Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

Not Applicable

Not yet recruiting

• Conditions: Preeclampsia

• Registration Number: NCT07218237
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

Detailed Description

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

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-10-15
• Last Update Submitted: 2025-10-15
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Study Start: 2026-03-01
• Primary Completion: 2028-03
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Pregnant patients at gestational age <= 16 weeks
• Live, non-anomalous gestation
• Normotensive at enrollment
• Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG/USPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy

Exclusion Criteria

• Multiple gestation
• Chronic (pregestational hypertension)
• Inability of unwillingness to provide informed consent
• Active suicidality or psychosis
• Ongoing mind-body practice (e.g., yoga, meditation, mindfulness >= once per week)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of multisite RCT	3 years	Assess study feasibility as measured by retention rate

Secondary Outcome Measures

Name	Time	Method
Acceptability of MINDBP intervention	Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training 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.
Pregnancy-related anxiety	Measured at baseline and 2, 3, and 4 months after consent.	Self-reported pregnancy-related anxiety using the PRAQ-R2, which is cored from 0-40, with higher scores indicating higher anxiety.
Home blood pressure	Daily blood pressure measurements for 6 weeks throughout the study	Average systolic and diastolic blood pressure measured using home blood pressure monitoring
Heart rate variability	Up to 34 weeks	Average daily stress score based on heart rate variability from biosensor watch
Perceived stress	Measured at baseline and 2, 3, and 4 months after consent.	Self-reported perceived stress using the Perceived Stress Scale, which is scored from 0-40, with higher scores indicating higher perceived stress.

Trial Locations

Locations (2)

Brown University; 🇺🇸 Providence, Rhode Island, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States