About this trial
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 criteria
Qualifiers
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
Disqualifiers
Are unable to fluently speak, write and read English.
Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment from another provider)
Are receiving weight loss treatment (behavioral or pharmacological)
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,)
Trial design
Treatments tested in this trial
- Digital
Treatment groups
Sponsors and collaborators
Drexel University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Oui Therapeutics, Inc.
Collaborator