Technology Assisted Treatment for Binge Eating Behavior

NCT ID: NCT05829941

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-08-31

Brief Summary

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.

Conditions

Binge-Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

HabitAware condition

This group will receive the device which messages the participant after a passively detected binge-eating episode with CBT strategies.

Group Type: EXPERIMENTAL

Smartwatch app to deliver binge-eating CBT strategies

Intervention Type: BEHAVIORAL

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.

Reminder Condition

This group will receive a device that vibrates randomly throughout the day as a reminder not to binge eat.

Group Type: PLACEBO_COMPARATOR

Reminder control condition

Intervention Type: BEHAVIORAL

Participants will receive a smartwatch that vibrates randomly, and will be instructed the vibration is a cue not to binge eat.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

HabitAware Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sameer Kumar, BS

Role: CONTACT

sameer@habitaware.com

2489904720

Other Identifiers

132180

Identifier Type: -

Identifier Source: org_study_id