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NCT04162574 · ClinicalTrials.gov registry record
Binge-Eating Genetics Initiative (BEGIN) - Dynamical Systems Approach
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 1,166
- Enrollment target
NCT04162574: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT04162574 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 1,166 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04162574 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 1,166 participants
- Enrollment target
Study Summary
The Binge Eating Genetics Initiative (BEGIN) is an observational study where individuals with binge-eating disorder (BED) or bulimia nervosa (BN) complete assessments about eating disorder history, current disordered eating behavior, and mood. Participants also provide active data on binge eating, purging, nutrition, and cognitions using Recovery Record on the Apple Watch. Passive sensor data are collected via native applications over a 30-day period in 1000 individuals with BED or BN. Investigators will combine longitudinal passive (Apple Watch) and active (Recovery Record) data to predict when patients are at high risk of binge eating or purging. Results will enable the deployment of real-time, in-the-moment, personalized signaling of impending binge or purge episodes that will interrupt automatic behaviors and empower patients to exert control over binge eating and purging by engaging in therapeutic alternatives.
Primary Outcome
Dynamic systems approach will use passive and active data to illustrate the dynamics that lead up to a binge or purge event. Using passive data up to two hours prior to a binge or purge event as recorded within the Recovery Record app by the participant (but not within an hour of a previous event), changes in heart rate and actigraphy will be modeled as a function of current heart rate and actigraphy. Time leading up to the binge or purge event, type of event (binge or purge), and an interaction
Interventions
- OTHER Recovery Record
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,166 participants |
| Start Date | 2017-08-24 |
| Est. Completion | 2021-08-31 |
What the finished NCT04162574 record still lists
NCT04162574 is an observational study that tracks outcomes without assigning an intervention. Its 1,166 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Recovery Record is the first listed.
NCT04162574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04162574 about?
NCT04162574 is a clinical study titled "Binge-Eating Genetics Initiative (BEGIN) - Dynamical Systems Approach". The Binge Eating Genetics Initiative (BEGIN) is an observational study where individuals with binge-eating disorder (BED) or bulimia nervosa (BN) complete assessments about eating disorder history, current disordered eating behavior, and mood. Participants also provide active data on binge eating, p...
What is the current status of trial NCT04162574?
This trial is currently completed. The enrollment target is 1,166 participants. The study started on 2017-08-24. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT04162574?
The interventions under investigation include: Recovery Record (OTHER).
Who is sponsoring clinical trial NCT04162574?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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