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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Drexel University
Study ID
NCT06817863
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Binge Eating Disorder
  • Binge Eating Disorder Associated With Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Self-Help Digital Intervention
    All study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm.

Primary Outcome Measure

Binge eating episodes [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Drexel UniversityPhiladelphiaPennsylvania19139
Stephanie Dr. Manasse, PhD
[email protected]
510-520-6362
Alexandra Mouangue, BA
[email protected]
2408838111
Stephanie Dr. Manasse, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By research site
Drexel University· Philadelphia, PA

Related Studies