<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/NCT03297970</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00043252</org_study_id>
    <nct_id>NCT03297970</nct_id>
  </id_info>
  <brief_title>Bogota School Children Cohort</brief_title>
  <acronym>BoSCCo</acronym>
  <official_title>Bogota School Children Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad de la Sabana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foundation for Research in Nutrition and Health (FINUSAD)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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>
      This observational study investigates the associations of nutritional indicators, biomarkers,&#xD;
      sociodemographic conditions, and infections with child health, as well as physical,&#xD;
      behavioral, and cognitive development. Investigators recruited a random sample of 3202&#xD;
      children from primary public schools in Bogota, Colombia in February 2006 and followed them&#xD;
      for a median of 6.5 years. Investigators hypothesized that poor nutritional status at the&#xD;
      time of recruitment in middle childhood would be related to adverse health outcomes through&#xD;
      adolescence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2006</start_date>
  <completion_date type="Actual">August 11, 2015</completion_date>
  <primary_completion_date type="Actual">August 11, 2015</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>Externalizing behavior problems</measure>
    <time_frame>Assessed at one point in time when the children were 11-18 years old.</time_frame>
    <description>Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire. The YSR is a self-administered questionnaire consisting of 112 statements addressing behaviors or feelings that adolescents rate as false, sometimes true, or very/often true. From responses to these questions, an Assessment Data Manager (ADM) software calculates continuous scores for aggressive behavior and rule breaking behavior. The sum of the aggressive and rule breaking behavior subscale scores constitute the total externalizing problems score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Internalizing behavior problems</measure>
    <time_frame>Assessed at one point in time when the children were 11-18 years old.</time_frame>
    <description>Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire. The sum of the anxious/depressed, withdrawn/depressed, and somatic complaint subscale scores constitute the total internalizing problems score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavior problem subscale scores (aggressive behavior, rule breaking behavior, anxious/depressed, withdrawn/depressed, somatic complaints, attention problems, social problems, and thought problems)</measure>
    <time_frame>Assessed at one point in time when the children were 11-18 years old.</time_frame>
    <description>Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body mass index change</measure>
    <time_frame>Median 6.5 years from recruitment</time_frame>
    <description>Change in body mass index for age Z-score from baseline to the last follow-up visit</description>
  </other_outcome>
  <other_outcome>
    <measure>Linear growth</measure>
    <time_frame>Median 6.5 years from recruitment</time_frame>
    <description>Change in height for age Z-score from baseline to the last follow-up visit</description>
  </other_outcome>
  <other_outcome>
    <measure>Age at menarche</measure>
    <time_frame>Median 6.5 years from recruitment</time_frame>
    <description>Reported age at first menstrual period</description>
  </other_outcome>
  <other_outcome>
    <measure>Grade repetition</measure>
    <time_frame>5 years</time_frame>
    <description>Outcome of school grades between 2006-2011</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Median 6.5 years from recruitment</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3202</enrollment>
  <condition>Nutrition</condition>
  <condition>Child Health</condition>
  <condition>Child Growth</condition>
  <condition>Neurocognitive Development</condition>
  <condition>Sexual Maturation</condition>
  <condition>Infectious Morbidity</condition>
  <condition>Behavior Problem</condition>
  <arm_group>
    <arm_group_label>Bogota School Children Cohort</arm_group_label>
    <description>Children are classified according to exposure levels of:&#xD;
Micronutrient biomarker indicators:&#xD;
Ferritin&#xD;
Hemoglobin&#xD;
Mean corpuscular volume&#xD;
Zinc&#xD;
Vitamin A&#xD;
Vitamin B12&#xD;
Folate&#xD;
Vitamin D&#xD;
Serum fatty acids&#xD;
Inflammatory biomarkers:&#xD;
C-reactive protein&#xD;
Diet&#xD;
Socioeconomic status indicators&#xD;
Anthropometric indicators&#xD;
Incidence of infectious morbidity symptoms&#xD;
DNA biomarkers</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, plasma, serum, and DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children were selected from primary public schools in Bogota, Colombia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary public school enrollment in February 2006&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Eduardo Villamor, MD MPH DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FINUSAD - Foundation for Research in Nutrition and Health</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of La Sabana</name>
      <address>
        <city>Chia</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Eduardo Villamor</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</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/NCT03297970
org study id: HUM00043252
nct id: NCT03297970
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study investigates the associations of nutritional indicators, biomarkers,
      sociodemographic conditions, and infections with child health, as well as physical,
      behavioral, and cognitive development. Investigators recruited a random sample of 3202
      children from primary public schools in Bogota, Colombia in February 2006 and followed them
      for a median of 6.5 years. Investigators hypothesized that poor nutritional status at the
      time of recruitment in middle childhood would be related to adverse health outcomes through
      adolescence.
observational model: Cohort
time perspective: Prospective
measure: Externalizing behavior problems
time frame: Assessed at one point in time when the children were 11-18 years old.
description: Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire. The YSR is a self-administered questionnaire consisting of 112 statements addressing behaviors or feelings that adolescents rate as false, sometimes true, or very/often true. From responses to these questions, an Assessment Data Manager (ADM) software calculates continuous scores for aggressive behavior and rule breaking behavior. The sum of the aggressive and rule breaking behavior subscale scores constitute the total externalizing problems score.
measure: Internalizing behavior problems
time frame: Assessed at one point in time when the children were 11-18 years old.
description: Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire. The sum of the anxious/depressed, withdrawn/depressed, and somatic complaint subscale scores constitute the total internalizing problems score.
measure: Behavior problem subscale scores (aggressive behavior, rule breaking behavior, anxious/depressed, withdrawn/depressed, somatic complaints, attention problems, social problems, and thought problems)
time frame: Assessed at one point in time when the children were 11-18 years old.
description: Adolescent behavior problems were ascertained with the Youth Self Report (YSR) questionnaire.
measure: Body mass index change
time frame: Median 6.5 years from recruitment
description: Change in body mass index for age Z-score from baseline to the last follow-up visit
measure: Linear growth
time frame: Median 6.5 years from recruitment
description: Change in height for age Z-score from baseline to the last follow-up visit
measure: Age at menarche
time frame: Median 6.5 years from recruitment
description: Reported age at first menstrual period
measure: Grade repetition
time frame: 5 years
description: Outcome of school grades between 2006-2011
measure: Blood pressure
time frame: Median 6.5 years from recruitment
arm group label: Bogota School Children Cohort
description: Children are classified according to exposure levels of:
Micronutrient biomarker indicators:
Ferritin
Hemoglobin
Mean corpuscular volume
Zinc
Vitamin A
Vitamin B12
Folate
Vitamin D
Serum fatty acids
Inflammatory biomarkers:
C-reactive protein
Diet
Socioeconomic status indicators
Anthropometric indicators
Incidence of infectious morbidity symptoms
DNA biomarkers
Whole blood, plasma, serum, and DNA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
last name: Eduardo Villamor, MD MPH DrPH
role: Principal Investigator
affiliation: University of Michigan
facility: 
facility: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Eduardo Villamor
investigator title: Professor
mesh term: Problem Behavior
sharing ipd: No