Pregnancy 24/7 Offspring Study

NCT07172880 | Recruiting DMC

• 2 other identifiers: 202211227R01HL164662
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 3

Brief Summary

There is growing evidence that maternal health and behaviors in pregnancy, such as pre-pregnancy obesity, excessive gestational weight gain, poor diet, smoking, and adverse pregnancy outcomes, are linked to fetal programming for obesity and cardiovascular disease (CVD) risk in the offspring. Yet, there is a surprising lack of research on the role of prenatal sedentary behavior, physical activity, and sleep (conceptualized together as 24-hour behavior) on offspring obesity risk and CVD risk; this is an unfortunate research gap since there is strong physiological rationale that these behaviors in pregnancy could influence offspring health and are modifiable intervention targets in pregnancy. This multi-site observational cohort study will leverage state-of-the-art, 24-hour behavior assessment in each trimester of pregnancy, collected as part of the Pregnancy 24/7 cohort study and add additional assessments of offspring growth, adiposity, and CVD risk through 24 months to inform future primordial prevention interventions to decrease the risk of offspring obesity and CVD across the lifespan.

Conditions

Healthy

Keywords

Physical Activity; Sleep; Sedentary Behavior; Cardiovascular Disease Risk; Obesity Risk; Growth and Development; 24- Hour Movement Behaviors; Children; Pregnancy

Outcome Measures

Primary Outcomes (1)

• BMIz

  BMI z-scores will be calculated using WHO growth standards from weight and length data abstracted from well-child visits (birth to 30 months; \~10 per child) and direct measurements at the 24-month study visit.

  Through study completion for each participant: birth to 30 months old.

Secondary Outcomes (4)

• Waist Circumference

  23-25 months old.

• Tricep and Subscapular Skinfolds

  23-25 months old.

• Blood Pressure

  23-25 months old.

• Pulse Wave Velocity

  23-25 months old.

Study Arms (2)

Mother

Women who were enrolled in the Pregnancy 24/7 Cohort Study and subsequently delivered a live-born infant.

Child

Children from birth to 30 months of age, born to participants enrolled in the Pregnancy 24/7 Cohort Study.

Eligibility Criteria

• Age: 0 Years - 47 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who participated in the Pregnancy 24/7 Cohort Study and gave birth who complete eligibility screening from three sites Iowa N=225, Pittsburgh N=112, and West Virgina N=113. We anticipate N=360 for 24-month chart abstraction and questionnaires and N=315 for the in-person visit, with approximately equal sex distribution among offspring.

You may qualify if:

• Enrolled in Pregnancy 24/7 Study.
• Completed at least one 24-hr behavior assessment, with valid objective activity monitor data and questionnaires.
• Pregnancy resulted in singleton live birth.

You may not qualify if:

• Child diagnosed with congenital or chromosomal abnormalities that may affect growth or CVD risk.

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, 52242, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

ACTIVE NOT RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kara M Whitaker, PhD, MPH

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Bethany Barone Gibbs, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Sharon Ross, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara M Whitaker, PhD, MPH

CONTACT

319-335-7907; kara-whitaker@uiowa.edu

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: September 8, 2025
• First Posted: September 15, 2025
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

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)