The Pregnancy 24/7 Cohort Study

NCT04749849 | Completed DMC

• 2 other identifiers: 202002630R01HL153095
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

Moderate to vigorous intensity physical activity is known to reduce the risk of hypertensive disorders of pregnancy and other adverse pregnancy outcomes that increase future maternal cardiovascular disease risk (2018 Physical Activity Guidelines Advisory Committee, 2018; Davenport et al., 2018), yet less than 25% of pregnant women meet public health physical activity guidelines (Hesketh \& Evenson, 2016). More than 95% of the 24-hour day is spent in sedentary behavior, sleep, or light-intensity activity; however, the impacts of these lower intensity activities on adverse pregnancy outcomes are unknown. This multi-site observational cohort study (N=500) will leverage state-of-the-art, 24-hour behavior assessment in each trimester of pregnancy and examine associations with adverse pregnancy outcomes to inform guidelines and future interventions designed to improve women's pregnancy and long-term cardiovascular health.

Conditions

Healthy

Keywords

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Sedentary Behavior; Physical Activity; Sleep

Outcome Measures

Primary Outcomes (1)

• Hypertensive disorders of pregnancy

  Gestational hypertension and preeclampsia, assessed through medical chart review

  Through study completion for each participant, an average of 7.5 months after enrollment

Secondary Outcomes (6)

• Gestational diabetes

  Through study completion for each participant, an average of 7.5 months after enrollment

• Preterm delivery

  At study completion for each participant (delivery), an average of 7.5 months after enrollment

• Low birth weight

  At study completion for each participant (delivery), an average of 7.5 months after enrollment

• All adverse pregnancy outcomes (composite)

  Through study completion for each participant, an average of 7.5 months after enrollment

• Blood pressure

  Through study completion for each participant, an average of 7.5 months after enrollment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women in their first trimester of pregnancy (10 weeks 0 days - 12 weeks 6 days gestation) who complete eligibility screening: 250 from the Iowa site, 125 from the Pittsburgh site, and 125 from the West Virginia site

You may qualify if:

• Pregnant, \<13 weeks gestation
• years of age

You may not qualify if:

• Taking medications for hypertension or diabetes
• Medical condition that severely limits physical activity (cannot walk ½ mile or climb 2 flights of stairs)
• Undergoing treatment for sleep disorders (medication, behavioral treatment, or mechanical therapies)
• Other serious medical condition (such as systemic lupus, chronic renal disease, hepatitis)
• Mother took part in the Pregnancy 24/7 Study and consented to medical chart abstraction of child

Sponsors & Collaborators

• Kara Whitaker: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Pittsburgh: collaborator
• West Virginia University: collaborator

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52240, United States

Location

University of Pittsburg

Pittsburgh, Pennsylvania, 15261, United States

Location

Bethany Barone Gibbs

Morgantown, West Virginia, 26506, United States

Location

Related Publications (11)

• Nuckols VR, Davis KG, Pierce GL, Gibbs BB, Whitaker KM. Associations of physical activity and sedentary time with aortic stiffness and autonomic function in early pregnancy. J Appl Physiol (1985). 2025 Mar 1;138(3):774-782. doi: 10.1152/japplphysiol.00889.2024. Epub 2025 Feb 14.

  PMID: 39951544 BACKGROUND

• Kozai AC, Jones MA, Borrowman JD, Hauspurg A, Catov JM, Kline CE, Whitaker KM, Gibbs BB. Patterns of physical activity, sedentary behavior, and sleep across pregnancy before and during two COVID pandemic years. Midwifery. 2025 Feb;141:104268. doi: 10.1016/j.midw.2024.104268. Epub 2024 Dec 18.

  PMID: 39721225 BACKGROUND

• Gallagher JB, Boonstra DE, Borrowman JD, Unke M, Jones MA, Kline CE, Barone Gibbs B, Whitaker KM. Comparing Multiple Approaches to Estimate Physical Activity, Sedentary Behavior, and Sleep in Pregnancy. J Meas Phys Behav. 2024 Jan;7(1):jmpb.2024-0007. doi: 10.1123/jmpb.2024-0007. Epub 2024 Nov 19.

  PMID: 39949639 BACKGROUND

• 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 BACKGROUND

• Whitaker KM, Jones MA, Wallace MK, Catov J, Barone Gibbs B. Associations of objectively measured physical activity and sedentary time with pregnancy-specific health-related quality of life. Midwifery. 2022 Jan;104:103202. doi: 10.1016/j.midw.2021.103202. Epub 2021 Nov 11.

  PMID: 34801955 BACKGROUND

• 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 BACKGROUND

• Jones MA, Whitaker KM, Paley JL, Thrower A, Stoner L, Barone Gibbs B. Brachial-femoral pulse wave velocity in 2-4-year-old children: a feasibility study. Blood Press Monit. 2023 Feb 1;28(1):11-16. doi: 10.1097/MBP.0000000000000622. Epub 2022 Nov 1.

  PMID: 36606476 BACKGROUND

• Jones MA, Whitaker KM, Taverno Ross SE, Davis K, Libertus K, Barone Gibbs B. Maternal Sedentary Behavior and Physical Activity across Pregnancy and Early Childhood Motor Development. Children (Basel). 2021 Jun 25;8(7):549. doi: 10.3390/children8070549.

  PMID: 34201936 BACKGROUND

• Jones MA, Whitaker K, Taverno Ross SE, Davis K, Libertus K, Gibbs BB. Maternal Sedentary Behavior and Physical Activity across Pregnancy and Early Childhood Growth. Child Obes. 2022 Sep;18(6):399-408. doi: 10.1089/chi.2021.0202. Epub 2022 Feb 2.

  PMID: 35108109 BACKGROUND

• Jones MA, Diesel SJ, Gibbs BB, Whitaker KM. Concurrent Agreement Between ActiGraph and activPAL for Measuring Physical Activity in Pregnant Women and Office Workers. J Meas Phys Behav. 2022 Jun;5(2):69-75. doi: 10.1123/jmpb.2021-0050. Epub 2022 Apr 23.

  PMID: 36340243 BACKGROUND

• Whitaker KM, Jones MA, Smith K, Catov J, Feghali M, Kline CE, Santillan M, Santillan D, Zimmerman B, Gibbs BB. Study Design and Protocol of the Multisite Pregnancy 24/7 Cohort Study. Am J Epidemiol. 2024 Feb 5;193(3):415-425. doi: 10.1093/aje/kwad208.

  PMID: 37939072 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Kara Whitaker, PhD, MPH

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Bethany Barone Gibbs, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Christopher Kline, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 11, 2021
• Study Start: February 1, 2021
• Primary Completion: February 18, 2025
• Study Completion: April 11, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available as soon as possible, no later than the time of an associated publication, or the end of the award period, whichever comes first.
• Access Criteria: Data access will be provided to external researchers who provide a methodologically sound proposal for secondary data analysis that is approved by the investigators of the study. Proposals should be directed to the study PI.

Locations

US (3)