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Monitoring Movement and Health Study (MoM Health)

2022年10月25日 更新者:Bethany Barone Gibbs、University of Pittsburgh

Sedentary Behavior in Pregnancy and Cardiovascular Health: the Monitoring Movement and Health (MoM Health) Study

The investigators will study sedentary behavior (SED) across pregnancy in young women. We hypothesize that SED will increase across pregnancy and that higher SED will be related to worse cardiovascular health, specifically elevated blood pressure (BP) and excessive gestational weight gain (GWG). Pregnancy is a biologically relevant period during which CVD risk factors may develop or worsen, contributing to future CVD. Pregnant women also spend most of their day sedentary, which is defined as too much sitting as distinct from too little exercise. SED has emerged as a risk factor, independent from moderate-to-vigorous physical activity (e.g., exercise), for elevated BP, obesity, diabetes, CVD, and mortality in general populations, but there are no recommendations for SED during pregnancy and few studies evaluate SED across pregnancy. These few studies are limited by small sample size, lack of repeated measures across trimesters, suboptimal SED assessment methodology, and a failure to link with clinical outcomes (e.g., BP, GWG). The investigators will address these gaps in a prospective study that will measure SED in 130 pregnant women across three trimesters using state-of-the-art objective activity monitors capable of measuring min-by-min activity by both intensity and posture. We will also measure BP and GWG during each trimester and, further, will link to and abstract all prenatal clinic weights and BPs, glucose screening results, gestational diabetes, preeclampsia, and adverse birth outcomes. Lastly, with the long-term goal of identifying women at high risk of SED during pregnancy and designing effective interventions, the investigators will efficiently evaluate correlates and determinants of SED which have never been studied during pregnancy.

研究概览

地位

完全的

详细说明

Objective: The investigators aim to conduct a prospective cohort study using state-of-the-art, noninvasive measurement of sedentary behavior in n=130 pregnant women during each trimester of their first pregnancy. We will link sedentary behavior to gestational weight gain, blood pressure, and potential determinants such as demographics, health conditions and behaviors, psychosocial factors, perceptions/beliefs, and the environment.

Specific Aims:

Aim 1: Objectively measure sedentary behavior across pregnancy trimesters Aim 2: Relate objectively-measured sedentary behavior to blood pressure and gestational weight gain across pregnancy Aim 3: Characterize correlates and determinants of sedentary behavior during pregnancy

1.3 Background: Cardiovacular disease (CVD) remains the leading cause of death in women with minimal declines over the past 30 years among women <55 years old. Stagnant rates of CVD mortality in younger women have occurred alongside notable declines in men and older adults and are thought to be due, in part, to high rates of obesity and elevated blood pressure (BP). Related to this, the American Heart Association (AHA) recently identified primordial prevention, a population-level approach that targets preventing rather than treating CVD risk factors, as a necessary strategy to reduce the CVD burden. To achieve primordial prevention, the target must be populations at risk for developing CVD risk factors (vs. those with existing risk factors), such as younger women.

Pregnancy is a biologically unique period for young women during which CVD risk factors such as obesity and high blood pressure (BP) can develop or worsen, contributing to future CVD. Pregnant women also spend most of their time in sedentary behavior (SED). SED is any behavior that occurs in a seated/reclining position with low energy expenditure and is now recognized as a behavior that is distinct from inactivity, or a lack of moderate-vigorous physical activity (MVPA). Though MVPA has known benefits, SED is an emerging, independent risk factor for obesity, CVD, and mortality. Importantly, prolonged bouts of SED (accumulated in bouts lasting 30 min or more) in non-pregnant persons are more strongly related to obesity and induce unfavorable hemodynamic responses, such as increased BP. We hypothesize that too much SED across pregnancy is an important contributor to excess gestational weight gain (GWG) and elevated BP, two important CVD risk factors in young women.

Remarkably, a dearth of studies evaluates SED across pregnancy. In cross-sectional studies, pregnant women spend 50-60% of their day in SED and SED is highest in the 3rd trimester. Yet, no study has evaluated if SED increases across pregnancy (repeated measurements) using best practice SED assessment methodology (objective device capable of capturing posture and intensity). Moreover, no study has evaluated whether greater SED is associated with increased GWG and BP in pregnant women, which in turn are known to impact pregnancy health and later maternal CVD risk. Current guidelines only advise MVPA for pregnant women with no recommendations about SED, highlighting the research gaps about SED and its consequences during pregnancy. Moreover, clarifying the role of SED in pregnancy is important because lowering SED might be a feasible strategy for pregnant women, who have low participation in9 and unique barriers to MVPA. Lastly, little is known about correlates and determinants of SED in pregnancy. Such data are critical for identifying women at risk for high SED during pregnancy and for developing effective interventions.

1.4 Significance: Sedentary behavior is a novel risk factor for weight gain, high BP, and CVD, yet patterns, correlates, determinants and consequences of sedentary behavior are poorly understood in pregnant women. Sedentary behavior is the most common behavior in pregnant women, but the dearth of research studies applying state-of-the-art sedentary behavior assessment methods and with repeated measures across pregnancy is a major research gap that we intend to address with this proposal. To the investigators' knowledge, no studies with optimal sedentary behavior measurement, assessing both posture and intensity while awake (i.e., activPAL), have been conducted in pregnant women. Beyond this, few studies have evaluated temporal trends in sedentary time across gestation. There is no research examining bouts of extended, uninterrupted sedentary time which have particularly deleterious effects on BP and are more strongly related to high BMI. Lastly, correlates and determinants of sedentary behavior are poorly understood overall and, in particular, among pregnant women. Before effective interventions can be designed to reduce sedentary behavior in pregnancy, nonmodifiable and modifiable factors associated with sedentary behavior must be better understood. Thus, the objective, longitudinal measurement of sedentary behavior in pregnancy proposed in this application will determine patterns, correlates, determinants, and consequences of sedentary behavior in pregnancy to move toward future goals of 1) clarifying risks and whether sedentary behavior recommendations are appropriate for pregnant women, 2) identifying groups at risk for high sedentary behavior, and 3) informing intervention targets. Further, this research addresses the AHA's mission to reduce the burden of CVD by investigating a novel strategy for primordial prevention of cardiovascular disease in young women.

研究类型

观察性的

注册 (实际的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15261
        • Physical Activity and Weight Management Research Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

不适用

有资格学习的性别

女性

取样方法

非概率样本

研究人群

We will recruit 120 women in their first trimester of pregnancy. Women must be 18-45 and must be seeing a UPMC provider for their prenatal care and delivery.

描述

Inclusion Criteria:

  • 8-12 weeks pregnant
  • 18-45 years old
  • plan to receive prenatal care and deliver with University of Pittsburgh Medical Center providers

Exclusion Criteria:

  • use of medication to treat diabetes or hypertension
  • medical condition that severely limits physical activity (e.g., cannot walk 2 blocks)
  • other serious medical condition that could affect outcomes (such as systemic lupus, chronic renal disease, or hepatitis)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Pregnant women
Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Participants Classified as Having High Sedentary Behavior (by Trajectory)
大体时间:1st, 2nd, and 3rd trimester of pregnancy
Trajectories identified from objective data across trimesters. High sedentary behavior was defined as the highest group (~10.9 hr/day) based on growth mixture models from the objective data.
1st, 2nd, and 3rd trimester of pregnancy
Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory)
大体时间:1st, 2nd, and 3rd trimester of pregnancy
Low levels of physical activity across trimesters, identified by growth mixture modelling. The low trajectory corresponded to about 114 minutes per week or about 16 minutes per day.
1st, 2nd, and 3rd trimester of pregnancy

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Excessive Gestational Weight Gain
大体时间:at delivery
from study visits and medical records excessive gestational weight gain was defined using 2009 Institute of Medicine Guidelines (reference: Institute of Medicine and National Research Council. Weight gain during pregnancy: reexamining the guidelines. Washington, DC: The National Academies Press; 2009)
at delivery
Adverse Pregnancy Outcomes
大体时间:during pregnancy
from study visits and medical records includes hypertensive disorders of pregnancy, preterm birth, intrauterine growth restrictions, gestational diabetes
during pregnancy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年3月1日

初级完成 (实际的)

2020年6月30日

研究完成 (实际的)

2020年6月30日

研究注册日期

首次提交

2017年3月7日

首先提交符合 QC 标准的

2017年3月13日

首次发布 (实际的)

2017年3月20日

研究记录更新

最后更新发布 (实际的)

2022年10月27日

上次提交的符合 QC 标准的更新

2022年10月25日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PRO16120430

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Individual participant data will be shared with secondary investigators after the following process. 1) Secondary investigators will submit a proposal to the principal investigator that will be reviewed by all Coinvestigators. 2) If all investigators approve, the secondary investigator will obtain institutional review board approval to conduct the proposed analyses, and 3) a deidentified dataset including only requested variables will be provided to the secondary researcher.

IPD 共享时间框架

Data requests will be accepted 6 months after the study funding expired (September 2020).

IPD 共享访问标准

Outside investigators wishing to gain access to MoM Health data will be required to submit a document outlining the rationale and hypotheses to be tested, specific data requested, and analytic plan. This will be reviewed by MoM Health Study investigators for rigor and overlap of existing analyses. All reasonable requests will be honored.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

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