Obesity Clinical Trial
— MoM HealthOfficial title:
Sedentary Behavior in Pregnancy and Cardiovascular Health: the Monitoring Movement and Health (MoM Health) Study
NCT number | NCT03084302 |
Other study ID # | PRO16120430 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | June 30, 2020 |
Verified date | October 2022 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Physical Activity and Weight Management Research Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | American Heart Association |
United States,
Barone Gibbs B, Jones MA, Jakicic JM, Jeyabalan A, Whitaker KM, Catov JM. Objectively Measured Sedentary Behavior and Physical Activity Across 3 Trimesters of Pregnancy: The Monitoring Movement and Health Study. J Phys Act Health. 2021 Mar 1;18(3):254-261 — View Citation
Barone Gibbs B, Paley JL, Jones MA, Whitaker KM, Connolly CP, Catov JM. Validity of self-reported and objectively measured sedentary behavior in pregnancy. BMC Pregnancy Childbirth. 2020 Feb 11;20(1):99. doi: 10.1186/s12884-020-2771-z. — View Citation
Jones MA, Catov JM, Jeyabalan A, Whitaker KM, Barone Gibbs B. Sedentary behaviour and physical activity across pregnancy and birth outcomes. Paediatr Perinat Epidemiol. 2021 May;35(3):341-349. doi: 10.1111/ppe.12731. Epub 2020 Oct 30. — View Citation
Jones MA, Whitaker K, Wallace M, Barone Gibbs B. Demographic, Socioeconomic, and Health-Related Predictors of Objectively Measured Sedentary Time and Physical Activity During Pregnancy. J Phys Act Health. 2021 Jun 17;18(8):957-964. doi: 10.1123/jpah.2021- — View Citation
Whitaker KM, Zhang D, Kline CE, Catov J, Barone Gibbs B. Associations of Sleep With Sedentary Behavior and Physical Activity Patterns Across Pregnancy Trimesters. Womens Health Issues. 2021 Jul-Aug;31(4):366-375. doi: 10.1016/j.whi.2021.02.003. Epub 2021 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Classified as Having High Sedentary Behavior (by Trajectory) | 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 | |
Primary | Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory) | 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 | |
Secondary | Number of Participants With Excessive Gestational Weight Gain | 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 | |
Secondary | Adverse Pregnancy Outcomes | from study visits and medical records includes hypertensive disorders of pregnancy, preterm birth, intrauterine growth restrictions, gestational diabetes | during pregnancy |
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