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

June 6, 2024 updated by: Oui Therapeutics, Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Device: OTX-401
Evidence-based treatments for obesity and binge eating

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oui Therapeutics, Inc.

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-Oui-001
  • 1R41MH134704-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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