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RemI for Post-Bariatric Surgery Weight Regain

RecruitingNAAges 18 Years - 70 YearsAllTemple University
NCT06292936 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 \>

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📋 Eligibility rules (as published)
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
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What it tests

  • Acceptance-Based Behavioral Intervention
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Where

2 sites
Rush University
Chicago, United States
Temple University
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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