Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Recruiting NA study of Eating Disorders, sponsored by University of Minnesota.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

"Momentary binge eating" is operationalized as an eating episode in which participants report that they consumed an unusually large amount of food, given the circumstances, while also experiencing a loss of control over their eating at that time. This construct will be assessed at the momentary (or state) level of analysis using ecological momentary assessment.

Conditions Studied

Interventions

  • BEHAVIORAL HRV-bio
  • BEHAVIORAL ED-JITAI

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2025-01-15
Est. Completion 2026-07-15
Phase NA
University of Minnesota

966 total trials

What NCT06631729 shows while recruiting

NCT06631729 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 319-participant average among 37 other Eating Disorders trials with a reported enrollment target (55% lower).

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 a single indexed study location in 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.

Similar trials for Eating Disorders

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06631729's enrollment target sits among peer trials

144 13th of 37 higher than 25 of 37 other Eating Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Eating Disorders 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.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01861106 · 144 participants · Phase 2

    Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations

  • NCT03482245 · 144 participants · NA

    The Role of Circadian Clock Proteins in Innate and Adaptive Immunity

  • NCT03504683 · 144 participants · NA

    MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes

  • NCT03905603 · 144 participants · Early Phase 1

    Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT06631729, the US trial registry maintained by the National Library of Medicine. NCT06631729 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.