Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06292936

RemI for Post-Bariatric Surgery Weight Regain

Led by Temple University · Updated on 2026-04-03

200

Participants Needed

2

Research Sites

215 weeks

Total Duration

On this page

Sponsors

T

Temple University

Lead Sponsor

R

Rush University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

RemI for Post-Bariatric Surgery Weight Regain

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women
  • Ages 18 to 70 years old
  • Weight regain of more than 5% from lowest postoperative weight
  • Body mass index (BMI) of 25 or above
  • Underwent gastric bypass or sleeve gastrectomy within 6 to 48 months before enrollment
  • Ability to give consent
  • Ability to speak, write, and understand English
Not Eligible

You will not qualify if you...

  • Long-term treatment with oral steroids
  • Current use of any weight loss medication (over-the-counter or prescription)
  • Current pregnancy, planning pregnancy within 12 months, or lactation within past 6 months
  • Psychiatric hospitalization within past 6 months
  • Psychiatric diagnosis interfering with study adherence or acute suicidality
  • Alcohol or substance abuse within past 12 months
  • Current use of tobacco products
  • Weight loss greater than 10 pounds in past 3 months
  • History of more than one bariatric procedure
  • Inability to walk at least one city block without assistance

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Rush University

Chicago, Illinois, United States, 60612

Actively Recruiting

2

Temple University

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

D

David B Sarwer, PhD

CONTACT

S

Sarah R Fischbach, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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