<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/NCT03274739</url>
  </required_header>
  <id_info>
    <org_study_id>Creal</org_study_id>
    <nct_id>NCT03274739</nct_id>
  </id_info>
  <brief_title>Maternal Diet, Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood</brief_title>
  <official_title>Maternal Mediterranean Diet During Pregnancy in Association to Longitudinal Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barcelona Institute for Global Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barcelona Institute for Global Health</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>
      This study focused on evaluating the association between adherence to the Mediterranean diet&#xD;
      during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic&#xD;
      risk in early-childhood. This study is part of a secondary data analysis of the INMA&#xD;
      (INfancia y Medio Ambiente-(Environment and Childhood)) Project.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2004</start_date>
  <completion_date type="Actual">January 18, 2017</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Offspring's body mass index z-score trajectories</measure>
    <time_frame>From birth to 4 years of age</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Child cardiometabolic risk score</measure>
    <time_frame>At 4 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2762</enrollment>
  <condition>Cardiometabolic Risk</condition>
  <condition>Growth</condition>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>Pregnant women</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study included pregnant women recruited between 2003 and 2008 in the four Spanish&#xD;
        regions of Asturias, Gipuzkoa, Sabadell and Valencia as part of the population-based INMA&#xD;
        (&quot;INfancia y Medio Ambiente&quot;) birth cohort study. The pregnant women were recruited during&#xD;
        prenatal visits in the 1st trimester of pregnancy at public health care centers or&#xD;
        hospitals. Mothers were afterwards followed at 3rd trimester, and their children later, and&#xD;
        at ages 6 months, 1 and 4 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  to be resident in one of the study areas&#xD;
&#xD;
          -  to be at least 16 years old&#xD;
&#xD;
          -  to have a singleton pregnancy&#xD;
&#xD;
          -  to wish to deliver in the reference hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  to not be fluent in Spanish or other regional languages.&#xD;
&#xD;
          -  to have followed a programme of assisted reproduction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Guxens M, Ballester F, Espada M, Fernandez MF, Grimalt JO, Ibarluzea J, Olea N, Rebagliato M, Tardon A, Torrent M, Vioque J, Vrijheid M, Sunyer J; INMA Project. Cohort Profile: the INMA--INfancia y Medio Ambiente--(Environment and Childhood) Project. Int J Epidemiol. 2012 Aug;41(4):930-40. doi: 10.1093/ije/dyr054. Epub 2011 Apr 5. No abstract available.</citation>
    <PMID>21471022</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Barcelona Institute for Global Health</investigator_affiliation>
    <investigator_full_name>Jordi Virgili</investigator_full_name>
    <investigator_title>Quality 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/NCT03274739
org study id: Creal
nct id: NCT03274739
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study focused on evaluating the association between adherence to the Mediterranean diet
      during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic
      risk in early-childhood. This study is part of a secondary data analysis of the INMA
      (INfancia y Medio Ambiente-(Environment and Childhood)) Project.
observational model: Cohort
time perspective: Prospective
measure: Offspring's body mass index z-score trajectories
time frame: From birth to 4 years of age
measure: Child cardiometabolic risk score
time frame: At 4 years
arm group label: Pregnant women
description: Pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Guxens M, Ballester F, Espada M, Fernandez MF, Grimalt JO, Ibarluzea J, Olea N, Rebagliato M, Tardon A, Torrent M, Vioque J, Vrijheid M, Sunyer J; INMA Project. Cohort Profile: the INMA--INfancia y Medio Ambiente--(Environment and Childhood) Project. Int J Epidemiol. 2012 Aug;41(4):930-40. doi: 10.1093/ije/dyr054. Epub 2011 Apr 5. No abstract available.
PMID: 21471022
responsible party type: Principal Investigator
investigator affiliation: Barcelona Institute for Global Health
investigator full name: Jordi Virgili
investigator title: Quality Manager
mesh term: Pediatric Obesity
sharing ipd: No