Project VIBE: Virtual Intervention for Binge Eating in Adolescents (VIBE)

July 6, 2026 updated by: Andrea Goldschmidt, University of Pittsburgh

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60208
        • Northwestern University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Feasibility/Efficacy Testing Participants
All participants will all be assigned to the experimental group in this single-arm open trial.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 16
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).
Week 16
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).
Through study completion (up to 9 months)
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).
Through study completion (up to 9 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention assessment
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).
Through study completion (up to 9 months)
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)
Through study completion (up to 9 months)
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).
Through study completion (up to 9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea B Goldschmidt, Ph.D., University of Pittsburgh
  • Principal Investigator: Andrea K Graham, Ph.D., Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY23020100
  • R01DK136540-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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