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The Bio-HEALTH Study: Understanding Binge-Spectrum Eating Disorders

This study, called the Bio-HEALTH Study, is looking for adults aged 18-64 with binge-spectrum eating disorders. It aims to understand how two behavioral interventions, HRV-bio and ED-JITAI, affect binge eating and purging behaviors, as well as heart rate variability (HRV). HRV-bio teaches you to improve your heart rate variability using an app-guided breathing exercise. ED-JITAI involves short, guided body scan videos sent to your phone. The study will measure changes in momentary binge eating, purging behaviors, and heart rate variability over 5 weeks. You cannot have had recent changes to your eating disorder treatment or be pregnant or breastfeeding to participate. The study is fully remote.

Study design
This is an interventional study with a planned enrollment of 144 participants. It includes observational assessments and a clinical trial.
What's involved
You will complete surveys on your mobile device 6 times a day for 7 days during a baseline period and wear a chest-worn heart monitor. You will also participate in one of two behavioral interventions.
Compensation
Not stated in the trial record.
Follow-up
Primary endpoints are measured at baseline and 5 weeks.

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NCT06631729

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)

Recruiting
NAAges 18–64InterventionalBasic science
University of Minnesota
~144 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:HRV-bioED-JITAI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Momentary binge eating
Measured over baseline, 5 weeks
+5 more outcomes measured

Conditions

Eating Disorders

Explore related trials

Binge EatingBulimia Nervosa

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Carol Peterson, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Kelly Romano, PhD
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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.

What this trial measures

  • Momentary binge eatingbaseline, 5 weeks

    "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 behaviorsbaseline, 5 weeks

    "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.

  • Heartrate variabilitybaseline, 5 weeks

    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.

  • Momentary self-reported interoceptive sensibilitybaseline, 5 weeks

    "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 Compliancebaseline, 5 weeks

    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).

  • Attritionbaseline, 5 weeks

    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.