RECRUITING

RemI for Post-Bariatric Surgery Weight Regain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of a Remotely-Delivered Behavioral Intervention for Post-Bariatric Surgery Weight Regain

Quick Facts

Study Start:2024-04-15
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06292936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women
  2. * Ages 18-70 years old
  3. * Weight regain of at least 5% from lowest postoperative weight
  4. * Underwent gastric bypass or sleeve gastrectomy within 6 to 48 months prior to enrollment
  5. * Ability to give consent
  6. * Ability to speak, write, and understand English
  1. * Long-term treatment with oral steroids
  2. * Current use of weight loss medication (OTC or prescription)
  3. * Current pregnancy or plan to become pregnant within 12 months
  4. * Psychiatric hospitalization in the past 6 months
  5. * Documented or self-reported psychiatric diagnosis that would interfere with adherence to the study protocol or acute suicidality
  6. * Self-report of alcohol or substance abuse within the past 12 months
  7. * Current, self-reported use of tobacco products
  8. * Weight loss \> 10 lbs in the past 3 month
  9. * History of more than one bariatric procedure
  10. * Inability to walk at least one city block without assistance

Contacts and Locations

Study Locations (Sites)

Rush University
Chicago, Illinois, 60612
United States
Temple University
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Temple University

Study Record Dates

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

Study Start Date2024-04-15
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2024-04-15
Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity
  • Bariatric Surgery Candidate