N/A
N=120
Monitoring Movement and Health Study
Pregnancy Related · Obesity · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03084302 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants Classified as Having High Sedentary Behavior (by Trajectory) — 45 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Classified as Having High Sedentary Behavior (by Trajectory) |
45 | — |
| PRIMARY Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory) |
29 | — |
| SECONDARY Number of Participants With Excessive Gestational Weight Gain |
49 | — |
| SECONDARY Adverse Pregnancy Outcomes |
19 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03084302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.