No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Temple University · Other
Who this trial is looking for
This trial is looking for adults who have regained weight after bariatric surgery. Participants will receive support to help them manage their weight over 12 months.
Are You a Good Fit for This Trial?
Rules you outHistory of more than one bariatric procedureInability to walk at least one city block without assistance
You may be able to join if
I am between 18 and 70 years old
I have regained at least 5% of my lowest weight after surgery
My body mass index (BMI) is 25 or above
I had gastric bypass or sleeve gastrectomy in the past 6 to 48 months
I can give my consent
I can speak, write, and understand English
You may not be able to join if
I have been taking oral steroids for a long time
I am currently using weight loss medication
I am pregnant or plan to become pregnant in the next year
I have been hospitalized for psychiatric reasons in the past 6 months
I have a psychiatric diagnosis that affects my ability to follow the study
I have reported alcohol or substance abuse in the past 12 months
I currently use tobacco products
I have lost more than 10 lbs in the past 3 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 reg…
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.
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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, wri…
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
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