Technology Assisted Treatment for Binge Eating Behavior

Binge-Eating Disorder Clinical Trial

Official title:

Technology Assisted Treatment for Binge Eating Behavior

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05829941
• Other study ID #: 132180
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2023
• Source: HabitAware Inc.
• Contact: Sameer Kumar, BS
• Phone: 2489904720
• Email: sameer[@]habitaware.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Behavioral:
• 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.
• Reminder control condition
Participants will receive a smartwatch that vibrates randomly, and will be instructed the vibration is a cue not to binge eat.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
HabitAware Inc.	University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in the HabitAware condition that report the treatment is acceptable.	Measured via post-treatment survey	8 weeks
Secondary	Percentage of patients report that the binge episode detection is accurate	Measured via post-treatment survey	8 weeks