Clinical trial NCT06819813: Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Official title: Open Trial of a Technology-Based Intervention for Dysregulated Eating in Adolescents With or At Risk for Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Binge-Eating Disorder
Binge Eating
Keywords: Mobile Intervention
Adolescent
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-02-11
Enrollment: 140
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Usability of intervention
timeFrame: Week 16
measure: Acceptability of intervention
timeFrame: Week 16
measure: Body mass index percentile
timeFrame: Through study completion (up to 9 months)
measure: Dysregulated eating
timeFrame: Through study completion (up to 9 months)
Secondary outcomes:
Other outcomes:
measure: Comorbid diagnoses
timeFrame: Pre-intervention assessment
measure: Intervention targets (activity patterns)
timeFrame: Through study completion (up to 9 months)
measure: Intervention targets (dietary patterns)
timeFrame: Through study completion (up to 9 months)
measure: Putative treatment mechanisms (general)
timeFrame: Through study completion (up to 9 months)
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Andrea B Goldschmidt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Andrea K Graham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: