Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity

Obesity Clinical Trial

Official title:

A Feasibility Study of a Digital Therapeutic for Adults With Recurrent Binge Eating and Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454123
• Other study ID #: 2023-Oui-001
• Secondary ID: 1R41MH134704-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Oui Therapeutics, Inc.
• Contact: Brian Keenaghan
• Phone: 2037254024
• Email: brian[@]ouitherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Obesity

Intervention

Device:
• OTX-401
Evidence-based treatments for obesity and binge eating

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oui Therapeutics, Inc.	National Institute of Mental Health (NIMH)

Outcome

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