RemI for Post-Bariatric Surgery Weight Regain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTemple University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Acceptance-Based Behavioral Intervention

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Temple University

Lead sponsor

Rush University

Collaborator