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RemI for Post-Bariatric Surgery Weight Regain

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "ABTi will be delivered online via interactive modules followed by brief phone calls with health coaches to reinforce the lessons over the course of 6 months."
  • "Aim 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 C. (The study is powered on this outcome.) Hypothesis: Participants who receive ABTi will achieve greater reductions in weight at 12 months as compared to those who receive C."
  • "Aim 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether remote coaching in acceptance-based skills can help people lose weight they regained after weight-loss surgery. These skills help people handle thoughts and feelings that affect eating. The study compares this coaching with brief phone calls that review diet and behavior advice, and tracks weight and health over 12 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men and women ages 18 to 70.
  • Regained at least 5% of the weight from their lowest weight after surgery.
  • Have a body mass index (BMI) of at least 25. BMI is a measure based on height and weight.
  • Had gastric bypass or sleeve gastrectomy, two types of weight-loss surgery, 6 to 48 months before joining.
  • Can give consent to join the study.
  • Can speak, write, and understand English.

Who can't join

  • Take steroid pills long term or currently use any weight-loss medicine, with or without a prescription.
  • Are pregnant, plan to become pregnant within 12 months, or have breastfed or produced breast milk in the past 6 months.
  • Had a hospital stay for mental health care in the past 6 months, have a mental health condition that would prevent following study rules, or are at immediate risk of suicide.
  • Report alcohol or drug abuse in the past 12 months, or currently use tobacco products.
  • Lost more than 10 pounds in the past 3 months.
  • Have had more than one weight-loss surgery.
  • Cannot walk at least one city block without help.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

IL

PA