RecruitingNot ApplicableNCT06292936

RemI for Post-Bariatric Surgery Weight Regain

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


Sponsor

Temple University

Enrollment

200 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

  • 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 Criteria10

  • 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

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Interventions

BEHAVIORALAcceptance-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).


Locations(2)

Rush University

Chicago, Illinois, United States

Temple University

Philadelphia, Pennsylvania, United States

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NCT06292936


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