NCT06454123

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 6, 2024

Last Update Submit

June 6, 2024

Conditions

Binge EatingObesity

Outcome Measures

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.

    Week 12

Study Arms (1)

Treatment

EXPERIMENTAL
Device: OTX-401

Interventions

OTX-401DEVICE

Evidence-based treatments for obesity and binge eating

Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BulimiaObesity

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Central Study Contacts

Brian Keenaghan

CONTACT

2037254024brian@ouitherapeutics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 12, 2024

Study Start

September 1, 2024

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

June 12, 2024

Record last verified: 2024-06