Digital Intervention for Binge Eating
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you do not take certain medications, including Haldol, Loxitane, Mellaril, Moban, Navane, Prolixin, Serentil, Stelaxine, Trilafon, Thoraxine, Abilify, Clozaril, Geodon, Risperdal, Seroquel, and Zyprexa. If you are taking any of these, you would need to stop before participating.
What data supports the effectiveness of the treatment ChangeBite for binge eating?
Research shows that digital interventions based on cognitive-behavioral therapy (CBT) principles, similar to ChangeBite, have been effective in reducing binge eating episodes and improving related symptoms. These interventions are well-received by patients and maintain positive results over time.12345
Is the digital intervention for binge eating safe for humans?
How is the treatment ChangeBite different from other treatments for binge eating?
What is the purpose of 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
This trial is for adults with obesity and binge eating behavior. Participants will be recruited in Philadelphia and must be willing to use the ChangeBite digital intervention, attend video call assessments, and provide weekly weight updates via photos. Individuals not meeting these requirements or unable to consent won't qualify.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage with the ChangeBite digital intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ChangeBite
Find a Clinic Near You
Who Is Running the Clinical Trial?
Drexel University
Lead Sponsor
Oui Therapeutics, Inc.
Industry Sponsor
National Institute of Mental Health (NIMH)
Collaborator