BridgeMD
New treatment option for Obesity
Official title RemI for Post-Bariatric Surgery Weight Regain
ClinicalTrials.gov ID: NCT06292936
What this study is testing
- What it's testing
- 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).
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.