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NCT07218237NARecruiting

Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

Medical College of Wisconsin

Start Date

4/28/2026

Completion Date

10/1/2028

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

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

BEHAVIORAL

Mindfulness training

BEHAVIORAL

Garmin Vivoactive 4 watch

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Conditions

Preeclampsia

Locations

Brown University

Providence, Rhode Island 02904

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States