Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy (MINDBP)

Medical College of Wisconsin

Status: Begins enrollment this month

Conditions: Preeclampsia

Treatments: Behavioral: Garmin Vivoactive 4 watch; Behavioral: Mindfulness training

Study type: Interventional

Funder types: Other

Identifiers

NCT07218237

PRO00056473

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

MT + Biofeedback

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness training

Behavioral: Garmin Vivoactive 4 watch

MT

Experimental group

Description:

Mindfulness training (no access to wearable biosensor data)

Treatment:

Behavioral: Mindfulness training

Control

No Intervention group

Description:

Routine prenatal care alone