Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy
Recruiting · NCT07218237 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical College of Wisconsin
View the official record on ClinicalTrials.gov →Interventions studied
Garmin Vivoactive 4 watchMindfulness training
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 2 US states.
- Brown University - Providence, Rhode Island, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States