<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/NCT03266497</url>
  </required_header>
  <id_info>
    <org_study_id>R01HL115189</org_study_id>
    <nct_id>NCT03266497</nct_id>
  </id_info>
  <brief_title>Diet Quality Among U.S.-Born and Foreign-born Non-Hispanic Blacks</brief_title>
  <official_title>Diet Quality Among U.S.-Born and Foreign-born Non-Hispanic Blacks: NHANES 2003-2012 Data</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sara C. Folta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tufts University</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 study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks&#xD;
      using pooled NHANES data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses the Alternative Healthy Eating Index-2010 (AHEI-2010) and Dietary Approach to&#xD;
      Stop Hypertension (DASH) scores to compare diet quality between U.S.-born (n=3,837) and&#xD;
      foreign-born (n=406) non-Hispanic Black adults aged 22-79y, based on pooled nationally&#xD;
      representative data (NHANES 2003-2012); as well as by length of U.S. residency. Association&#xD;
      between nativity and diet quality was done using multivariable-adjusted linear regression for&#xD;
      the continuous total diet quality scores and their components, or multinomial (polytomous)&#xD;
      logistic regression for categorical tertiles (low, medium, or high) of the total scores and&#xD;
      their components. The study found that foreign-born Blacks had significantly higher AHEI-2010&#xD;
      and DASH scores compared to U.S-born Blacks, and more favorable intakes for many of the score&#xD;
      components. Among foreign-born Blacks, diet quality did not significantly differ by length of&#xD;
      residency. Foreign-born Blacks were more likely to be in the high than low tertile for fruit&#xD;
      (including and excluding fruit juice), vegetables (excluding starchy vegetables), percent&#xD;
      whole grains, and omega-3 fatty acids. Overall, the study suggests that foreign-born Blacks&#xD;
      have better diet quality compared to their U.S.-born counterparts. Considering nativity among&#xD;
      U.S. Blacks in nutrition research and public health efforts may therefore improve accuracy of&#xD;
      characterizing dietary intakes and facilitate development of targeted nutrition interventions&#xD;
      to reduce diet-related diseases in the diverse Black population in the U.S.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2003</start_date>
  <completion_date type="Actual">December 2012</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>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adapted AHEI-2010</measure>
    <time_frame>2003-2012</time_frame>
    <description>Components include: fruit (excluding fruit juice) (s/d); vegetables (excluding white potatoes) (s/d); whole grains (oz-equivalents/d); sugar-sweetened beverages (s/d); nuts, legumes, and vegetable protein (oz-equivalents/d); red/processed meat (s/d); long-chain omega-3 fats (EPA+DHA; mg/d); polyunsaturated fats (PUFA; % kcal/d); sodium (mg/d); and alcohol (drinks/d). Potential range of 0-100 points and higher scores indicative of higher diet quality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adapted DASH score</measure>
    <time_frame>2003-2012</time_frame>
    <description>Quintile-, food-based dietary score assessing adherence to the DASH diet, which was developed as a dietary approach to prevent and treat hypertension. Components of the revised score include vegetables, fruit, whole grains, nuts and legumes, sodium, red and processed meat, and sugar-sweetened beverages.</description>
  </secondary_outcome>
  <enrollment type="Actual">4243</enrollment>
  <condition>Diet Habit</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population comprised 4,243 non-Hispanic Blacks, including 3,837 U.S.-born (90.4%)&#xD;
        and 406 foreign-born (9.6%). Compared to U.S.-born Blacks, a higher proportion of&#xD;
        foreign-born Blacks were male, had attained a higher level of education, were classified as&#xD;
        normal or overweight, had never been a smoker, engaged in physical activity, and had lower&#xD;
        energy intake. In comparison to those who were in the U.S. for &lt;10 years, more foreign-born&#xD;
        Blacks who were in the U.S. for ≥30 years were current smokers (14.8% vs. 5.0%,&#xD;
        respectively), had higher income (IPR of ≥4.00: 43.5% vs 7.9%, respectively), and a higher&#xD;
        percent with a college degree or higher (39.4% vs. 18.3%, respectively). Foreign-born&#xD;
        Blacks residing in the U.S. for ≥30 years reported higher BMI in comparison to those&#xD;
        residing in the U.S. for &lt;10 years (28.8 vs. 26.7 kg/m2).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  22-79&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant subjects&#xD;
&#xD;
          -  Energy intakes of ≤600 kcal and ≥ 4800 kcal&#xD;
&#xD;
          -  No dietary data available&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tufts University</investigator_affiliation>
    <investigator_full_name>Sara C. Folta</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>diet quality</keyword>
  <keyword>health disparities</keyword>
  <keyword>immigrants</keyword>
  <keyword>foreign-born</keyword>
  <keyword>Blacks/African Americans</keyword>
  <keyword>place of birth/nativity</keyword>
  <keyword>length of residency</keyword>
  <keyword>NHANES</keyword>
  <keyword>acculturation</keyword>
  <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/NCT03266497
org study id: R01HL115189
nct id: NCT03266497
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks
      using pooled NHANES data.
This study uses the Alternative Healthy Eating Index-2010 (AHEI-2010) and Dietary Approach to
      Stop Hypertension (DASH) scores to compare diet quality between U.S.-born (n=3,837) and
      foreign-born (n=406) non-Hispanic Black adults aged 22-79y, based on pooled nationally
      representative data (NHANES 2003-2012); as well as by length of U.S. residency. Association
      between nativity and diet quality was done using multivariable-adjusted linear regression for
      the continuous total diet quality scores and their components, or multinomial (polytomous)
      logistic regression for categorical tertiles (low, medium, or high) of the total scores and
      their components. The study found that foreign-born Blacks had significantly higher AHEI-2010
      and DASH scores compared to U.S-born Blacks, and more favorable intakes for many of the score
      components. Among foreign-born Blacks, diet quality did not significantly differ by length of
      residency. Foreign-born Blacks were more likely to be in the high than low tertile for fruit
      (including and excluding fruit juice), vegetables (excluding starchy vegetables), percent
      whole grains, and omega-3 fatty acids. Overall, the study suggests that foreign-born Blacks
      have better diet quality compared to their U.S.-born counterparts. Considering nativity among
      U.S. Blacks in nutrition research and public health efforts may therefore improve accuracy of
      characterizing dietary intakes and facilitate development of targeted nutrition interventions
      to reduce diet-related diseases in the diverse Black population in the U.S.
observational model: Other
time perspective: Cross-Sectional
measure: Adapted AHEI-2010
time frame: 2003-2012
description: Components include: fruit (excluding fruit juice) (s/d); vegetables (excluding white potatoes) (s/d); whole grains (oz-equivalents/d); sugar-sweetened beverages (s/d); nuts, legumes, and vegetable protein (oz-equivalents/d); red/processed meat (s/d); long-chain omega-3 fats (EPA+DHA; mg/d); polyunsaturated fats (PUFA; % kcal/d); sodium (mg/d); and alcohol (drinks/d). Potential range of 0-100 points and higher scores indicative of higher diet quality
measure: Adapted DASH score
time frame: 2003-2012
description: Quintile-, food-based dietary score assessing adherence to the DASH diet, which was developed as a dietary approach to prevent and treat hypertension. Components of the revised score include vegetables, fruit, whole grains, nuts and legumes, sodium, red and processed meat, and sugar-sweetened beverages.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Tufts University
investigator full name: Sara C. Folta
investigator title: Associate Professor
sharing ipd: No