NCT06817863 A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity
| NCT ID | NCT06817863 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Drexel University |
| Condition | Binge Eating Disorder Associated With Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-02 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Are English speaking male or female 2. Are aged 18-70 years 3. Have recurrent objective or subjective binge eating episodes (≥12 episodes in 3 months) 4. Have BMI ≥30 5. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher 6. Are willing and able to complete enrollment procedures 7. Are able to understand the nature of the study and provide written informed consent Exclusion Criteria: 1. Are unable to fluently speak, write and read English. 2. Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment from another provider) 3. Are receiving weight loss treatment (behavioral or pharmacological) 4. 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,) 5. Are purging and/or using laxatives 3 or more times per week and are not deemed safe for remote treatment by a primary care provider. 6. Are exercising 2 or more hours a day on average, or engaging in significantly harmful compensatory behaviors (i.e., \> 3x/week of self-induced vomiting or laxative use), and are not deemed safe for remote treatment by a primary care provider. 7. Are fasting for 24 hours or more, \> 3x times a week, and are not deemed safe for remote treatment by a primary care provider. 8. Are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate. 9. Are pregnant or planning to become pregnant within the next year. 10. Are individuals who are not yet adults (infants, children, teenagers) Are currently taking any of these medications: Haldol, Loxitane, Mellaril, Moban, Navane, Prolixin, Serentil, Stelaxine, Trilafon, Thoraxine, Abilify, Clozaril, Geodon, Risperdal, Seroquel, Zyprexa 11. Are adults unable to consent 12. Are prisoners
Frequently Asked Questions
Who can join the NCT06817863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Binge Eating Disorder Associated With Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06817863 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06817863 currently recruiting?
Yes, NCT06817863 is actively recruiting participants. Visit ClinicalTrials.gov or contact Drexel University to inquire about joining.
Where is the NCT06817863 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06817863 clinical trial?
NCT06817863 is sponsored by Drexel University. The trial plans to enroll 30 participants.
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