Eating DisordersNCT06631729
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 study testing HRV-bio and ED-JITAI in people with Eating Disorders, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- HRV-bio and ED-JITAI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ages 18-64;
- no changes to ED treatment in the past 4-weeks;
- agree not to access other eating disorder treatments throughout the studies (unless warranted by a worsening of participants' symptoms during the study period; see Monitoring Participant Safety for more information);
- no bariatric surgery (prior or planned during the study period);
- no pregnancy or lactation (current or planned during the study);
- own an Apple or Android-brand iOS smartphone (which is required for compatibility with the apps used in this study;
- reside in the continental U.S.;
- meet Diagnostic and Statistical Manual of Mental Disorders-5-TR (DSM-5-TR) criteria for binge eating disorder (BED) or bulimia nervosa (BN), both of which include objective binge eating (i.e., consuming a larger amount of food than most people would eat in a similar period of time under similar circumstances with loss of control over eating during the episode) ≥1x/week over the past 3 months (APA, 2022). Single-item questions will determine eligibility via criteria 1-7. Criterion 8 for will be determined via the Eating Disorder Diagnostic Scale for the DSM-5 (EDDS-5; Stice et al., 2000, 2004), which has exhibited good sensitivity (.88), specificity (.98), and positive predictive power (.74) for detecting EDs among community samples (Stice et al., 2000, 2004).
Who cannot join
- not between the ages of 18 and 64;
- had changes to ED treatment in the past 4 weeks;
- plan to access other eating disorder treatments throughout the study;
- received or are planning to undergo bariatric surgery during the study period;
- currently pregnant or lactating, or planning to become pregnant or lactate during the study period;
- no Apple or Android-brand iOS smartphone;
- do not live in the continental U.S.;
- do not currently experience BN or BED.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Romano, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Kelly Romano, kromano@umn.edu
About this 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 (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.
Read more
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.
- Conditions
- Eating Disorders
- Being tested
- HRV-bio, ED-JITAI
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV-bioBehavioural
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).
ED-JITAIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | randomized to HRV bio Receives: Behavioral: HRV-bio |
| Group 2 | Experimental | Randomized to ED-JITAI treatment Receives: Behavioral: ED-JITAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline through week 6 of the study
Secondary outcomes (1)
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.
Measured: baseline through week 6 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol Peterson, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631729
- Sponsor's protocol ID
- the Bio-HEALTH Study
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06631729
- Acronym / sponsor ID
- the Bio-HEALTH Study
- Conditions
- Eating Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: HRV-biorandomized to HRV bio |
| Group 2 | Experimental | Behavioral: ED-JITAIRandomized to ED-JITAI treatment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- ages 18-64;
- no changes to ED treatment in the past 4-weeks;
- agree not to access other eating disorder treatments throughout the studies (unless warranted by a worsening of participants' symptoms during the study period; see Monitoring Participant Safety for more information);
- no bariatric surgery (prior or planned during the study period);
- no pregnancy or lactation (current or planned during the study);
Key exclusion criteria (8 listed)
- not between the ages of 18 and 64;
- had changes to ED treatment in the past 4 weeks;
- plan to access other eating disorder treatments throughout the study;
- received or are planning to undergo bariatric surgery during the study period;
- currently pregnant or lactating, or planning to become pregnant or lactate during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV-bioparticipants 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). | Behavioural | Group 1 |
| ED-JITAIparticipants 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. | Behavioural | Group 2 |
Primary outcome
Momentary binge eating
Time frame: baseline through week 6 of the study
"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.
Momentary purging behaviors
Time frame: baseline through week 6 of the study
"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.
Momentary self-reported interoceptive sensibility
Time frame: baseline through week 6 of the study
"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.
Treatment Compliance
Time frame: baseline through week 6 of the study
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).
Attrition
Time frame: baseline through week 6 of the study
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.
1 secondary outcome
Heartrate variability
Time frame: baseline through week 6 of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Romano, PhD contact
Carol Peterson, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV-bio and ED-JITAI in people with Eating Disorders, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Romano, PhD (kromano@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Momentary binge eating (time frame: baseline through week 6 of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.