HealthyNCT07172880
Pregnancy 24/7 Offspring Study
An observational study of Healthy, run by Kara Whitaker at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 47 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 800 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2023to 6 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 47 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Kara M Whitaker, PhD, 319-335-7907, kara-whitaker@uiowa.edu
Brooke Anthos, BS, 319-335-7315, hhp-preg247@uiowa.edu
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Bethany Barone Gibbs, PhD, 412-310-5988, bethany.gibbs@hsc.wvu.edu
- Active, not recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Sedentary Behavior, Physical Activity, and 24-hour Behavior in Pregnancy and Offspring Health: the Pregnancy 24/7 Offspring Study
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.
- Conditions
- Healthy
- Keywords
- Physical Activity, Sleep, Sedentary Behavior, Cardiovascular Disease Risk, Obesity Risk, Growth and Development, 24- Hour Movement Behaviors, Children, Pregnancy
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion for each participant: birth to 30 months old.
Secondary outcomes (4)
Waist Circumference
Waist circumference will be measured at the 24- month study visit using a anthropometric tape to the nearest 1 mm.
Measured: 23-25 months old.
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.
Measured: 23-25 months old.
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.
Measured: 23-25 months old.
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.
Measured: 23-25 months old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jul 2023
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kara Whitaker
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, West Virginia University
- Responsible party
- Sponsor-investigator, Kara Whitaker, University of Iowa
- Investigators
- Kara M Whitaker, PhD, MPH, Principal investigator, University of IowaBethany Barone Gibbs, PhD, Principal investigator, West Virginia UniversitySharon Ross, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172880
- Sponsor's protocol ID
- 202211227
- Other IDs
- R01HL164662
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified data that are relevant to the primary aims of the study will be made available along with a relevant data dictionary.
Publications
Whitaker KM, Jones MA, Crisp AH, Kim J, Taverno Ross SE, Anthos BN, Marske T, Rahman S, Marrero-Rivera JP, Thrower A, Feghali M, Haggerty T, Mozena E, Roghair R, Zimmerman B, Gibbs BB. Sedentary Behavior, Physical Activity, and Sleep During Pregnancy and Offspring Health: Protocol for the Pregnancy 24/7 Offspring Multi-Site Cohort Study. J Am Heart Assoc. 2026 Oct 10:e050797. doi: 10.1161/JAHA.126.050797. Online ahead of print.
PubMed 42857985
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Behavior, Physical Activity, and 24-hour Behavior in Pregnancy and Offspring Health: the Pregnancy 24/7 Offspring Study
- ClinicalTrials.gov ID
- NCT07172880
- Acronym / sponsor ID
- 202211227
- Conditions
- Healthy
- Keywords
- Physical Activity, Sleep, Sedentary Behavior, Cardiovascular Disease Risk, Obesity Risk, Growth and Development, 24- Hour Movement Behaviors, Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Kara WhitakerUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, West Virginia University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 47 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BMIz
Time frame: Through study completion for each participant: birth to 30 months old.
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.
4 secondary outcomes
Waist Circumference
Time frame: 23-25 months old.
Tricep and Subscapular Skinfolds
Time frame: 23-25 months old.
Blood Pressure
Time frame: 23-25 months old.
Pulse Wave Velocity
Time frame: 23-25 months old.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 42857985Whitaker KM, Jones MA, Crisp AH, Kim J, Taverno Ross SE, Anthos BN, Marske T, Rahman S, Marrero-Rivera JP, Thrower A, Feghali M, Haggerty T, Mozena E, Roghair R, Zimmerman B, Gibbs BB. Sedentary Behavior, Physical Activity, and Sleep During Pregnancy and Offspring Health: Protocol for the Pregnancy 24/7 Offspring Multi-Site Cohort Study. J Am Heart Assoc. 2026 Oct 10:e050797. doi: 10.1161/JAHA.126.050797. Online ahead of print.
- Individual participant dataSharing planned: Yes. Individual deidentified data that are relevant to the primary aims of the study will be made available along with a relevant data dictionary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Kara Whitaker at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara M Whitaker, PhD, MPH (319-335-7907, kara-whitaker@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMIz (time frame: Through study completion for each participant: birth to 30 months old.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07172880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.