NCT03765684

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Dec 2018Dec 2026

Study Start

First participant enrolled

December 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

4.1 years

First QC Date

December 3, 2018

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neonatal body fat %

    Measured with PEA POD Cosmed® Infant Body Composition Assessment system

    Within 72 hours of birth

Secondary Outcomes (4)

  • Newborn weight

    Within 2 hours of birth

  • Newborn height

    Within 2 hours of birth

  • ASQ-3

    3 months, 1 year and 2 years of age

  • ITSEA

    3 months, 1 year and 2 years of age

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Inability to communicate in Finnish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUS Women's hospital, Helsinki Unversity Hospital

Helsinki, 00029, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal and umbilical cord blood sample is collected and stored for later analysis

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saila SB Koivusalo

    Helsinki University Hospital, Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Development Manager

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 5, 2018

Study Start

December 1, 2018

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations