Actively Recruiting
A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity
Led by Drexel University · Updated on 2025-02-17
30
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
D
Drexel University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Are unable to fluently speak, write and read English
- Are already receiving treatment for an eating disorder
- Are receiving weight loss treatment (behavioral or pharmacological)
- Have a mental handicap or severe psychopathology limiting study engagement (e.g., high suicide risk, substance use disorder, active psychotic disorder)
- Are purging and/or using laxatives 3 or more times per week and not deemed safe for remote treatment
- Are exercising 2 or more hours daily or engaging in harmful compensatory behaviors >3 times/week and not deemed safe for remote treatment
- Are fasting for 24 hours or more, >3 times a week, and not deemed safe for remote treatment
- Are unwilling to receive medical clearance or monitoring as requested
- Are pregnant or planning pregnancy within the next year
- Are not adults (infants, children, teenagers)
- Are currently taking specified antipsychotic medications
- Are adults unable to consent
- Are prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Drexel University
Philadelphia, Pennsylvania, United States, 19139
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here