<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03765684</url>
  </required_header>
  <id_info>
    <org_study_id>HUS/180/2018, HUS/512/2019</org_study_id>
    <nct_id>NCT03765684</nct_id>
  </id_info>
  <brief_title>Factors Affecting Newborn Body Composition and Later Health in Helsinki Birth Cohort 2018-2022</brief_title>
  <acronym>HeBiCo</acronym>
  <official_title>Effects of Various Parental and Gestational Factors on Offspring Body Composition and Health in Later Life in Helsinki Birth Cohort 2018-2022</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Finnish Institute for Health and Welfare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UKK Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Helsinki Birth Cohort 2018-2022 a large, longitudinal and well-phenotyped birth cohort of&#xD;
      infants and their parents will be established. Mothers, fathers/spouses and their children in&#xD;
      Helsinki and Uusimaa Hospital District are recruited in the study and newborn composition of&#xD;
      the children born in Helsinki Women's Hospital will be measured. Data on maternal and&#xD;
      paternal diet quality, physical activity and depression during and after pregnancy will be&#xD;
      collected and data from the hospital and national registers will be collected. Health of&#xD;
      offspring and parents will be followed during their later life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Helsinki Birth Cohort 2018-2022 (HeBiCo) study is designed to find evidence between various&#xD;
      intrauterine exposures and offspring adiposity and later health. It will be examined how&#xD;
      different maternal (e.g. chronic diseases, ethnicity, BMI), and obstetric factors (e.g.&#xD;
      gestational weight gain, diagnoses during pregnancy) as well as parental lifestyle and&#xD;
      psychological aspects (e.g. diet quality, physical activity, depression and anxiety) are&#xD;
      associated with newborn body composition and later health (e.g. obesity and neurocognitive&#xD;
      health).&#xD;
&#xD;
      In the first phase of the study the participants are recruited on postnatal ward after&#xD;
      delivery. The umbilical cord blood sample will be collected of all the neonates. After a&#xD;
      consent the participants fill in the digital background, food frequency, depression and&#xD;
      physical activity questionnaires. If the parents do not give their consent, the umbilical&#xD;
      cord blood sample will be destroyed. Body composition of offspring will be assessed within 72&#xD;
      hours after birth. Registry data will be collected.&#xD;
&#xD;
      The second phase of the HeBiCo study is based on the HUS WomensHub treatment path and/or&#xD;
      Apotti platform. The second phase of the HeBiCo constitutes of the mother-child pairs (and&#xD;
      fathers/spouses) whose pregnancy can be followed from the early pregnancy to the end of the&#xD;
      pregnancy through treatment path. Body composition of offspring born in Helsinki Women's&#xD;
      Hospital will be assessed within 72 hours after birth.&#xD;
&#xD;
      The future studies will include 1) the intervention studies with digital service concept&#xD;
      through WomensHub platform, and 2) the follow-up studies of offspring and parents in later&#xD;
      life (to establish e.g. growth trajectories and later metabolic health of offspring).&#xD;
&#xD;
      The first phase of the HeBiCo study was registered 3/2018.&#xD;
&#xD;
      The second phase will be registered now.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal body fat %</measure>
    <time_frame>Within 72 hours of birth</time_frame>
    <description>Measured with PEA POD Cosmed® Infant Body Composition Assessment system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Newborn weight</measure>
    <time_frame>Within 2 hours of birth</time_frame>
    <description>Birth weight in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn height</measure>
    <time_frame>Within 2 hours of birth</time_frame>
    <description>Birth height in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASQ-3</measure>
    <time_frame>3 months, 1 year and 2 years of age</time_frame>
    <description>Ages and Stages Questionnaire-3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ITSEA</measure>
    <time_frame>3 months, 1 year and 2 years of age</time_frame>
    <description>Infant Toddler Social Emotional Assessment</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Offspring, Adult</condition>
  <condition>Lifestyle</condition>
  <condition>Obesity, Childhood</condition>
  <condition>Pregnancy Related</condition>
  <condition>Child Development</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal and umbilical cord blood sample is collected and stored for later analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The first phase of the Helsinki Birth Cohort (HeBiCo) will be constituted of all the&#xD;
        neonates whose body composition at birth can be obtained at Helsinki Women's Hospital, and&#xD;
        whose mothers and fathers/spouses fill out the questionnaires after delivery (background,&#xD;
        food frequency (FFQ), and depression questionnaires (EPDS, CES-D)).&#xD;
&#xD;
        In the second phase of HeBiCo, participants will be recruited any time during pregnancy and&#xD;
        also at postnatal ward after delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Mothers, fathers/spouses and offspring in Helsinki and Uusimaa Hospital District.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Inability to communicate in Finnish language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saila SB Koivusalo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki University Hospital, Women's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Saila SB Koivusalo</last_name>
    <phone>+358407250620</phone>
    <email>saila.koivusalo@hus.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heidi Sormunen-Harju</last_name>
    <phone>+358405603977</phone>
    <email>heidi.sormunen-harju@hus.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HUS Women's hospital, Helsinki Unversity Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heidi Sormunen-Harju, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Saila Koivusalo</investigator_full_name>
    <investigator_title>Associate Professor, Development Manager</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03765684
org study id: HUS/180/2018, HUS/512/2019
nct id: NCT03765684
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Neonatal body fat %
time frame: Within 72 hours of birth
description: Measured with PEA POD Cosmed® Infant Body Composition Assessment system
measure: Newborn weight
time frame: Within 2 hours of birth
description: Birth weight in kilograms
measure: Newborn height
time frame: Within 2 hours of birth
description: Birth height in meters
measure: ASQ-3
time frame: 3 months, 1 year and 2 years of age
description: Ages and Stages Questionnaire-3
measure: ITSEA
time frame: 3 months, 1 year and 2 years of age
description: Infant Toddler Social Emotional Assessment
Maternal and umbilical cord blood sample is collected and stored for later analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Saila SB Koivusalo
role: Principal Investigator
affiliation: Helsinki University Hospital, Women's Hospital
last name: Saila SB Koivusalo
phone: +358407250620
email: saila.koivusalo@hus.fi
last name: Heidi Sormunen-Harju
phone: +358405603977
email: heidi.sormunen-harju@hus.fi
facility: 
status: Recruiting
contact: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Saila Koivusalo
investigator title: Associate Professor, Development Manager
mesh term: Pediatric Obesity
sharing ipd: No