Preeclampsia
Conditions
Keywords
Hypertensive disorders of pregnancy, Mindfulness, Biofeedback
Brief summary
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
BEHAVIORALMindfulness training
Mindfulness training with trained instructors
BEHAVIORALGarmin Vivoactive 4 watch
Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of multisite RCT | 3 years | Assess study feasibility as measured by retention rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of MINDBP intervention | Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training intervention. | Assess intervention acceptability using Theoretical Framework of Acceptability Questionns (TFAQ). The TFAQ include 8 Likert-scale items which are averaged to provide an overall score from 1-5, with 5 indicating higher acceptability. |
| Home blood pressure | Daily blood pressure measurements for 6 weeks throughout the study | Average systolic and diastolic blood pressure measured using home blood pressure monitoring |
| Heart rate variability | Up to 34 weeks | Average daily stress score based on heart rate variability from biosensor watch |
| Perceived stress | Measured at baseline and 2, 3, and 4 months after consent. | Self-reported perceived stress using the Perceived Stress Scale, which is scored from 0-40, with higher scores indicating higher perceived stress. |
| Pregnancy-related anxiety | Measured at baseline and 2, 3, and 4 months after consent. | Self-reported pregnancy-related anxiety using the PRAQ-R2, which is cored from 0-40, with higher scores indicating higher anxiety. |
Countries
United States
Contacts
CONTACTAnna Palatnik, MD
CONTACTAlyssa Hernandez, DO
PRINCIPAL_INVESTIGATORAnna Palatnik, MD
Medical College of Wisconsin
PRINCIPAL_INVESTIGATORMargaret Bublitz, PhD
Brown University
Outcome results
None listed