NCT06454123
Not Yet Recruiting
N/A
A Feasibility Study of a Digital Therapeutic for Adults With Recurrent Binge Eating and Obesity
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Binge Eating
- Sponsor
- Oui Therapeutics, Inc.
- Enrollment
- 30
- Primary Endpoint
- System Usability Sale (SUS)
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.
Detailed Description
This single-arm, open-label clinical trial will test the feasibility, usability, acceptability, and preliminary efficacy of a digital therapeutic in reducing binge eating and weight in 30 adults with comorbid recurrent binge eating and obesity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •English speaking male or female patients, 18-70 years
- •Patients with recurrent binge eating (≥12 episodes in 3 months) and obesity (BMI ≥30)
- •Understand written and spoken English
- •Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
- •Willing and able to complete enrollment procedures
- •Able to understand the nature of the study and provide written informed consent
Exclusion Criteria
- •Patients with active psychosis
- •Patients who are acutely intoxicated at the time of enrollment
- •Currently enrolled in other treatment studies for the symptoms and behaviors targeted
- •Patients who are cognitively impaired
- •Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the digital therapeutic
Outcomes
Primary Outcomes
System Usability Sale (SUS)
Time Frame: Week 12
The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability.
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