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

NCT ID: NCT03765684

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Offspring, Adult Lifestyle Obesity, Childhood Pregnancy Related Child Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

Inability to communicate in Finnish language
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Helsinki

OTHER

Sponsor Role collaborator

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role collaborator

UKK Institute

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Saila Koivusalo

Associate Professor, Development Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saila SB Koivusalo

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Hospital, Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HUS Women's hospital, Helsinki Unversity Hospital

Helsinki, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUS/180/2018, HUS/512/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RESTORE - Phase II
NCT06349070 ENROLLING_BY_INVITATION NA
Healthy Baby Healthy Mother Toolkit
NCT06594419 RECRUITING NA