Project VIBE: Virtual Intervention for Binge Eating in Adolescents
VIBE
Open Trial of a Technology-Based Intervention for Dysregulated Eating in Adolescents With or At Risk for Overweight or Obesity
2 other identifiers
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jul 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
July 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
April 24, 2026
April 1, 2026
1.3 years
January 28, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Usability of intervention
Perceptions that the intervention is or would be useful, useable, and satisfactory will be measured by the System Usability Scale.
Week 16
Acceptability of intervention
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).
Week 16
Body mass index percentile
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).
Through study completion (up to 9 months)
Dysregulated eating
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).
Through study completion (up to 9 months)
Other Outcomes (4)
Comorbid diagnoses
Pre-intervention assessment
Intervention targets (activity patterns)
Through study completion (up to 9 months)
Intervention targets (dietary patterns)
Through study completion (up to 9 months)
- +1 more other outcomes
Study Arms (1)
Feasibility/Efficacy Testing Participants
EXPERIMENTALAll participants will all be assigned to the experimental group in this single-arm open trial.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northwestern University
Chicago, Illinois, 60208, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Goldschmidt AB, Ortega A, Rooper IR, Obleada KT, Chapa DAN, Silverberg B, Stalvey E, Camino MK, Levine MD, Yu L, Eichen DM, Graham AK. Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents. Contemp Clin Trials. 2026 Feb;161:108192. doi: 10.1016/j.cct.2025.108192. Epub 2025 Dec 18.
PMID: 41421758DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea B Goldschmidt, Ph.D.
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Andrea K Graham, Ph.D.
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
January 28, 2025
First Posted
February 11, 2025
Study Start
July 14, 2025
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
May 30, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
Research data from participants may be shared with the broader scientific community after publication. We will make data and documentation available only under a data-sharing agreement that provides for a commitment to: (1) use the data for research purposes only; (2) secure the data using appropriate computer technology; (3) destroy or return the data after analyses are completed; and (4) not attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.