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NCT04126694 · ClinicalTrials.gov registry record · NA
Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
A NA study of Bulimia Nervosa and Binge Eating, sponsored by Drexel University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04126694: Completed NA study of Bulimia Nervosa and Binge Eating, sponsored by Drexel University.
NCT04126694 is a NA study of Bulimia Nervosa and Binge Eating that has completed, run by Drexel University. The registered enrollment target is 30 participants, below the 1,737-participant average among 23 other Bulimia Nervosa trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04126694, a NA study of Bulimia Nervosa and Binge Eating, has completed, sponsored by Drexel University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The current study will be one of the first to develop and test a passive data collection technique to detect both meal consumption and disordered eating symptoms in patients with clinically significant binge eating and the first just-in-time adaptive interventions (JITAIs) systems using passive sensing technology for eating pathology to be empirically evaluated. A small iterative open clinical trial using an ABAB design (A= SenseSupport Off, B=SenseSupport On) will be conducted to test the feasibility, acceptability, and target engagement of SenseSupport when paired with a 12 week in-person CBT treatment program. The hypothesis that larger decreases in dietary restriction will be observed during SenseSupport On phases compared to SenseSupport Off phases will be tested in this clinical trial.
Primary Outcome
The number of weekly episodes of going ≥ 4 waking hours without eating captured through CGM and EMA data as well as an EDE-Q assessment before each weekly therapy session. Higher numbers indicate more weekly episodes of dietary restriction. There are no subscale scores or a total score. The number of weekly episodes of going ≥ 4 waking hours without eating will be used to assess the amount of dietary restriction occurring throughout the course of treatment as compared to baseline dietary restric
Conditions Studied
Interventions
- BEHAVIORAL CBT with smartphone application SenseSupport
Study Locations (1)
Pennsylvania
- Drexel University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2021-08-01 |
| Phase | NA |
What the finished NCT04126694 record still lists
NCT04126694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,737-participant average among 23 other Bulimia Nervosa trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Bulimia Nervosa appearing as the primary indexed condition, and to 1 intervention - of which CBT with smartphone application SenseSupport is the first listed.
NCT04126694 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04126694 about?
NCT04126694 is a clinical study titled "Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology". The current study will be one of the first to develop and test a passive data collection technique to detect both meal consumption and disordered eating symptoms in patients with clinically significant binge eating and the first just-in-time adaptive interventions (JITAIs) systems using passive sens...
What is the current status of trial NCT04126694?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2020-07-06. Estimated completion is 2021-08-01.
What conditions does trial NCT04126694 study?
This clinical trial studies the following conditions: Bulimia Nervosa, Binge Eating.
What interventions are being tested in trial NCT04126694?
The interventions under investigation include: CBT with smartphone application SenseSupport (BEHAVIORAL).
Who is sponsoring clinical trial NCT04126694?
This trial is sponsored by Drexel University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04126694 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04126694's enrollment target sits among peer trials
30 17th of 23 higher than 6 of 23 other Bulimia Nervosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bulimia Nervosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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