one bariatric procedure
• Inability to walk at least one city block without assistance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David B Sarwer, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Rush University

Chicago, Illinois, United States

Site Status: RECRUITING

Temple University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David B Sarwer, PhD

Role: CONTACT

dsarwer@temple.edu

215-707-8632

Sarah R Fischbach, MPH

Role: CONTACT

sarah.fischbach@temple.edu

215-707-8633

Facility Contacts

Lauren Bradley, PhD

Role: primary

lauren_e_bradley@rush.edu

312-942-2714

David B Sarwer, PhD

Role: primary

dsarwer@temple.edu

215-707-8632

Sarah R Fischbach, MPH

Role: backup

sarah.fischbach@temple.edu

215-707-8633

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Identifier Source: org_study_id