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

Pregnancy Related Clinical Trial

— HeBiCo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03765684
• Other study ID #: HUS/180/2018, HUS/512/2019
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Helsinki University Central Hospital
• Contact: Saila SB Koivusalo
• Phone: +358407250620
• Email: saila.koivusalo[@]hus.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Inability to communicate in Finnish language

Related Conditions & MeSH terms

• Child Development
• Lifestyle
• Obesity, Childhood
• Offspring, Adult
• Pediatric Obesity
• Pregnancy Related

Locations

Country	Name	City	State
Finland	HUS Women's hospital, Helsinki Unversity Hospital	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Finnish Institute for Health and Welfare, UKK Institute, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal body fat %	Measured with PEA POD Cosmed® Infant Body Composition Assessment system	Within 72 hours of birth
Secondary	Newborn weight	Birth weight in kilograms	Within 2 hours of birth
Secondary	Newborn height	Birth height in meters	Within 2 hours of birth
Secondary	ASQ-3	Ages and Stages Questionnaire-3	3 months, 1 year and 2 years of age
Secondary	ITSEA	Infant Toddler Social Emotional Assessment	3 months, 1 year and 2 years of age