RemI for Post-Bariatric Surgery Weight Regain
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.
Conditions:
🦠 Obesity
🦠 Bariatric Surgery Candidate
🗓️ Study Start (Actual)
15 April 2024
🗓️ Primary Completion (Estimated)
31 December 2027
✅ Study Completion (Estimated)
1 April 2028
👥 Enrollment (Estimated)
200
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Chicago, Illinois, United States
📍
Philadelphia, Pennsylvania, United States
Description
Inclusion Criteria:
- * Men and women
- * Ages 18-70 years old
- * Weight regain of at least 5% from lowest postoperative weight
- * 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 or plan to become pregnant within 12 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
Ages Eligible for Study:
18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Yes
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
9 February 2024
- First Submitted that Met QC Criteria
27 February 2024
- First Posted
5 March 2024
Study Record Updates
- Last Update Submitted that Met QC Criteria
10 July 2024
- Last Update Posted
15 July 2024
- Last Verified
July 2024