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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Rhode Island
Brown University
RECRUITING
Providence
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Anna Palatnik, MD
apalatnik@mcw.edu
14148056627
Backup
Alyssa Hernandez, DO
alyhernandez@mcw.edu
4149552781
Time Frame
Start Date: 2026-04-28
Estimated Completion Date: 2028-10
Participants
Target number of participants: 90
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov