Technology Assisted Treatment for Binge Eating Behavior
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedApril 28, 2023
April 1, 2023
6 months
April 13, 2023
April 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients in the HabitAware condition that report the treatment is acceptable.
Measured via post-treatment survey
8 weeks
Secondary Outcomes (1)
Percentage of patients report that the binge episode detection is accurate
8 weeks
Study Arms (2)
HabitAware condition
EXPERIMENTALThis group will receive the device which messages the participant after a passively detected binge-eating episode with CBT strategies.
Reminder Condition
PLACEBO COMPARATORThis group will receive a device that vibrates randomly throughout the day as a reminder not to binge eat.
Interventions
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.
Participants will receive a smartwatch that vibrates randomly, and will be instructed the vibration is a cue not to binge eat.
Eligibility Criteria
You may qualify if:
- Adults ≥18 years of age
- EDE diagnosis of bulimia nervosa or binge eating disorder, with binge-eating episodes occurring at least 2x/week
You may not qualify if:
- Pregnancy or lactation
- Acute medical or psychiatric risk
- Psychosis or bipolar disorder (lifetime history)
- Current substance use disorder within the past six months
- BMI less than 18.5 kg/m2
- Acute suicidality requiring hospitalization
- Food allergies
- Receiving current psychotherapy
- On psychotropic medications that have not been on a stable dose for at least six weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HabitAware Inc.lead
- University of Minnesotacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2023
First Posted
April 26, 2023
Study Start
December 1, 2024
Primary Completion
June 1, 2025
Study Completion
August 1, 2025
Last Updated
April 28, 2023
Record last verified: 2023-04