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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
90
Mindfulness training with trained instructors
Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.
Brown University
Providence, Rhode Island, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
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.
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