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Clinical Trials/NCT03084302
NCT03084302CompletedNot Applicable

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

University of Pittsburgh1 site in 1 country120 target enrollmentStarted: March 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory)

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory)

Time Frame: 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.

Number of Participants Classified as Having High Sedentary Behavior (by Trajectory)

Time Frame: 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.

Secondary Outcomes

  • Number of Participants With Excessive Gestational Weight Gain(at delivery)
  • Adverse Pregnancy Outcomes(during pregnancy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bethany Barone Gibbs

PhD

University of Pittsburgh

Study Sites (1)

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