Project VIBE: Virtual Intervention for Binge Eating in Adolescents

University of Pittsburgh

Status

Enrolling

Conditions

Binge-Eating Disorder

Binge Eating

Obesity

Treatments

Behavioral: Feasibility/Efficacy Testing

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06819813

R01DK136540-01 (U.S. NIH Grant/Contract)

STUDY23020100

Details and patient eligibility

About

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.

Full 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:

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.
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.
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.
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.

Enrollment

140 estimated patients

Sex

All

Ages

13 to 19 years old

Volunteers

No Healthy Volunteers

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