NCT06819813

Project VIBE: Virtual Intervention for Binge Eating in Adolescents

Open Trial of a Technology-Based Intervention for Dysregulated Eating in Adolescents With or At Risk for Overweight or Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is part of a multi-phase project to create and test a mobile app intervention aimed at helping teenagers regulate their eating behaviors. Participation in this trial involves the following: 1. Adolescents and their parent are asked to attend a virtual assessment visit, where they will provide consent and complete questionnaires on eating-related thoughts and behaviors, mood, and experience with technology. The adolescent will also be asked to complete a semi-structured interview and provide height/weight measurements. 2. Eligible adolescents are then asked to complete a test-run week to make sure the trial is a good fit for them. They will be mailed a FitBit to wear continuously during the test-run week and a Smartscale to record their weight. They will also complete three 24-hour food recalls with a member of the research team during this week. Depending on engagement, the adolescent may or may not be invited to participate in the 16-week trial. 3. Adolescents eligible for the trial will use the VIBE app (Virtual Intervention for Binge Eating) and receive coaching for 16 weeks. Participants will also be asked to download an app that will help them with skill building and problem solving through short tasks/games, to be used while they are participating in the 16-week intervention. 4. Throughout the trial, adolescents will be invited to complete 3 additional assessment visits: "mid-point" or 8 weeks after starting the intervention, "post-intervention" at the end of the 16-week intervention, and "follow-up" 4 months after completing the intervention. These study assessments will include an interview, a weight measurement using the Smartscale, Fitbit usage for one week, up to 3 dietary recall phone calls, computerized tasks to assess how they think and solve problems, and online surveys. Each assessment will take about 90 - 120 minutes to complete.

Conditions

• Obesity
• Binge-Eating Disorder
• Binge Eating

Interventions

Type	Name	Description
BEHAVIORAL	Feasibility/Efficacy Testing	This digital intervention will include elements of adapted cognitive-behavioral treatment for adolescent binge eating and weight control, with a focus on self-regulation and skills use.

Timeline

• Start date: 2025-06-02
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2025-02-11
• Last updated: 2025-08-28

Locations

2 sites across 1 country: United States