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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MT + Biofeedback 		Mindfulness training plus self-monitoring with access to data from wearable biosensor
  • Behavioral: Mindfulness training
    Mindfulness training with trained instructors
  • Behavioral: Garmin Vivoactive 4 watch
    Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.
Experimental
MT 		Mindfulness training (no access to wearable biosensor data)
  • Behavioral: Mindfulness training
    Mindfulness training with trained instructors
  • Behavioral: Garmin Vivoactive 4 watch
    Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.
No Intervention
Control 		Routine prenatal care alone

Recruiting Locations

Brown University
Providence, Rhode Island 02904
Contact:
Margaret Bublitz, PhD
401-793-7884
mbublitz@brownhealth.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Anna Palatnik, MD
14148056627
apalatnik@mcw.edu

More Details

Status
Recruiting
Sponsor
Medical College of Wisconsin

Study Contact

Anna Palatnik, MD
14148056627
apalatnik@mcw.edu

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.