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RemI for Post-Bariatric Surgery Weight Regain
Evaluation of a Remotely-Delivered Behavioral Intervention for Post-Bariatric Surgery Weight Regain
Who can join
Ages 18 to 70 · All sexes · Healthy volunteers welcome
Full 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
About the study
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.
What is being tested
- Acceptance-Based Behavioral Intervention (behavioral)
Sponsor: Temple University · Participants: 200 · Started: Apr 15, 2024
Contact the study team
- David B Sarwer, PhD · Phone: 215-707-8632
- Sarah R Fischbach, MPH · Phone: 215-707-8633
Official record on ClinicalTrials.gov — NCT06292936
Locations in the U.S.
| Illinois | Rush University, Chicago |
| Pennsylvania | Temple University, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.