Health TrialsbyHealthPanel

Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

ConditionPreeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Multiple gestation

Chronic (pregestational hypertension)

Inability of unwillingness to provide informed consent

Active suicidality or psychosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness training

    Behavioral

    Mindfulness training with trained instructors

  • Garmin Vivoactive 4 watch

    Behavioral

    Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: MT + BiofeedbackExperimental treatment 2 interventions
Group B: MTExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility of multisite RCT

Assess study feasibility as measured by retention rate

Time frame
3 years

Secondary outcomes

1

Acceptability of MINDBP 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.

Time frame
Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training intervention.
2

Home blood pressure

Average systolic and diastolic blood pressure measured using home blood pressure monitoring

Time frame
Daily blood pressure measurements for 6 weeks throughout the study
3

Heart rate variability

Average daily stress score based on heart rate variability from biosensor watch

Time frame
Up to 34 weeks
4

Perceived stress

Self-reported perceived stress using the Perceived Stress Scale, which is scored from 0-40, with higher scores indicating higher perceived stress.

Time frame
Measured at baseline and 2, 3, and 4 months after consent.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov
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