Technology Assisted Treatment for Binge Eating Behavior

Not Applicable

Not yet recruiting

• Conditions: Binge-Eating Disorder
• Interventions: Behavioral: Smartwatch app to deliver binge-eating CBT strategies; Behavioral: Reminder control condition

• Registration Number: NCT05829941
• Lead Sponsor: HabitAware Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-26
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28
• Study Start: 2024-12
• Primary Completion: 2025-06
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HabitAware condition	Smartwatch app to deliver binge-eating CBT strategies	This group will receive the device which messages the participant after a passively detected binge-eating episode with CBT strategies.
Reminder Condition	Reminder control condition	This group will receive a device that vibrates randomly throughout the day as a reminder not to binge eat.

Primary Outcome Measures

Name	Time	Method
Percentage of patients in the HabitAware condition that report the treatment is acceptable.	8 weeks	Measured via post-treatment survey

Secondary Outcome Measures

Name	Time	Method
Percentage of patients report that the binge episode detection is accurate	8 weeks	Measured via post-treatment survey