Offspring, AdultHeBiCoNCT03765684
Factors Affecting Newborn Body Composition and Later Health in Helsinki Birth Cohort 2018-2022
An observational study of Offspring, Adult and Lifestyle, run by Helsinki University Central Hospital at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Offspring, Adult, Lifestyle, Obesity, Childhood
- How many people
- 600 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District.
Who cannot join
- Inability to communicate in Finnish language
Trial locations and contacts
1 site in 1 country.
Finland1 site
HUS Women's hospital, Helsinki Unversity Hospital
Helsinki, 00029
About this study
Official title: Effects of Various Parental and Gestational Factors on Offspring Body Composition and Health in Later Life in Helsinki Birth Cohort 2018-2022
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.
Read the 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.
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal body fat %
Measured with PEA POD Cosmed® Infant Body Composition Assessment system
Measured: Within 72 hours of birth
Secondary outcomes (4)
Newborn weight
Birth weight in kilograms
Measured: Within 2 hours of birth
Newborn height
Birth height in meters
Measured: Within 2 hours of birth
ASQ-3
Ages and Stages Questionnaire-3
Measured: 3 months, 1 year and 2 years of age
ITSEA
Infant Toddler Social Emotional Assessment
Measured: 3 months, 1 year and 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Dec 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Offspring, AdultStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Finnish Institute for Health and Welfare, UKK Institute
- Responsible party
- Principal investigator, Saila Koivusalo, Helsinki University Central Hospital
- Investigators
- Saila SB Koivusalo, Principal investigator, Helsinki University Hospital, Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765684
- Sponsor's protocol ID
- HUS/180/2018, HUS/512/2019
- Acronym
- HeBiCo
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2018
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Parental and Gestational Factors on Offspring Body Composition and Health in Later Life in Helsinki Birth Cohort 2018-2022
- ClinicalTrials.gov ID
- NCT03765684
- Acronym / sponsor ID
- HeBiCo / HUS/180/2018, HUS/512/2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Finnish Institute for Health and Welfare, UKK Institute
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District.
Key exclusion criteria (1 listed)
- Inability to communicate in Finnish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neonatal body fat %
Time frame: Within 72 hours of birth
Measured with PEA POD Cosmed® Infant Body Composition Assessment system
4 secondary outcomes
Newborn weight
Time frame: Within 2 hours of birth
Newborn height
Time frame: Within 2 hours of birth
ASQ-3
Time frame: 3 months, 1 year and 2 years of age
ITSEA
Time frame: 3 months, 1 year and 2 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saila SB Koivusalo principal investigator
Helsinki University Hospital, Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Offspring, Adult and Lifestyle, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal body fat % (time frame: Within 72 hours of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.