- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03765684
Factors Affecting Newborn Body Composition and Later Health in Helsinki Birth Cohort 2018-2022 (HeBiCo)
Effects of Various Parental and Gestational Factors on Offspring Body Composition and Health in Later Life in Helsinki Birth Cohort 2018-2022
Study Overview
Status
Detailed Description
Helsinki Birth Cohort 2018-2022 (HeBiCo) study is designed to find evidence between various intrauterine exposures and offspring adiposity and later health. It will be examined how different maternal (e.g. chronic diseases, ethnicity, BMI), and obstetric factors (e.g. gestational weight gain, diagnoses during pregnancy) as well as parental lifestyle and psychological aspects (e.g. diet quality, physical activity, depression and anxiety) are associated with newborn body composition and later health (e.g. obesity and neurocognitive health).
In the first phase of the study the participants are recruited on postnatal ward after delivery. The umbilical cord blood sample will be collected of all the neonates. After a consent the participants fill in the digital background, food frequency, depression and physical activity questionnaires. If the parents do not give their consent, the umbilical cord blood sample will be destroyed. Body composition of offspring will be assessed within 72 hours after birth. Registry data will be collected.
The second phase of the HeBiCo study is based on the HUS WomensHub treatment path and/or Apotti platform. The second phase of the HeBiCo constitutes of the mother-child pairs (and fathers/spouses) whose pregnancy can be followed from the early pregnancy to the end of the pregnancy through treatment path. Body composition of offspring born in Helsinki Women's Hospital will be assessed within 72 hours after birth.
The future studies will include 1) the intervention studies with digital service concept through WomensHub platform, and 2) the follow-up studies of offspring and parents in later life (to establish e.g. growth trajectories and later metabolic health of offspring).
The first phase of the HeBiCo study was registered 3/2018.
The second phase will be registered now.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Helsinki, Finland, 00029
- HUS Women's hospital, Helsinki Unversity Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The first phase of the Helsinki Birth Cohort (HeBiCo) will be constituted of all the neonates whose body composition at birth can be obtained at Helsinki Women's Hospital, and whose mothers and fathers/spouses fill out the questionnaires after delivery (background, food frequency (FFQ), and depression questionnaires (EPDS, CES-D)).
In the second phase of HeBiCo, participants will be recruited any time during pregnancy and also at postnatal ward after delivery.
Description
Inclusion Criteria:
Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District.
Exclusion Criteria:
Inability to communicate in Finnish language
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neonatal body fat %
Time Frame: Within 72 hours of birth
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Measured with PEA POD Cosmed® Infant Body Composition Assessment system
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Within 72 hours of birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Newborn weight
Time Frame: Within 2 hours of birth
|
Birth weight in kilograms
|
Within 2 hours of birth
|
|
Newborn height
Time Frame: Within 2 hours of birth
|
Birth height in meters
|
Within 2 hours of birth
|
|
ASQ-3
Time Frame: 3 months, 1 year and 2 years of age
|
Ages and Stages Questionnaire-3
|
3 months, 1 year and 2 years of age
|
|
ITSEA
Time Frame: 3 months, 1 year and 2 years of age
|
Infant Toddler Social Emotional Assessment
|
3 months, 1 year and 2 years of age
|
Collaborators and Investigators
Investigators
- Principal Investigator: Saila SB Koivusalo, Helsinki University Hospital, Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS/180/2018, HUS/512/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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