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

NCT06817863 | Recruiting Phase 1 DMC

• 2 other identifiers: 2408010718R41MH134704
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Binge Eating Disorder Associated With Obesity; Binge Eating Disorder

Keywords

digital treatment; self-help intervention; binge eating

Outcome Measures

Primary Outcomes (2)

• Binge eating episodes

  The frequency of binge eating episodes.

  3 months

• Weight

  Weight loss during the intervention.

  3 months

Study Arms (1)

Self-Help Digital Intervention

EXPERIMENTAL

All study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm.

Other: Digital

Interventions

Digital OTHER

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).

Self-Help Digital Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Are unable to fluently speak, write and read English.
• Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment from another provider)
• Are receiving weight loss treatment (behavioral or pharmacological)
• 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,)
• 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.
• 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.
• Are fasting for 24 hours or more, \> 3x times a week, and are not deemed safe for remote treatment by a primary care provider.
• Are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate.
• Are pregnant or planning to become pregnant within the next year.
• 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
• Are adults unable to consent
• Are prisoners

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Mental Health (NIMH): collaborator
• Oui Therapeutics, Inc.: collaborator

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19139, United States

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)