An interventional study of Mindfulness training and Garmin Vivoactive 4 watch in Preeclampsia, sponsored by Medical College of Wisconsin. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Prevention
The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) mindfulness training (MT) plus wearable biosensors, (2) MT alone, or (3) routine prenatal care. MT participants will receive 8 weekly phone-based MT sessions plus two booster sessions at 1 and 2 months post-intervention. The primary outcome is study feasibility.
The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) MT + wearable biosensors, (2) MT alone, or (3) routine prenatal care. MT participants will receive 8 weekly phone-based MT sessions plus two booster sessions at 1 and 2 months post-intervention. All participants will wear Garmin Vivoactive 4 watches. Blood pressure, heart rate, heart rate variability, perceived stress, and pregnancy-related anxiety will be assessed at baseline (≤16 weeks), post-intervention (\~24 weeks), and after each booster (\~28 and 32 weeks). Feasibility, fidelity, and acceptability outcomes will be assessed after each post-intervention
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 90 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mindfulness training plus self-monitoring with access to data from wearable biosensor
Behavioral: Mindfulness training · Behavioral: Garmin Vivoactive 4 watch
Mindfulness training (no access to wearable biosensor data)
Behavioral: Mindfulness training
Routine prenatal care alone
Mindfulness training with trained instructors
Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.
Feasibility of multisite RCT
Assess study feasibility as measured by retention rate
Time frame: 3 years
Acceptability of MINDBP intervention
Assess intervention acceptability using Theoretical Framework of Acceptability Questionns (TFAQ). The TFAQ include 8 Likert-scale items which are averaged to provide an overall score from 1-5, with 5 indicating higher acceptability.
Time frame: Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training intervention.
Home blood pressure
Average systolic and diastolic blood pressure measured using home blood pressure monitoring
Time frame: Daily blood pressure measurements for 6 weeks throughout the study
Heart rate variability
Average daily stress score based on heart rate variability from biosensor watch
Time frame: Up to 34 weeks
Perceived stress
Self-reported perceived stress using the Perceived Stress Scale, which is scored from 0-40, with higher scores indicating higher perceived stress.
Time frame: Measured at baseline and 2, 3, and 4 months after consent.
Pregnancy-related anxiety
Self-reported pregnancy-related anxiety using the PRAQ-R2, which is cored from 0-40, with higher scores indicating higher anxiety.
Time frame: Measured at baseline and 2, 3, and 4 months after consent.
Plan to share: Yes — Data collected in the study will include information collected from participants during pregnancy and up to 6 weeks postpartum. Variables will include demographic information, participant-reported survey data, wearable biosensor data, and maternal blood pressure from n=90 participants. All data will be de-identified prior to data sharing.
Supporting information: Study protocol, Informed consent form
Time frame: The repository will make the data accessible within 2 years of the last patient's last study visit or at the end of the performance period, or no later than the date of publication, whichever is sooner. Data will be preserved within the repositories for at least three years following the completion of the grant, as required by federal retention guidelines.
Access criteria: Data that are necessary for and of sufficient quality to validate and replicate the study findings for the primary aims will be shared. We agree that the data will be deposited and made available as public use data to the research community via BioLINCC, and that these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. We agree that the names and institutions of persons either given or denied access to the data, and the basis for such decisions, will be summarized in the annual progress report. Interested investigators will need to seek approval for data access from the contact PI.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Mar 2028, 23 months after the start.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 23 months is close to that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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