Obesity Clinical Trial
Official title:
A Feasibility Study of a Digital Therapeutic for Adults With Recurrent Binge Eating and Obesity
The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | June 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. English speaking male or female patients, 18-70 years 2. Patients with recurrent binge eating (=12 episodes in 3 months) and obesity (BMI =30) 3. Understand written and spoken English 4. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher 5. Willing and able to complete enrollment procedures 6. Able to understand the nature of the study and provide written informed consent Exclusion Criteria: 1. Patients with active psychosis 2. Patients who are acutely intoxicated at the time of enrollment 3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted 4. Patients who are cognitively impaired 5. Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the digital therapeutic |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Oui Therapeutics, Inc. | National Institute of Mental Health (NIMH) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | System Usability Sale (SUS) | The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability. | Week 12 |
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