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NCT06631729 · ClinicalTrials.gov registry record · NA
Targeting Transdiagnostic Self-regulatory Factors and Eating Disorder Pathology Among Adults With BInge-spectrum Eating disOrders: A mHEALTH Interoceptive Exposure Intervention (the Bio-HEALTH Study)
A NA study of Eating Disorders, sponsored by University of Minnesota.
- Recruiting
- Registry status
- NA
- Development phase
- 144
- Enrollment target
- 1
- Study location
NCT06631729 is a NA study of Eating Disorders that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 144 participants, below the 319-participant average among 37 other Eating Disorders trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06631729, a NA study of Eating Disorders, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
- 1
- Study location
Study Summary
The present study will be fully remote (virtual) and include observational design features (assessments) plus a clinical trial. All assessments will be completed using HIPAA-approved platforms (e.g., Qualtrics, MindLogger EMA platform). After screening via Qualtrics to determine eligibility (described below), participants will complete a cross-sectional survey via Qualtrics, followed by a baseline EMA period. During the baseline EMA period, participants will receive brief (3-5 minutes) surveys on their mobile devices 6 times per day for 7-days via the MindLogger app. During the baseline EMA period, participants will also be asked to wear non-invasive chest-worn Holter monitors (Polar H10 Holter monitors) that will capture their heartrate variability data. They will then complete the 4-week intervention (HRV bio or ED-JITAI treatment arms; see below), followed by a post-intervention 7-day EMA assessment period while they also wear the Holter monitors. Recruitment is expected to last for 1.5 years. In HRV-bio, participants will also complete a HRV biofeedback task via the Elite HRV app. In this intervention, participants will learn how to use their HRV data that they will see in real-time via the Elite HRV app to improve their HRV by engaging in an app-guided diaphragmatic breathing exercise. They will complete this exercise twice daily (morning, night). In ED-JITAI, participants will be prompted to complete focused, guided body scan tasks that will be sent to them via the MindLogger app. These guided tasks will be sent to them in the form of 1 of 3 brief (3-5 minute) videos via the MindLogger app. The body scans will be designed to promote participants' connection with, vs. distancing/distraction from, feared ED sensations (e.g., hunger, satiety, bloating). Participants will receive prompts to complete the body scans at times when they report via EMA that they are experiencing worse interoception than usual. "Worse interoception than usual" will be defined as part
Conditions Studied
Interventions
- BEHAVIORAL HRV-bio
- BEHAVIORAL ED-JITAI
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2025-01-15 |
| Est. Completion | 2026-07-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06631729
The ClinicalTrials.gov registry entry for NCT06631729 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 319-participant average among 37 other Eating Disorders trials with a reported enrollment target (55% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Eating Disorders appearing as the primary indexed condition, and to 2 interventions - of which HRV-bio is the first listed.
NCT06631729 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06631729 about?
NCT06631729 is a clinical study titled "Targeting Transdiagnostic Self-regulatory Factors and Eating Disorder Pathology Among Adults With BInge-spectrum Eating disOrders: A mHEALTH Interoceptive Exposure Intervention (the Bio-HEALTH Study)". The present study will be fully remote (virtual) and include observational design features (assessments) plus a clinical trial. All assessments will be completed using HIPAA-approved platforms (e.g., Qualtrics, MindLogger EMA platform). After screening via Qualtrics to determine eligibility (describ...
What is the current status of trial NCT06631729?
This trial is currently recruiting. It is a NA study. The enrollment target is 144 participants. The study started on 2025-01-15. Estimated completion is 2026-07-15.
What conditions does trial NCT06631729 study?
This clinical trial studies the following conditions: Eating Disorders.
What interventions are being tested in trial NCT06631729?
The interventions under investigation include: HRV-bio (BEHAVIORAL), ED-JITAI (BEHAVIORAL).
Who is sponsoring clinical trial NCT06631729?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06631729 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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