Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Feasibility of multisite RCT
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
MT
Mindfulness training (no access to wearable biosensor data)
干预措施: Mindfulness training (Behavioral)
Control
Routine prenatal care alone
MT + Biofeedback
Mindfulness training plus self-monitoring with access to data from wearable biosensor
干预措施: Mindfulness training (Behavioral)
MT + Biofeedback
Mindfulness training plus self-monitoring with access to data from wearable biosensor
干预措施: Garmin Vivoactive 4 watch (Behavioral)
结局指标
主要结局
Feasibility of multisite RCT
时间窗: 3 years
Assess study feasibility as measured by retention rate
次要结局
- 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.)
- Pregnancy-related anxiety(Measured at baseline and 2, 3, and 4 months after consent.)
- Home blood pressure(Daily blood pressure measurements for 6 weeks throughout the study)
- Heart rate variability(Up to 34 weeks)
- Perceived stress(Measured at baseline and 2, 3, and 4 months after consent.)
研究者
Anna Palatnik, MD
Associate Professor
Medical College of Wisconsin