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NCT03084302 · ClinicalTrials.gov registry record
Monitoring Movement and Health Study
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 120
- Enrollment target
NCT03084302: Completed study, sponsored by University of Pittsburgh.
NCT03084302 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03084302 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2020-06-30 |
What the finished NCT03084302 record still lists
NCT03084302 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03084302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03084302 about?
NCT03084302 is a clinical study titled "Monitoring Movement and 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). Pre...
What is the current status of trial NCT03084302?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2017-03-01. Estimated completion is 2020-06-30.
Who is sponsoring clinical trial NCT03084302?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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