Technology Assisted Treatment for Binge Eating Behavior

April 27, 2023 updated by: HabitAware Inc.
Binge-eating behavior is a central feature of eating disorders (e.g., binge-eating disorder, bulimia nervosa, anorexia nervosa-binge-eating/purging subtype) and is associated with higher rates of psychopathology, psychosocial impairment, medical comorbidity, and more severe obesity, all of which pose significant public health problems. Passive detection of binge eating episodes combined with a context-based reminder intervention could assist a patient in resuming healthy eating patterns. This study will test a smartwatch app that identifies binge eating behavior and provides CBT strategies to the patient after the episode.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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. Adults ≥18 years of age
  2. EDE diagnosis of bulimia nervosa or binge eating disorder, with binge-eating episodes occurring at least 2x/week

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Acute medical or psychiatric risk
  3. Psychosis or bipolar disorder (lifetime history)
  4. Current substance use disorder within the past six months
  5. BMI less than 18.5 kg/m2
  6. Acute suicidality requiring hospitalization
  7. Food allergies
  8. Receiving current psychotherapy
  9. On psychotropic medications that have not been on a stable dose for at least six weeks

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HabitAware condition
This group will receive the device which messages the participant after a passively detected binge-eating episode with CBT strategies.
Behavioral: Smartwatch app to deliver binge-eating CBT strategies
Participants will receive a smartwatch with a pre-loaded app that will alert the participant to relevant binge-eating strategies based on their previous detected behavior.
Placebo Comparator: Reminder Condition
This group will receive a device that vibrates randomly throughout the day as a reminder not to binge eat.
Behavioral: Reminder control condition
Participants will receive a smartwatch that vibrates randomly, and will be instructed the vibration is a cue not to binge eat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients in the HabitAware condition that report the treatment is acceptable.
Time Frame: 8 weeks
Measured via post-treatment survey
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients report that the binge episode detection is accurate
Time Frame: 8 weeks
Measured via post-treatment survey
8 weeks

Collaborators and Investigators

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

Sponsor

HabitAware Inc.

Collaborators

University of Minnesota

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 (Anticipated)

December 1, 2024

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132180

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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