<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/NCT03261882</url>
  </required_header>
  <id_info>
    <org_study_id>NHANES</org_study_id>
    <secondary_id>1T32HL129969-01A1</secondary_id>
    <secondary_id>R24HD050924</secondary_id>
    <secondary_id>K01DK107791</secondary_id>
    <nct_id>NCT03261882</nct_id>
  </id_info>
  <brief_title>Loss of a Healthy Weight Advantage Among Mexican-American Children</brief_title>
  <official_title>Loss of a Healthy Weight Advantage Among Foreign-born Children of Mexican Origin: Analysis of Overweight/Obesity Trends From 1988-1994 to 2005-2014</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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>
      Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage&#xD;
      relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be&#xD;
      changing over time. The objective of this study was to examine whether the relationship&#xD;
      between nativity and overweight/obesity has changed over time among Mexican-American children&#xD;
      and to investigate the implications of this pattern on overweight/obesity disparities&#xD;
      relative to non-Hispanic Whites. Using cross-sectional data from Mexican-Americans and&#xD;
      non-Hispanic white children ages 4-17 years participating in the National Health and&#xD;
      Nutrition Examination Surveys (1988-1994 (N=4,718) and 2005-2014 (N=7,269), the investigators&#xD;
      used log-binomial regression to calculate prevalence ratios (PR) of overweight/obesity by&#xD;
      nativity status adjusting for age, sex, householder marital status, householder education,&#xD;
      survey period and a nativity by survey period interaction. The investigators also tested&#xD;
      another covariate-adjusted model with a 3-level ethnicity-nativity variable that included&#xD;
      Whites and an ethnicity-nativity by survey period interaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>overweight/obesity</measure>
    <time_frame>1988-1994 and 2005-2014</time_frame>
    <description>Body mass index (BMI) was calculated by dividing weight (kg) by height2 (m2), and overweight/obesity was defined as a BMI at or above the age- and sex-specific 85th percentile based on the CDC's BMI-for-age growth charts (yes/no).</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">11987</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Foreign-born Mexican-Americans</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>US-born Mexican-Americans</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>non-Hispanic Whites</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nativity</intervention_name>
    <description>Mexican-American children were subdivided into two groups based on their country of birth. Mexican-American children who were not born in the U.S. were considered foreign-born and those born in the U.S. were U.S.-born.</description>
    <arm_group_label>Foreign-born Mexican-Americans</arm_group_label>
    <arm_group_label>US-born Mexican-Americans</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data came from the National Health and Nutrition Examination Surveys (NHANES), a series of&#xD;
        repeated cross-sectional surveys conducted by the U.S. Centers for Disease Control and&#xD;
        Prevention. The investigators used data from NHANES III (1988-1994) and 5 pooled survey&#xD;
        cycles from the continuous NHANES (2005-2014) to represent the two survey periods under&#xD;
        study over 20 years apart. These analyses were restricted to Mexican-Americans and&#xD;
        non-Hispanic White children aged 4-17 years. Out of the 12,006 Mexican-Americans and white&#xD;
        children who attended the clinical examination in NHANES III and the continuous NHANES&#xD;
        (2005-2014), those who reported being pregnant were excluded from analyses (N=19). Our&#xD;
        final analytic sample included 6,280 Mexican-Americans and 5,707 White children across the&#xD;
        two survey periods (2,704 Mexican-Americans and 2,014 White children in 1988-1994; 3,576&#xD;
        Mexican-Americans and 3,693 White children in 2005-2014)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mexican-Americans and white children who attended the clinical examination in NHANES&#xD;
             III and the continuous NHANES&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reported being pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT03261882
org study id: NHANES
secondary id: 1T32HL129969-01A1
secondary id: R24HD050924
secondary id: K01DK107791
nct id: NCT03261882
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage
      relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be
      changing over time. The objective of this study was to examine whether the relationship
      between nativity and overweight/obesity has changed over time among Mexican-American children
      and to investigate the implications of this pattern on overweight/obesity disparities
      relative to non-Hispanic Whites. Using cross-sectional data from Mexican-Americans and
      non-Hispanic white children ages 4-17 years participating in the National Health and
      Nutrition Examination Surveys (1988-1994 (N=4,718) and 2005-2014 (N=7,269), the investigators
      used log-binomial regression to calculate prevalence ratios (PR) of overweight/obesity by
      nativity status adjusting for age, sex, householder marital status, householder education,
      survey period and a nativity by survey period interaction. The investigators also tested
      another covariate-adjusted model with a 3-level ethnicity-nativity variable that included
      Whites and an ethnicity-nativity by survey period interaction.
observational model: Other
time perspective: Cross-Sectional
measure: overweight/obesity
time frame: 1988-1994 and 2005-2014
description: Body mass index (BMI) was calculated by dividing weight (kg) by height2 (m2), and overweight/obesity was defined as a BMI at or above the age- and sex-specific 85th percentile based on the CDC's BMI-for-age growth charts (yes/no).
arm group label: Foreign-born Mexican-Americans
arm group label: US-born Mexican-Americans
arm group label: non-Hispanic Whites
intervention type: Other
intervention name: Nativity
description: Mexican-American children were subdivided into two groups based on their country of birth. Mexican-American children who were not born in the U.S. were considered foreign-born and those born in the U.S. were U.S.-born.
arm group label: Foreign-born Mexican-Americans
arm group label: US-born Mexican-Americans
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
sharing ipd: No