A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity

February 13, 2025 updated by: Drexel University
The proposed study is an open label, non randomized, waitlist controlled single group feasibility study of the feasibility and usability of a digital intervention (called ChangeBite) to be used by individuals with obesity and comorbid binge eating behavior. The proposed research will include approximately 30 participants. Participants will be recruited for this single group pilot trial using online advertising to attend a virtual screening session. Screened participants willing and eligible to participate, will receive informed consent and formally start ChangeBite. Participants will be instructed to engage with ChangeBite and attend follow up assessments on scheduled video calls. Feasibility and acceptability of implementation will be assessed by collecting data on recruitment, retention, usability and satisfaction. The research team will also collect assessment data from participants on feasibility, and usability. In addition to self report scales, semi-structured interviews will be completed with a trained research team member via video call and will be partially recorded. Assessments will be done at baseline, 12 weeks, and 24 weeks. Participants' app use frequency and duration will be tracked using software analytics. Participants' body weight will be captured weekly using a timestamped picture of their weight as it appears on their scale and Body Mass Index will be calculated with these data points.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Recruiting
        • Drexel University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephanie Dr. Manasse, PhD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Are English speaking male or female
  2. Are aged 18-70 years
  3. Have recurrent objective or subjective binge eating episodes (≥12 episodes in 3 months)
  4. Have BMI ≥30
  5. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
  6. Are willing and able to complete enrollment procedures
  7. Are able to understand the nature of the study and provide written informed consent

Exclusion Criteria:

  1. Are unable to fluently speak, write and read English.
  2. Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment from another provider)
  3. Are receiving weight loss treatment (behavioral or pharmacological)
  4. Have a mental handicap or are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., imminent or high risk for suicide, substance use disorder, active psychotic disorder,)
  5. Are purging and/or using laxatives 3 or more times per week and are not deemed safe for remote treatment by a primary care provider.
  6. Are exercising 2 or more hours a day on average, or engaging in significantly harmful compensatory behaviors (i.e., > 3x/week of self-induced vomiting or laxative use), and are not deemed safe for remote treatment by a primary care provider.
  7. Are fasting for 24 hours or more, > 3x times a week, and are not deemed safe for remote treatment by a primary care provider.
  8. Are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate.
  9. Are pregnant or planning to become pregnant within the next year.
  10. Are individuals who are not yet adults (infants, children, teenagers) Are currently taking any of these medications: Haldol, Loxitane, Mellaril, Moban, Navane, Prolixin, Serentil, Stelaxine, Trilafon, Thoraxine, Abilify, Clozaril, Geodon, Risperdal, Seroquel, Zyprexa
  11. Are adults unable to consent
  12. Are prisoners

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Help Digital Intervention
All study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm.
Other: Digital
This intervention is a self-help digital treatment, delivered via a smartphone application, for adults with co-morbid binge eating and obesity. The app ChangeBite will integrate principles of evidence based treatments for obesity (behavioral weight loss treatment) and binge eating (cognitive behavioral therapy, acceptance and commitment therapy) into a highly personalized, self-guided, program that leverages an artificial conversational agent and Just-In-Time-Adaptive-Interventions (JITAIs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binge eating episodes
Time Frame: 3 months
The frequency of binge eating episodes.
3 months
Weight
Time Frame: 3 months
Weight loss during the intervention.
3 months

Collaborators and Investigators

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

Sponsor

Drexel University

Collaborators

National Institute of Mental Health (NIMH)
Oui Therapeutics, Inc.

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 (Estimated)

February 1, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2408010718
  • R41MH134704 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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