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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)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 15, 2026 → Dec 31, 2026
Primary endpoint removed 6 → 5 primary endpoints
Enrollment reduced 44% 144 → 80 participants
See other at-risk trials from University of Minnesota

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified
    • Enrollment reduced: 144 → 80 participants
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints expanded, about 2 words
  2. Minor Primary and study completion pushed from Jul 15, 2026 to Dec 31, 2026v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
  5. Minor Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Nov 25, 2024 to Jan 15, 2025
    • Primary and study completion dates: May 15, 2026 to Jul 15, 2026
    v4
  2. Notable Start date: Oct 15, 2024 to Nov 25, 2024
    • Primary and study completion dates: Apr 15, 2026 to May 15, 2026
    v3
  3. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 participants' EMA-reported interoception scores during the intervention period that fall 1 SD or more above their baseline EMA-reported interoception levels.
Trial Details
NCT Number NCT06631729
Lead Sponsor University of Minnesota
Conditions
(from sponsor)
Eating Disorders
Related terms Feeding and Eating Disorders
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov