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临床试验/NCT04749849
NCT04749849已完成不适用

Sedentary Behavior, Physical Activity, Sleep, and Cardiovascular Risk in Pregnancy: the Pregnancy 24/7 Cohort Study

Kara Whitaker3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
3
主要终点
Hypertensive disorders of pregnancy

研究概览

简要总结

Moderate to vigorous intensity physical activity is known to reduce the risk of hypertensive disorders of pregnancy and other adverse pregnancy outcomes that increase future maternal cardiovascular disease risk (2018 Physical Activity Guidelines Advisory Committee, 2018; Davenport et al., 2018), yet less than 25% of pregnant women meet public health physical activity guidelines (Hesketh & Evenson, 2016). More than 95% of the 24-hour day is spent in sedentary behavior, sleep, or light-intensity activity; however, the impacts of these lower intensity activities on adverse pregnancy outcomes are unknown. This multi-site observational cohort study (N=500) will leverage state-of-the-art, 24-hour behavior assessment in each trimester of pregnancy and examine associations with adverse pregnancy outcomes to inform guidelines and future interventions designed to improve women's pregnancy and long-term cardiovascular health.

详细描述

The overall goal of this study is to use state-of-the-art monitors to objectively measure the 24-hour behavioral cycle (sedentary behavior, sleep, and physical activity) in each trimester of pregnancy, and to examine associations of these behaviors with hypertensive disorders of pregnancy and other adverse pregnancy outcomes linked with future cardiovascular disease (CVD) risk. For this, 500 women in early pregnancy will be recruited to take part in a multi-site (Universities of Iowa and Pittsburgh) cohort study. Women will wear two state-of-the-art devices for seven days in each trimester of pregnancy to assess sedentary behavior and physical activity (activPAL micro 3) as well as sleep (ActiWatch Spectrum Plus). Hypertensive disorders of pregnancy and other adverse outcomes will be obtained through medical chart abstraction. This project will inform guidelines on optimal 24-hour behavioral patterns in pregnancy, as well as lay the foundation for future studies testing behavioral interventions in pregnancy to achieve optimal outcomes and improve women's long-term cardiovascular health.

Specific Aims:

AIM 1: Examine associations of sedentary behavior patterns with hypertensive disorders of pregnancy. Hypothesis: Women with a consistently high sedentary behavior pattern across trimesters will have higher incidence of gestational hypertension/preeclampsia, after adjustment for MVPA.

AIM 2: Examine associations of sleep patterns with hypertensive disorders of pregnancy. Hypothesis: Women with short sleep duration or poor sleep quality patterns across trimesters will have higher incidence of gestational hypertension/preeclampsia, after adjustment for MVPA.

AIM 3: Determine optimal 24-hour behavioral patterns during pregnancy to reduce the risk of hypertensive disorders of pregnancy. Hypothesis: Statistically reallocating time in sedentary behavior for LPA or MVPA, but not sleep (among adequate duration sleepers), will be associated with lower incidence of gestational hypertension/preeclampsia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hypertensive disorders of pregnancy

时间窗: Through study completion for each participant, an average of 7.5 months after enrollment

Gestational hypertension and preeclampsia, assessed through medical chart review

次要结局

  • Gestational diabetes(Through study completion for each participant, an average of 7.5 months after enrollment)
  • Preterm delivery(At study completion for each participant (delivery), an average of 7.5 months after enrollment)
  • Low birth weight(At study completion for each participant (delivery), an average of 7.5 months after enrollment)
  • All adverse pregnancy outcomes (composite)(Through study completion for each participant, an average of 7.5 months after enrollment)
  • Blood pressure(Through study completion for each participant, an average of 7.5 months after enrollment)
  • Glycemic control(Through study completion for each participant, an average of 7.5 months after enrollment)

研究者

发起方
Kara Whitaker
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kara Whitaker

Associate Professor

University of Iowa

研究点 (3)

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