Recruiting

Observational Study

Sponsor:

Kara Whitaker

Code:

NCT07172880

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 0 - 47

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07172880

Start date

Jul 1, 2023

Status verified date

Sep, 2025

Completion date

Jul 6, 2027

Anticipated

Primary completion date

Jul 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 47

Healthy Volunteers: Accepted

Maternal Inclusion Criteria:

  • 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.

Offspring Exclusion Criteria:

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

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • BMIz [ Time Frame: Through study completion for each participant: birth to 30 months old. ]

Central Contacts and Locations

Central contacts

Kara M Whitaker, PhD, MPH

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

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Kara M Whitaker, PhD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

More Information

Sponsor

Kara Whitaker

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kara Whitaker on 2025-09-22.