NCT06292936Recruiting
RemI for Post-Bariatric Surgery Weight Regain
Evaluation of a Remotely-Delivered Behavioral Intervention for Post-Bariatric Surgery Weight Regain
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 9 Feb 2024
- Start date
- 15 Apr 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Temple University
- Diseases
- Obesity
- NCT number
- NCT06292936
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 15 Apr 2024 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Long-term treatment with oral steroids
- Current use of weight loss medication (OTC or prescription)
Other illness
- 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
- History of more than one bariatric procedure
Other
- Current pregnancy, plan to become pregnant within 12 months, lactation within the past 6 months
- 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
- Inability to walk at least one city block without assistance
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RUSH University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Temple University Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.