Technology Assisted Treatment for Binge Eating Behavior

Study Overview
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Brief Summary
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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.

Official Title
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Technology Assisted Treatment for Binge Eating Behavior

Conditions
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Binge-Eating Disorder

Intervention / Treatment
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* Behavioral: Smartwatch app to deliver binge-eating CBT strategies
* Behavioral: Reminder control condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HabitAware condition<br>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<br>* 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.<br>|
| Placebo Comparator: Reminder Condition<br>This group will receive a device that vibrates randomly throughout the day as a reminder not to binge eat. | Behavioral: Reminder control condition<br>* Participants will receive a smartwatch that vibrates randomly, and will be instructed the vibration is a cue not to binge eat.<br>|

What is the study measuring?
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Primary Outcome Measures

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