Project VIBE: Virtual Intervention for Binge Eating in Adolescents

NCT ID: NCT06819813

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Feasibility/Efficacy Testing Participants

All participants will all be assigned to the experimental group in this single-arm open trial.

Group Type: EXPERIMENTAL

Feasibility/Efficacy Testing

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Andrea Goldschmidt

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea B Goldschmidt, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Andrea K Graham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin R Stalvey, MPH

Role: CONTACT

stalveyer@upmc.edu

4125869066

Andrew Tyler, BS

Role: CONTACT

tylerab2@upmc.edu

Facility Contacts

Nathan Winquist, MS

Role: primary

nathan.winquist@northwestern.edu

Erin R Stalvey, MPH

Role: primary

stalveyer@upmc.edu

4125869066

Andrew Tyler, BS

Role: backup

tylerab2@upmc.edu

Other Identifiers

R01DK136540-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23020100

Identifier Type: -

Identifier Source: org_study_id