Monitoring Movement and Health Study

NCT03084302 | Completed Results

• 1 other identifier: PRO16120430
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Obesity; Hypertension

Keywords

sedentary behavior; physical activity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Number of Participants With Excessive Gestational Weight Gain

  at delivery

• Adverse Pregnancy Outcomes

  during pregnancy

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• weeks pregnant
• years old
• plan to receive prenatal care and deliver with University of Pittsburgh Medical Center providers

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Heart Association: collaborator

Study Sites (1)

Physical Activity and Weight Management Research Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (7)

• 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.

  PMID: 32046663 BACKGROUND

• 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. doi: 10.1123/jpah.2020-0398. Epub 2021 Jan 28.

  PMID: 33508775 RESULT

• 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.

  PMID: 33124060 RESULT

• 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.2021-0097. Print 2021 Aug 1.

  PMID: 34140419 RESULT

• 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 Mar 11.

  PMID: 33715925 RESULT

• Paley JL, Jones MA, Catov JM, Whitaker KM, Kozai AC, Barone Gibbs B. Associations of Physical Activity and Sedentary Behaviors with Depressive Symptoms and Mood Disturbance Throughout Pregnancy. J Womens Health (Larchmt). 2024 Aug;33(8):1128-1138. doi: 10.1089/jwh.2023.0419. Epub 2024 Feb 6.

  PMID: 38324012 DERIVED

• Gibbs BB, Jones MA, Whitaker KM, Ross ST, Davis KK. Measurement of Barriers, Attitudes, and Expectations for Sitting Less in Pregnancy. Am J Health Behav. 2021 Nov 15;45(6):956-970. doi: 10.5993/AJHB.45.6.1.

  PMID: 34969408 DERIVED

MeSH Terms

Conditions

Obesity; Hypertension; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Bethany Barone Gibbs, Associate Professor, University of Pittsburgh
• Organization: University of Pittsburgh

bbarone@pitt.edu

412-383-4002

Study Officials

• Bethany Barone Gibbs, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 20, 2017
• Study Start: March 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 27, 2022
• Results First Posted: September 16, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)