Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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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

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

All participants will wear a Garmin Vivoactive 4 biosensor watch throughout the study. However, only one of the arms will have real-time access to thier data, while the other 2 arms will be masked to their watch data. The study team will have access to the watch data for all 3 arms.

Study Groups

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MT + Biofeedback

Mindfulness training plus self-monitoring with access to data from wearable biosensor

Group Type EXPERIMENTAL

Mindfulness training

Intervention Type BEHAVIORAL

Mindfulness training with trained instructors

Garmin Vivoactive 4 watch

Intervention Type BEHAVIORAL

Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.

MT

Mindfulness training (no access to wearable biosensor data)

Group Type EXPERIMENTAL

Mindfulness training

Intervention Type BEHAVIORAL

Mindfulness training with trained instructors

Control

Routine prenatal care alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness training

Mindfulness training with trained instructors

Intervention Type BEHAVIORAL

Garmin Vivoactive 4 watch

Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No