Project VIBE: Virtual Intervention for Binge Eating in Adolescents (NCT06819813) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
United States50 participantsStarted 2025-07-14
Plain-language summary
The aim of this project is to pilot test a novel mobile app intervention for adolescents with dysregulated eating behaviors and elevated weight status. This intervention will incorporate evidence-informed strategies targeting self-regulation into cognitive-behavioral treatment for maladaptive eating. Adolescents will use the app for 16 weeks and provide feedback on its usability and effectiveness in managing dysregulated eating.
Who can participate
Age range
13 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI≥75th percentile for their age and sex
* Report recent loss of control eating and/or overeating (≥3 episodes of either type of eating behavior in the past 3 months)
* Have an email address, Smartphone, and regular access to the internet
* Be willing and able to measure their height and weight prior to study enrollment
Exclusion Criteria:
* Report more than 2 instances of compensatory behavior (e.g. diuretics, laxatives, vomiting, driven exercise) in the past 3 months
* Not fluent in English at a third-grade reading level or higher
* Currently taking medications known to affect weight or appetite or concurrently involved in treatment for eating or weight disorders
* Meet criteria for a medical or psychiatric condition (e.g., diabetes, bulimia nervosa) known to significantly affect eating or weight, aside from binge eating disorder
* Developmental or cognitive delay precluding participation in the intervention
* Currently pregnant or lactating
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Usability of intervention
Timeframe: Week 16
2
Acceptability of intervention
Timeframe: Week 16
3
Body mass index percentile
Timeframe: Through study completion (up to 9 months)
4
Dysregulated eating
Timeframe: Through study completion (up to 9 months)