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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Drexel University
RECRUITING
Philadelphia
Time Frame
Start Date: 2025-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
Experimental: Self-Help Digital Intervention
All study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm.
Related Therapeutic Areas
Sponsors
Collaborators: Oui Therapeutics, Inc., National Institute of Mental Health (NIMH)
Leads: Drexel University

This content was sourced from clinicaltrials.gov

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