Remote intervention for weight regain after bariatric surgery
Evaluation of a Remotely-Delivered Behavioral Intervention for Post-Bariatric Surgery Weight Regain
NA · Temple University · NCT06292936
This study is testing if a new remote program can help people who have gained weight after bariatric surgery lose that weight and improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Temple University (other) |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT06292936 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a remotely-delivered acceptance-based behavioral intervention (ABTi) for bariatric surgery patients who have experienced significant weight regain postoperatively. Participants will be randomly assigned to either the ABTi group or a control group that receives standard dietary and behavioral guidance. The study will assess changes in body weight and related behaviors over a 12-month period, focusing on individuals who have regained more than 5% of their lowest postoperative weight. The goal is to determine if ABTi can effectively reverse weight regain and improve weight-related health outcomes.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-70 who have regained at least 5% of their weight after undergoing gastric bypass or sleeve gastrectomy within the last 6 to 48 months.
Not a fit: Patients currently using weight loss medications, those with recent psychiatric issues, or those who have lost significant weight recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help patients regain control over their weight and improve their overall health after bariatric surgery.
How similar studies have performed: Other studies have shown promise with behavioral interventions for weight management, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Rush University — Chicago, Illinois, United States (RECRUITING)
- Temple University — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: David B Sarwer, PhD — Temple University
- Study coordinator: David B Sarwer, PhD
- Email: dsarwer@temple.edu
- Phone: 215-707-8632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Bariatric Surgery Candidate, Acceptance-Based Behavioral Therapy, Postoperative Outcomes, Weight Regain