Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

NCT07218237 | Not Yet Recruiting DMC

• 1 other identifier: PRO00056473
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Preeclampsia

Keywords

Hypertensive disorders of pregnancy; Mindfulness; Biofeedback

Outcome Measures

Primary Outcomes (1)

• Feasibility of multisite RCT

  Assess study feasibility as measured by retention rate

  3 years

Secondary Outcomes (5)

• Acceptability of MINDBP intervention

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

• Home blood pressure

  Daily blood pressure measurements for 6 weeks throughout the study

• Heart rate variability

  Up to 34 weeks

• Perceived stress

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

• Pregnancy-related anxiety

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

Study Arms (3)

MT + Biofeedback

EXPERIMENTAL

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

Behavioral: Mindfulness training; Behavioral: Garmin Vivoactive 4 watch

MT

EXPERIMENTAL

Mindfulness training (no access to wearable biosensor data)

Behavioral: Mindfulness training

Control

NO INTERVENTION

Routine prenatal care alone

Interventions

Mindfulness training BEHAVIORAL

Mindfulness training with trained instructors

MT; MT + Biofeedback

Garmin Vivoactive 4 watch BEHAVIORAL

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

MT + Biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (2)

Brown University

Providence, Rhode Island, 02904, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anna Palatnik, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Margaret Bublitz, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Palatnik, MD

CONTACT

14148056627; apalatnik@mcw.edu

Alyssa Hernandez, DO

CONTACT

4149552781; alyhernandez@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 20, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The repository will make the data accessible within 2 years of the last patient's last study visit or at the end of the performance period, or no later than the date of publication, whichever is sooner. Data will be preserved within the repositories for at least three years following the completion of the grant, as required by federal retention guidelines.
• Access Criteria: Data that are necessary for and of sufficient quality to validate and replicate the study findings for the primary aims will be shared. We agree that the data will be deposited and made available as public use data to the research community via BioLINCC, and that these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. We agree that the names and institutions of persons either given or denied access to the data, and the basis for such decisions, will be summarized in the annual progress report. Interested investigators will need to seek approval for data access from the contact PI.

Locations

US (2)