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Technology Assisted Treatment for Binge Eating Behavior

Primary Purpose

Binge-Eating Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smartwatch app to deliver binge-eating CBT strategies
Reminder control condition
Sponsored by
HabitAware Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    HabitAware condition

    Reminder Condition

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Percentage of patients in the HabitAware condition that report the treatment is acceptable.
    Measured via post-treatment survey

    Secondary Outcome Measures

    Percentage of patients report that the binge episode detection is accurate
    Measured via post-treatment survey

    Full Information

    First Posted
    April 13, 2023
    Last Updated
    April 27, 2023
    Sponsor
    HabitAware Inc.
    Collaborators
    University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05829941
    Brief Title
    Technology Assisted Treatment for Binge Eating Behavior
    Official Title
    Technology Assisted Treatment for Binge Eating Behavior
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2024 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    HabitAware Inc.
    Collaborators
    University of Minnesota

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Binge-Eating Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HabitAware condition
    Arm Type
    Experimental
    Arm Description
    This group will receive the device which messages the participant after a passively detected binge-eating episode with CBT strategies.
    Arm Title
    Reminder Condition
    Arm Type
    Placebo Comparator
    Arm Description
    This group will receive a device that vibrates randomly throughout the day as a reminder not to binge eat.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Smartwatch app to deliver binge-eating CBT strategies
    Intervention Description
    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
    Intervention Name(s)
    Reminder control condition
    Intervention Description
    Participants will receive a smartwatch that vibrates randomly, and will be instructed the vibration is a cue not to binge eat.
    Primary Outcome Measure Information:
    Title
    Percentage of patients in the HabitAware condition that report the treatment is acceptable.
    Description
    Measured via post-treatment survey
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of patients report that the binge episode detection is accurate
    Description
    Measured via post-treatment survey
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults ≥18 years of age EDE diagnosis of bulimia nervosa or binge eating disorder, with binge-eating episodes occurring at least 2x/week Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sameer Kumar, BS
    Phone
    2489904720
    Email
    sameer@habitaware.com

    12. IPD Sharing Statement

    Learn more about this trial

    Technology Assisted Treatment for Binge Eating Behavior

    We'll reach out to this number within 24 hrs