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NCT Number: NCT07218237

Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

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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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brown University, Providence, Rhode Island, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness Training

Behavioral

Mindfulness training with trained instructors

Garmin Vivoactive 4 watch

Behavioral

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

Primary outcomes

  1. Feasibility of multisite RCT

    Time frame: 3 years

    Assess study feasibility as measured by retention rate

Secondary outcomes

  1. Acceptability of MINDBP intervention

    Time frame: Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training 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.

  2. Home blood pressure

    Time frame: Daily blood pressure measurements for 6 weeks throughout the study

    Average systolic and diastolic blood pressure measured using home blood pressure monitoring

  3. Heart rate variability

    Time frame: Up to 34 weeks

    Average daily stress score based on heart rate variability from biosensor watch

  4. Perceived stress

    Time frame: Measured at baseline and 2, 3, and 4 months after consent.

    Self-reported perceived stress using the Perceived Stress Scale, which is scored from 0-40, with higher scores indicating higher perceived stress.

  5. Pregnancy-related anxiety

    Time frame: Measured at baseline and 2, 3, and 4 months after consent.

    Self-reported pregnancy-related anxiety using the PRAQ-R2, which is cored from 0-40, with higher scores indicating higher anxiety.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Hernandez, DO

CONTACT

[email protected]

4149552781

Anna Palatnik, MD

CONTACT

[email protected]

14148056627

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Acronym: MINDBP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 20, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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