Mindfulness with wearables to help prevent high blood pressure problems in pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MINDBP study will enroll 90 pregnant individuals at risk for hypertensive disorders of pregnancy and randomize them to three groups: mindfulness training with wearable biosensors, mindfulness training alone, or routine prenatal care. Participants in the mindfulness arms will receive eight weekly phone-based sessions with two booster sessions after the intervention, while all participants wear a Garmin Vivoactive 4. Outcomes include feasibility, fidelity, and acceptability, with physiological and psychological measures (blood pressure, heart rate, heart rate variability, perceived stress, and pregnancy-related anxiety) assessed at baseline (≤16 weeks), after the intervention (~24 weeks), and after each booster (~28 and 32 weeks). The study is conducted at two sites: Brown University and Medical College of Wisconsin, led by MCW with collaboration at Brown.

Why it matters

Who can join: the full rules

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)

Where it's running

• Brown University
  Providence, Rhode Island, United States Recruiting
• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Anna Palatnik, MD — Medical College of Wisconsin
• Study coordinator: Anna Palatnik, MD
• Email: apalatnik@mcw.edu
• Phone: 14148056627

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.