NCT07218237

Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Preeclampsia

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness training	Mindfulness training with trained instructors
BEHAVIORAL	Garmin Vivoactive 4 watch	Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-10-01
• First posted: 2025-10-20
• Last updated: 2025-10-20

Locations

2 sites across 1 country: United States