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Active, Not Recruiting

NCT Number: NCT06819813

Project VIBE: Virtual Intervention for Binge Eating in Adolescents

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Binge Eating Binge-Eating Disorder Body Weight Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feasibility/Efficacy Testing

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.

Primary outcomes

  1. Usability of intervention

    Time frame: Week 16

    Perceptions that the intervention is or would be useful, useable, and satisfactory will be measured by the System Usability Scale.

  2. Acceptability of intervention

    Time frame: Week 16

    Perceptions that the intervention is or would be useful, useable, and satisfactory will be measured by the Usefulness, Satisfaction, and Ease of use questionnaire (USE).

  3. Body mass index percentile

    Time frame: Through study completion (up to 9 months)

    Adolescents will have their height and weight measured to calculate body mass index percentile using nationally representative growth charts and accompanying procedures. These data will be collected at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment).

  4. Dysregulated eating

    Time frame: Through study completion (up to 9 months)

    Dysregulated eating (overeating and loss of control eating episodes) will be measured using the Eating Disorder Examination (EDE; interview and questionnaire). The EDE features 4 subscales that are rated on a 7-point forced-choice format (0-6), with higher scores reflecting greater severity or frequency. These measures will be completed at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment).

Other outcomes

  1. Comorbid diagnoses

    Time frame: Pre-intervention assessment

    Comorbid psychiatric diagnoses will be reported by the adolescent's caregiver using the Child and Adolescent Symptom Inventory (CASI). Medical comorbid diagnoses will be reported by both the adolescent and their caregiver.

  2. Intervention targets (activity patterns)

    Time frame: Through study completion (up to 9 months)

    Activity patterns (intervention target) will be measured using FitBit data during the intervention. Adolescents will track their activity using the FitBit over a 1-week period at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment).

  3. Intervention targets (dietary patterns)

    Time frame: Through study completion (up to 9 months)

    Dietary patterns (intervention target) will be measured using phone-based 24-hour dietary recalls. Adolescents will complete 3 food recalls over a 1-week period at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment)

  4. Putative treatment mechanisms (general)

    Time frame: Through study completion (up to 9 months)

    General self-regulation (putative mechanism) will be measured using the Self-Regulation Questionnaire. Items on the Self-Regulation Questionnaire are scored from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicated higher self-regulation abilities. The questionnaire will be completed at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Northwestern University

Registry information

Official study title

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

Acronym: VIBE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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