Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy

Официальное название

Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP

Обзор

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.

Подробное описание

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

Вмешательства

• Поведенческое Mindfulness training
  Mindfulness training with trained instructors
• Поведенческое Garmin Vivoactive 4 watch
  Biofeedback with a wearable biosensor that continuously monitors heart rate variability and generates stress scores.

Первичные конечные точки

• Feasibility of multisite RCT [Срок оценки: 3 years]

Вторичные конечные точки (5)

• Acceptability of MINDBP intervention [Срок оценки: Collected at the 3 study visits: 1 week, 1 month, and 2 months after completion of 8-week mindfulness training intervention.]
• Home blood pressure [Срок оценки: Daily blood pressure measurements for 6 weeks throughout the study]
• Heart rate variability [Срок оценки: Up to 34 weeks]
• Perceived stress [Срок оценки: Measured at baseline and 2, 3, and 4 months after consent.]
• Pregnancy-related anxiety [Срок оценки: Measured at baseline and 2, 3, and 4 months after consent.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Brown University — Providence
• Medical College of Wisconsin — Milwaukee

Идентификаторы

NCT: NCT07218237 · PRO00056473

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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