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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOui Therapeutics, Inc.

About this trial

The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • OTX-401

    Device

    Evidence-based treatments for obesity and binge eating

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

System Usability Sale (SUS)

The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability.

Time frame
Week 12

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oui Therapeutics, Inc.

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: