HeBiCo: Factors Affecting Newborn Body Composition and Later Health in Helsinki Birth Cohort 2018-2022

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03765684
Collaborator
University of Helsinki (Other), Finnish Institute for Health and Welfare (Other), UKK Institute (Other)
1,000
1
49
20.4

Study Details

Study Description

Brief Summary

In Helsinki Birth Cohort 2018-2022 a large, longitudinal and well-phenotyped birth cohort of infants and their parents will be established. Mothers, fathers/spouses and their children in Helsinki and Uusimaa Hospital District are recruited in the study and newborn composition of the children born in Helsinki Women's Hospital will be measured. Data on maternal and paternal diet quality, physical activity and depression during and after pregnancy will be collected and data from the hospital and national registers will be collected. Health of offspring and parents will be followed during their later life.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of Various Parental and Gestational Factors on Offspring Body Composition and Health in Later Life in Helsinki Birth Cohort 2018-2022
    Actual Study Start Date :
    Dec 1, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Neonatal body fat % [Within 72 hours of birth]

      Measured with PEA POD CosmedĀ® Infant Body Composition Assessment system

    Secondary Outcome Measures

    1. Newborn weight [Within 2 hours of birth]

      Birth weight in kilograms

    2. Newborn height [Within 2 hours of birth]

      Birth height in meters

    3. ASQ-3 [3 months, 1 year and 2 years of age]

      Ages and Stages Questionnaire-3

    4. ITSEA [3 months, 1 year and 2 years of age]

      Infant Toddler Social Emotional Assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District.

    Exclusion Criteria:

    Inability to communicate in Finnish language

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HUS Women's hospital, Helsinki Unversity Hospital Helsinki Finland 00029

    Sponsors and Collaborators

    • Helsinki University Central Hospital
    • University of Helsinki
    • Finnish Institute for Health and Welfare
    • UKK Institute

    Investigators

    • Principal Investigator: Saila SB Koivusalo, Helsinki University Hospital, Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saila Koivusalo, Associate Professor, Development Manager, Helsinki University Central Hospital
    ClinicalTrials.gov Identifier:
    NCT03765684
    Other Study ID Numbers:
    • HUS/180/2018, HUS/512/2019
    First Posted:
    Dec 5, 2018
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 7, 2021