Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness training, Garmin Vivoactive 4 watch.
- Who it may be relevant to
- Registry conditions: Preeclampsia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP
Overview
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.
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
Interventions
- 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.
Primary outcome measures
- Feasibility of multisite RCT [Time frame: 3 years]
Secondary outcome measures (5)
- 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.]
- Home blood pressure [Time frame: Daily blood pressure measurements for 6 weeks throughout the study]
- Heart rate variability [Time frame: Up to 34 weeks]
- Perceived stress [Time frame: Measured at baseline and 2, 3, and 4 months after consent.]
- Pregnancy-related anxiety [Time frame: Measured at baseline and 2, 3, and 4 months after consent.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Brown University — Providence
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07218237 · PRO00056473