Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy
NCT07218237 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2025-10-17
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.
Conditions
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.
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Anna Palatnik, MD · Medical College of Wisconsin
-
Margaret Bublitz, PhD · Brown University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2028-03-31
- Completion
- 2028-10-31
Countries
- United States
Study Locations
More Related Trials
-
Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring
NCT02872896 ·Status: COMPLETED ·Phase: NA
-
Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device
NCT04379986 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
NCT03257189 ·Status: COMPLETED ·Phase: NA
-
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
NCT03504189 ·Status: COMPLETED ·Phase: NA
-
Wireless Disposable SpO2 Sensor Hypoxia Testing
NCT06211530 ·Status: COMPLETED ·Phase: NA
-
Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings
NCT04233827 ·Status: COMPLETED
-
Non-Invasive Blood Pressure Monitoring in ICU Patients Using the DARE Device
NCT07052123 ·Status: RECRUITING ·Phase: NA
-
Vital Signs Patch Early Feasibility and Usability Study
NCT02521922 ·Status: COMPLETED ·Phase: NA
-
A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data
NCT05498298 ·Status: COMPLETED ·Phase: NA
-
Breathing Device for Orthostatic Hypotension (OH)
NCT00962884 ·Status: WITHDRAWN ·Phase: NA
-
Hypertension Management Using Remote Patient Monitoring: Study 2
NCT04764318 ·Status: COMPLETED
-
Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations
NCT06935513 ·Status: RECRUITING ·Phase: NA
-
Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
NCT05730465 ·Status: RECRUITING ·Phase: NA
-
Sleep Health in Pregnant Women in ENRICH
NCT07216287 ·Status: ENROLLING_BY_INVITATION
-
Performance Assessment of a Remote Patient Monitoring Device
NCT02570906 ·Status: COMPLETED
-
Data Collection of Heart Rate and Blood Pressure
NCT05095753 ·Status: UNKNOWN
-
OBPM_HARMONY: Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor
NCT07099716 ·Status: NOT_YET_RECRUITING
-
The Prevention of Failure to Rescue Using Early Warning Scoring
NCT01197326 ·Status: COMPLETED
-
Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization
NCT05378139 ·Status: RECRUITING
-
Device for Monitoring Pain During Intraoperative, Pre/Post Surgical Periods: Comparison With Standard of Care Monitoring
NCT02630134 ·Status: TERMINATED ·Phase: NA
-
Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sensor
NCT03982654 ·Status: COMPLETED ·Phase: NA
-
CNAP™ Monitor Study
NCT01356082 ·Status: COMPLETED
-
Vital Signs Patch: Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
NCT02518100 ·Status: COMPLETED ·Phase: NA
-
Maternal Non-Stress Testing
NCT04343482 ·Status: COMPLETED
-
PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
NCT04031430 ·Status: COMPLETED ·Phase: NA