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Clinical Trials/NCT03765684
NCT03765684Active, not recruitingNot Applicable

Effects of Various Parental and Gestational Factors on Offspring Body Composition and Health in Later Life in Helsinki Birth Cohort 2018-2022

Helsinki University Central Hospital1 site in 1 country1,000 target enrollmentStarted: December 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,000
Locations
1
Primary Endpoint
Neonatal body fat %

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
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

Outcomes

Primary Outcomes

Neonatal body fat %

Time Frame: Within 72 hours of birth

Measured with PEA POD Cosmed® Infant Body Composition Assessment system

Secondary Outcomes

  • ASQ-3(3 months, 1 year and 2 years of age)
  • Newborn height(Within 2 hours of birth)
  • Newborn weight(Within 2 hours of birth)
  • ITSEA(3 months, 1 year and 2 years of age)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saila Koivusalo

Associate Professor, Development Manager

Helsinki University Central Hospital

Study Sites (1)

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