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Monitoring Movement and Health Study (MoM Health)

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ClinicalTrials.gov Identifier: NCT03084302
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : September 16, 2021
Last Update Posted : October 27, 2022
American Heart Association
Information provided by (Responsible Party):
Bethany Barone Gibbs, University of Pittsburgh

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.

Condition or disease
Pregnancy Related Obesity Hypertension

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sedentary Behavior in Pregnancy and Cardiovascular Health: the Monitoring Movement and Health (MoM Health) Study
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Number of Participants With Excessive Gestational Weight Gain [ Time Frame: 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)

  2. Adverse Pregnancy Outcomes [ Time Frame: during pregnancy ]
    from study visits and medical records includes hypertensive disorders of pregnancy, preterm birth, intrauterine growth restrictions, gestational diabetes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084302

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United States, Pennsylvania
Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
American Heart Association
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Principal Investigator: Bethany Barone Gibbs, PhD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Bethany Barone Gibbs, University of Pittsburgh:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bethany Barone Gibbs, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03084302    
Other Study ID Numbers: PRO16120430
First Posted: March 20, 2017    Key Record Dates
Results First Posted: September 16, 2021
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Data requests will be accepted 6 months after the study funding expired (September 2020).
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bethany Barone Gibbs, University of Pittsburgh:
sedentary behavior
physical activity
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases