Clinical trial NCT03765684: Factors Affecting Newborn Body Composition and Later Health in Helsinki Birth Cohort 2018-2022
Official title: Effects of Various Parental and Gestational Factors on Offspring Body Composition and Health in Later Life in Helsinki Birth Cohort 2018-2022
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Offspring, Adult
Lifestyle
Obesity, Childhood
Pregnancy Related
Child Development
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Finnish Institute for Health and Welfare
name: UKK Institute
First posted: 2018-12-05
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

The second phase will be registered now.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Inability to communicate in Finnish language

Primary outcomes:
measure: Neonatal body fat %
timeFrame: Within 72 hours of birth
Secondary outcomes:
measure: Newborn weight
timeFrame: Within 2 hours of birth
measure: Newborn height
timeFrame: Within 2 hours of birth
measure: ASQ-3
timeFrame: 3 months, 1 year and 2 years of age
measure: ITSEA
timeFrame: 3 months, 1 year and 2 years of age
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS Women's hospital, Helsinki Unversity Hospital
Study officials:
affiliation: Helsinki University Hospital, Women's Hospital
name: Saila SB Koivusalo
role: PRINCIPAL_INVESTIGATOR
References: