Recruiting

RemI

Sponsor:

Temple University

Code:

NCT06292936

Conditions

Obesity

Bariatric Surgery Candidate

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Acceptance-Based Behavioral Intervention

Study Details

Brief summary:

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 ID

NCT06292936

Start date

Apr 15, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acceptance-Based Behavioral Intervention

Participants assigned to ABTi will receive a remotely delivered intervention consisting of 20 modules over 6 months. Based on theory derived from acceptance and mindfulness approaches, the intervention provides psychological strategies to facilitate engagement in weight control behaviors. Each module includes a video presentation of material synchronized with a slideshow illustrating session material, interactive features, quizzes that will ensure participants have mastered the material, and directed assignments to be completed throughout the week. Participants will be assigned to view each module, self-monitor their daily food intake, and weigh themselves weekly. At the completion of each module, a brief call with a coach will be scheduled to discuss and clarify the content of the session, review homework, and provide feedback on food records and weekly weights.

no intervention: Control

Participants assigned to the Control condition will receive telephone contacts from the coaches on the same schedule as those who receive ABTi. The content will focus on the (re) delivery of the dietary and behavioral instruction that patients received prior to bariatric surgery. For example, participants will be reminded to consume reduced portion sizes, avoid foods higher in sugar and fat, and eat discrete meals throughout the day. They will receive a Wi-Fi scale and will be asked to weigh themselves weekly, similar to those receiving ABTi.

Interventions

Acceptance-Based Behavioral Intervention

Intervention will evaluate acceptance-based behavioral treatment (ABT) for individuals who are experiencing weight regain after bariatric surgery. ABT builds acceptance and mindfulness skills that increase the capacity to experience uncomfortable internal states (e.g., food cravings, hunger, negative affect). Online treatments include video modules demonstrating session content as well as interactive features. These interventions are particularly desirable, reduced participant burden, and are cost effective.

ABT provides patients unique skills that directly target causes of dietary non-adherence. ABT provides patients specialized skills to directly target causes of dietary nonadherence (rather that solely repeating behavioral strategies they received during preoperative medical weight management required by their third party payers and bariatric surgery programs).

Primary outcome measure

  • Weight [ Time Frame: 12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month) ]

Central Contacts and Locations

Central contacts

David B Sarwer, PhD

215-707-8632dsarwer@temple.edu

Sarah R Fischbach, MPH

215-707-8633sarah.fischbach@temple.edu

Locations

Rush University

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Lauren Bradley, PhD

312-942-2714lauren_e_bradley@rush.edu

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

David B Sarwer, PhD

215-707-8632dsarwer@temple.edu

Sarah R Fischbach, MPH

215-707-8633sarah.fischbach@temple.edu

More Information

Sponsor

Temple University

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Keywords

  • Acceptance-Based Behavioral Therapy
  • Postoperative Outcomes
  • Weight Regain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2026-04-03.