What this study is
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.
What's being tested
- Mindfulness training
Intervention · BEHAVIORAL
Mindfulness training with trained instructors
- Garmin Vivoactive 4 watch
Intervention · BEHAVIORAL
Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.
Study details
- Official title
- Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP
- Sponsor
- Medical College of Wisconsin
- Conditions
- Preeclampsia
- Enrolling
- 90 people
- Starts
- 2026-04-01
- Est. completion
- 2028-10-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou 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 can't join 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openBrown University
Providence, Rhode Island, United States
- Margaret Bublitz, PhD · Contact401-793-7884mbublitz@brownhealth.org
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Anna Palatnik, MD · Contact414-805-6627apalatnik@mcw.edu
- Alyssa Hernandez, DO · Contact4149552781alyhernandez@mcw.edu
Recruiting
Study team
Sponsor
Medical College of Wisconsin
Study ID PRO00056473
Principal investigator
Anna Palatnik, MD
Medical College of Wisconsin
Principal investigator
Margaret Bublitz, PhD
Brown University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.