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

NCT ID: NCT06817863

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-Help Digital Intervention

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

Group Type: EXPERIMENTAL

Digital

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Oui Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Stephanie Dr. Manasse, PhD

Role: primary

smm522@drexel.edu

510-520-6362

Alexandra Mouangue, BA

Role: backup

am5562@drexel.edu

2408838111

Other Identifiers

R41MH134704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2408010718

Identifier Type: -

Identifier Source: org_study_id