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
Exclusion Criteria:
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, Icf
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical College of Wisconsin