<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/NCT03239028</url>
  </required_header>
  <id_info>
    <org_study_id>2013-04 M-C Association</org_study_id>
    <nct_id>NCT03239028</nct_id>
  </id_info>
  <brief_title>Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy</brief_title>
  <official_title>Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy: 15 Years Follow up From a Large National Birth Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Fetal Programming, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Statens Serum Institut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Iceland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Fetal Programming, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We will examine the association between diet quality in offspring at age 14 years and&#xD;
      maternal diet quality during pregnancy in the Danish National Birth Cohort&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Dietary exposures in fetal life may have long lasting impact on the individual's&#xD;
      susceptibility for several non-communicable diseases. Although offspring's own dietary habits&#xD;
      become increasingly independent from parental influence other external factors are likely to&#xD;
      exist. Further insights are needed to interpret and separate potential influence from&#xD;
      exposures in pregnancy from later dietary habits on later disease risk.&#xD;
&#xD;
      Objectives: We will examine the association between diet quality in offspring at age 14 years&#xD;
      and maternal diet quality during pregnancy in the Danish National Birth Cohort (DNBC).&#xD;
&#xD;
      Design: A total of 19620 DNBC offspring-mother pairs will be matched by offspring dietary&#xD;
      intake assessed at age ~14 years with a 150-item food frequency questionnaire (FFQ) and&#xD;
      dietary intake assessed with a 300-item FFQ during mid-pregnancy (1996-2003). A Healthy&#xD;
      Eating Index (HEI) will be developed as an indicator for diet quality based on current Danish&#xD;
      Food-Based Dietary Guidelines including 8 components; fruit and vegetables, fish, dietary&#xD;
      fibers, red meat, saturated fatty acids, sodium, sugar-sweetened beverages, and added sugar.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Diet quality</measure>
    <time_frame>Reported intake during one year</time_frame>
    <description>Healthy Eating Index depicting diet quality</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">19620</enrollment>
  <condition>Eating Behavior</condition>
  <arm_group>
    <arm_group_label>Danish National Birth Cohort</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Observational</intervention_name>
    <arm_group_label>Danish National Birth Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Around 95,000 children born during 1996-2003 in Denmark were recruited for The Danish&#xD;
        National Birth Cohort&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants in the Danish National Birth Cohort&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If mother did not complete a food frequency questionnaire during pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sjurdur F Olsen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Statens Serum Institut</affiliation>
  </overall_official>
  <link>
    <url>http://www.cfp-research.com/</url>
    <description>Link to web-page of Centre for Fetal Programming</description>
  </link>
  <results_reference>
    <citation>Olsen J, Melbye M, Olsen SF, Sorensen TI, Aaby P, Andersen AM, Taxbol D, Hansen KD, Juhl M, Schow TB, Sorensen HT, Andresen J, Mortensen EL, Olesen AW, Sondergaard C. The Danish National Birth Cohort--its background, structure and aim. Scand J Public Health. 2001 Dec;29(4):300-7. doi: 10.1177/14034948010290040201.</citation>
    <PMID>11775787</PMID>
  </results_reference>
  <results_reference>
    <citation>Olsen SF, Mikkelsen TB, Knudsen VK, Orozova-Bekkevold I, Halldorsson TI, Strom M, Osterdal ML. Data collected on maternal dietary exposures in the Danish National Birth Cohort. Paediatr Perinat Epidemiol. 2007 Jan;21(1):76-86. doi: 10.1111/j.1365-3016.2007.00777.x.</citation>
    <PMID>17239183</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diet quality</keyword>
  <keyword>pregnancy</keyword>
  <keyword>adolescence</keyword>
  <keyword>longitudinal study</keyword>
  <keyword>food frequency questionnaire</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03239028
org study id: 2013-04 M-C Association
nct id: NCT03239028
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We will examine the association between diet quality in offspring at age 14 years and
      maternal diet quality during pregnancy in the Danish National Birth Cohort
Background: Dietary exposures in fetal life may have long lasting impact on the individual's
      susceptibility for several non-communicable diseases. Although offspring's own dietary habits
      become increasingly independent from parental influence other external factors are likely to
      exist. Further insights are needed to interpret and separate potential influence from
      exposures in pregnancy from later dietary habits on later disease risk.

      Objectives: We will examine the association between diet quality in offspring at age 14 years
      and maternal diet quality during pregnancy in the Danish National Birth Cohort (DNBC).

      Design: A total of 19620 DNBC offspring-mother pairs will be matched by offspring dietary
      intake assessed at age ~14 years with a 150-item food frequency questionnaire (FFQ) and
      dietary intake assessed with a 300-item FFQ during mid-pregnancy (1996-2003). A Healthy
      Eating Index (HEI) will be developed as an indicator for diet quality based on current Danish
      Food-Based Dietary Guidelines including 8 components; fruit and vegetables, fish, dietary
      fibers, red meat, saturated fatty acids, sodium, sugar-sweetened beverages, and added sugar.
observational model: Cohort
time perspective: Prospective
measure: Diet quality
time frame: Reported intake during one year
description: Healthy Eating Index depicting diet quality
arm group label: Danish National Birth Cohort
intervention type: Behavioral
intervention name: Observational
arm group label: Danish National Birth Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sjurdur F Olsen, PhD
role: Study Director
affiliation: Statens Serum Institut
url: http://www.cfp-research.com/
description: Link to web-page of Centre for Fetal Programming
citation: Olsen J, Melbye M, Olsen SF, Sorensen TI, Aaby P, Andersen AM, Taxbol D, Hansen KD, Juhl M, Schow TB, Sorensen HT, Andresen J, Mortensen EL, Olesen AW, Sondergaard C. The Danish National Birth Cohort--its background, structure and aim. Scand J Public Health. 2001 Dec;29(4):300-7. doi: 10.1177/14034948010290040201.
PMID: 11775787
citation: Olsen SF, Mikkelsen TB, Knudsen VK, Orozova-Bekkevold I, Halldorsson TI, Strom M, Osterdal ML. Data collected on maternal dietary exposures in the Danish National Birth Cohort. Paediatr Perinat Epidemiol. 2007 Jan;21(1):76-86. doi: 10.1111/j.1365-3016.2007.00777.x.
PMID: 17239183
responsible party type: Sponsor
sharing ipd: Undecided