Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Medical College of Wisconsin
Study ID
NCT07218237
Status
Not Yet Recruiting

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Conditions

  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Sep 2025
Primary completion
Mar 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: MT + Biofeedback
    Mindfulness training plus self-monitoring with access to data from wearable biosensor
  • Experimental: MT
    Mindfulness training (no access to wearable biosensor data)
  • No Intervention: Control
    Routine prenatal care alone

Primary Outcome Measure

Feasibility of multisite RCT [ Time Frame: 3 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brown UniversityProvidenceRhode Island02904
Margaret Bublitz, PhD
[email protected]
401-793-7884
Medical College of WisconsinMilwaukeeWisconsin53226
Anna Palatnik, MD
[email protected]
14148056627
Alyssa Hernandez, DO
[email protected]
4149552781

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