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RecruitingNCT07172880Updated Sep 22, 2025

Pregnancy 24/7 Offspring Study

An observational study in Healthy, sponsored by Kara Whitaker. Recruiting at 3 sites in United States. Open to participants aged 0 Years to 47 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Kara Whitaker · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
0 Years to 47 Years
Sex
All
01

Study 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.

Read the detailed description

Over the past three decades, there has been an alarming increase in the incidence of childhood obesity. Childhood obesity leads to early onset of cardiovascular risk factors, and both obesity and cardiovascular risk factors track into adulthood and contribute to the epidemic of cardiovascular disease (CVD). The Developmental Origins of Health and Disease theory posits that risk for obesity and CVD is, in part, programmed in utero. To prevent this early entrenchment into obesity and CVD, identification of modifiable maternal factors during pregnancy that later impact offspring risk in early childhood is essential. A surprising lack of research investigates the role of prenatal sedentary behavior (SED), moderate-to-vigorous-intensity physical activity (MVPA), and the novel 24-hour behavior paradigm (the composition of SED, physical activity, and sleep) on these adverse offspring outcomes. This is a critical research gap because there is strong physiological rationale that SED, MVPA, and 24-hour behavior in pregnancy could influence offspring health, and these behaviors are modifiable targets for intervention during pregnancy.

This project will address these research gaps with high rigor by leveraging the multi-center cohort study (Pregnancy 24/7, NCT04749849). In Pregnancy 24/7, SED, physical activity, and sleep were prospectively measured using state-of-the-art monitors (activPAL3 micro, Actiwatch Spectrum Plus), along with obesity, gestational weight gain, diet, smoking and adverse pregnancy and birth outcomes across pregnancy. In direct response to the NHLBI's NOT-HL-19-695, the scope of the Pregnancy 24/7 cohort study was expanded by conducting a separate cohort study in the participants' offspring (Pregnancy 24/7 Offspring Study). In the Offspring Study, maternal exposures (already collected in Pregnancy 24/7) will be combined with new, comprehensive assessments of the child's postnatal exposures and outcomes through 24 months. This approach will allow the investigative team to isolate the effects of pregnancy SED, MVPA, and 24-hr behavior on offspring growth and CVD risk measures in early childhood. Growth mixture modeling and state-of-the-art compositional data analyses will be used to address the following aims:

AIM 1: Examine associations of SED in pregnancy with offspring growth and CVD risk measures H1: Offspring of women with higher SED across pregnancy will have more rapid increases in BMIz (primary) and higher adiposity, blood pressure, and pulse wave velocity (secondary) through 24 months.

AIM 2: Examine associations of MVPA in pregnancy with offspring growth and CVD risk measures H2: Offspring of women with lower MVPA across pregnancy will have more rapid increases in BMIz (primary) and higher adiposity, blood pressure, and pulse wave velocity (secondary) through 24 months.

AIM 3: Determine optimal 24-hr behavior compositions in pregnancy to reduce the risk of adverse growth and CVD risk measures in the offspring H3: Statistically reallocating time in SED for LPA or MVPA, but not sleep (in adequate duration sleepers) across pregnancy will be associated with less rapid increases in BMIz (primary), and lower adiposity, blood pressure, and pulse wave velocity (secondary) in the offspring through 24 months.

By combining prenatal and postnatal exposure data, this approach uniquely allows the investigative team to isolate the effects of pregnancy SED, MVPA, and 24-hr behavior on offspring obesity and CVD risk measures in early childhood. This project will inform critically needed primordial prevention interventions to decrease the risk of obesity and CVD.

02

Conditions studied

  • Healthy

Keywords

  • Physical Activity
  • Sleep
  • Sedentary Behavior
  • Cardiovascular Disease Risk
  • Obesity Risk
  • Growth and Development
  • 24- Hour Movement Behaviors
  • Children
  • Pregnancy
03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's planned enrollment of 800 is above the median of 100 across 292 observational studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Kara Whitaker is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 47 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Waist Circumference

    Waist circumference will be measured at the 24- month study visit using a anthropometric tape to the nearest 1 mm.

    Time frame: 23-25 months old.

  2. Tricep and Subscapular Skinfolds

    Subscapular and triceps skinfolds will be assessed at the 24- month visit in mm using a standard skinfold caliper on the right side of the body, with the mean value used. The sum of the mean values will be analyzed, along with WHO age- standardized z-scores for tricep and subscapular skinfolds.

    Time frame: 23-25 months old.

  3. Blood Pressure

    Blood pressure will be assessed at the 24-month visit using a non-mercury aneroid sphygmomanometer following a 5-minute rest, with three readings taken at 1-minute rest intervals. The average of the second and third readings will be used.

    Time frame: 23-25 months old.

  4. Pulse Wave Velocity

    Pulse wave velocity will be measured at the 24- month visit using the Vicorder® System, with cuffs placed on the upper arm and thigh inflated to 55 mmHg for 3-5 heart cycles. After a 5 minute rest, triplicate measurements will be completed in \<5 minutes.

    Time frame: 23-25 months old.

07

Study locations

2 of 3 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: Yes — Individual deidentified data that are relevant to the primary aims of the study will be made available along with a relevant data dictionary.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07172880
Lead sponsor
Kara Whitaker
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, West Virginia University
Responsible party
Kara Whitaker (Associate Professor, University of Iowa) — Sponsor-investigator
First posted
Sep 15, 2025
Start date
Jul 1, 2023
Primary completion
Jul 6, 2027 (estimated)
Completion
Jul 6, 2027 (estimated)
Last update
Sep 22, 2025

Study contacts

Kara M Whitaker, PhD, MPH
Contact
kara-whitaker@uiowa.edu
319-335-7907
Kara M Whitaker, PhD, MPH
principal investigator · University of Iowa
Bethany Barone Gibbs, PhD
principal investigator · West Virginia University
Sharon Ross, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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