An interventional study of HRV-bio and ED-JITAI in Eating Disorders, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science
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Among 259 studies in Feeding and Eating Disorders with a site in United States — 36 open to participants now, 50 under way, none of them phase 3. Feeding and Eating Disorders · United States.
Among the 259 studies in Feeding and Eating Disorders with a site in United States, this one is the 88th largest by planned enrollment of the 215 interventional ones that give a count, is one of 12 that started in 2025, is one of 169 with no phase, reaches primary completion later than 10 of the 49 other live ones, and was the 231st registered.
645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.
Browse Feeding and Eating Disorders studies →36 of the 259 studies in Feeding and Eating Disorders with a site in United States are open now. Recruiting first, the newest first:
Medical University of South Carolina · Sites in United States
Ages up to 6 mo
Duke University · Sites in United States
Ages 15–25
Duke University · Sites in United States
Ages 18–25
Washington University School of Medicine · Sites in United States
Ages 18+
Trustees of Dartmouth College · Sites in United States
Ages 18–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 100 Feeding and Eating Disorders studies recruiting now, 31 (31%) set no upper age limit and 67 (67%) stop at 75 or younger; 45 take children under 18; 20 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · no healthy volunteers.
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259 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 19 · Phase 3 7 · Phase 4 6
First in 1995; this study’s year is marked. 12 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 71 across 452 interventional studies indexed under Feeding and Eating Disorders.
Median enrollment 66 across the 215 interventional studies, 90 across the 43 observational. Of the 200 that completed or were terminated, 49 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 259 have an industry lead sponsor. The 10 most frequent:
University of Minnesota is the lead sponsor of 1,217 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
University of Minnesota has 5 studies filed under Feeding and Eating Disorders — fewer than ten, so there is no comparison to draw.
29 of the studies in Feeding and Eating Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858774Icahn School of Medicine at Mount SinaiUse of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients With Binge Eating Disorder | 2026-11 |
| NCT06532734Denver Health and Hospital AuthorityBarrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype | 2026-11 |
| NCT07740291Texas Tech UniversityTirzepatide Impact Assessment Study | 2026-11-23 |
| NCT05509257Children's Mercy Hospital Kansas CityNaltrexone Neuroimaging in Teens With Eating Disorders | 2026-12 |
| NCT07589621Florida State UniversitySafety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns | 2026-12 |
Add all 29 to your calendar (.ics) → With an account.
Among the 259 studies in Feeding and Eating Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
randomized to HRV bio
Behavioral: HRV-bio
Randomized to ED-JITAI treatment
Behavioral: ED-JITAI
participants will 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).
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.
Momentary binge eating
"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.
Time frame: baseline through week 6 of the study
Momentary purging behaviors
"Momentary purging behaviors" include the following behaviors that individuals may engage in at a given moment as maladaptive attempts of preventing weight gain or losing weight: self-induced vomiting; maladaptive use of laxatives; maladaptive use of diuretics; fasting (e.g., no food for \>8 hours, skipping meals); excessive exercise. These behaviors will be assessed at the momentary (or state) level of analysis using ecological momentary assessment.
Time frame: baseline through week 6 of the study
Momentary self-reported interoceptive sensibility
"Momentary self-reported interoceptive sensibility" is operationalized as individuals' subjective (selfreported) perceptions of their ability to sense and connect with their internal body sensations at a given moment, such as hunger, satiety, heartbeat, pain, bloating, etc. This construct will be assessed at the momentary (or state) level of analysis using ecological momentary assessment.
Time frame: baseline through week 6 of the study
Treatment Compliance
For participants in the HRV-bio intervention arm, treatment compliance is operationalized as the number of HRV-biofeedback tasks that participants complete during the 4-week intervention period ÷ the total possible number of HRV-biofeedback tasks. For participants in the ED-JITAI intervention arm, treatment compliance is operationalized as the number of app-prompted focused body scans that participants complete during the 4-week intervention period ÷ the total possible number of focused body scans that they are prompted to complete. The total possible number of focused body scans will differ for each participant, as they will only receive prompts to complete these scans when they report via ecological momentary assessment that they are experiencing worse interoception than usual (with "usual" determined based on their personal mean interoception values that will be obtained during the pre-treatment ecological momentary assessment period).
Time frame: baseline through week 6 of the study
Attrition
Attrition is operationalized as the total number of participants who stop participating in the 4-week intervention prematurely, as evidenced by a complete cessation of engaging in the intervention tasks (HRV-biofeedback task or focused body scan prompts), or who are otherwise lost to follow-up.
Time frame: baseline through week 6 of the study
Heartrate variability
Heartrate variability is a generalized neurobiological indicator of interoception (the ability to sense and connect with one's internal bodily sensations) and autonomic nervous system functioning. It will be assessed using Holter monitors and smartwatches that capture fluctuations in the time intervals between adjacent heartbeats.
Time frame: baseline through week 6 of the study
PDFs hosted by the registry, ClinicalTrials.gov.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 269 non-industry interventional studies with no phase under Feeding and Eating Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 23 months is below that.
Counting every sponsor, half of 274 studies reached it within 28 months; a quarter within 14 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Feeding and Eating Disorders →