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

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.

NCT Number	NCT06817863
Lead Sponsor	Drexel University Collaborators: National Institute of Mental Health (NIMH), Oui Therapeutics, Inc.
Conditions	Binge Eating Disorder Associated With Obesity, Binge Eating Disorder
Enrollment	30 participants
Start Date	2025-02
Primary Completion	2025-06 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-02-17