<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/NCT03243253</url>
  </required_header>
  <id_info>
    <org_study_id>CDC</org_study_id>
    <nct_id>NCT03243253</nct_id>
  </id_info>
  <brief_title>The Association of Fast Food Densities With Mortality From Cardiovascular Disease</brief_title>
  <official_title>The Association of Fast Food and Full Service Restaurant Densities With Mortality From Cardiovascular Disease and Stroke, and the Prevalence of Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Sciences</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>
      In this cross sectional study, county level data for CVD and stroke mortality, and prevalence&#xD;
      of T2D, were combined with per capita densities of FFR and FSR and analysed using multiple&#xD;
      and simple linear regression. Mortality and diabetes prevalence were corrected for poverty,&#xD;
      ethnicity, education, physical inactivity and smoking to reduce confounding effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the investigators used data on mortality rate (per 100,000 individuals) for CVD and stroke&#xD;
      (between 2011 and 2013, age&gt;35years) from the publicly available Centers for disease&#xD;
      prevention and control (CDC) web site (www.cdc.gov). CVD mortality was defined as the number&#xD;
      of deaths per 100,000 person-years due to circulatory causes (International Statistical&#xD;
      Classification of Diseases, Tenth Revision, codes I00-I99). Detailed information on&#xD;
      preparation, definition, download and sorting of data on prevalence of T2D (age-adjusted),&#xD;
      poverty and ethnicity have been explained elsewhere. In brief, county level data on the&#xD;
      prevalence of T2D were downloaded from the USA CDC web site (www.cdc.gov). Data on T2D was&#xD;
      estimated using data from the CDC Behavioural Risk Factor Surveillance System (BRFSS) which&#xD;
      is a monthly state based telephone survey of a nationally representative sample of adults&#xD;
      aged &gt;20 years old. In 2012, the year for which these data were downloaded, the survey&#xD;
      included landline telephones only and hence excluded individuals living in care homes or&#xD;
      those without a landline telephone. More than 400,000 individuals are contacted annually to&#xD;
      take part in the survey which has been running since 1984. Individuals are judged to have&#xD;
      diabetes if they respond 'yes;' to the question &quot;Has a doctor ever told participants that you&#xD;
      have diabetes?&quot;, excluding females who indicate in a follow-up question that they only had&#xD;
      diabetes during pregnancy. Previous work indicates that self-report of a physician's prior&#xD;
      diagnosis of diabetes is highly reliable compared to medical records. This question does not&#xD;
      separate those with type 1 and T2D. In the adult population of the USA more than 96% of&#xD;
      diabetes is type 2, the investigators therefore called the estimated prevalence that of T2D.&#xD;
      Given the magnitudes of the trends described here they cannot be attributed to differences in&#xD;
      prevalence of the type 1 diabetes. Data on rate of mortality (per 100,000 individuals) from&#xD;
      CVD and stroke (between 2011 and 2013, age&gt;35years) were also downloaded from CDC web site&#xD;
      (www.cdc.gov, National Vital Statistics System and National Centre for Health Statistics). A&#xD;
      previous variogram analysis has established that counties are an appropriate spatial level at&#xD;
      which to explore the associations of factors to T2D prevalence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">February 1, 2013</completion_date>
  <primary_completion_date type="Actual">January 1, 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>association between densities of fast food (FFR) and full service restaurants (FSR) with mortality from CVD and stroke, and the prevalence of type 2 diabetes (T2D).</measure>
    <time_frame>2011 to 2013</time_frame>
    <description>association between densities of fast food (FFR) and full service restaurants (FSR) with mortality from CVD and stroke, and the prevalence of type 2 diabetes (T2D).</description>
  </primary_outcome>
  <enrollment type="Actual">17000000</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>all the data collection have done by CDC.</intervention_name>
    <description>In this study there was no intervention, just simple data collection via CDC.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We used data on mortality rate (per 100,000 individuals) for CVD and stroke (between 2011&#xD;
        and 2013, age&gt;35years) from the publicly available Centers for disease prevention and&#xD;
        control (CDC) web site (www.cdc.gov).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age&gt;35 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://www.cdc.gov</url>
    <description>CDC website</description>
  </link>
  <results_reference>
    <citation>Mazidi M, Speakman JR. Higher densities of fast-food and full-service restaurants are not associated with obesity prevalence. Am J Clin Nutr. 2017 Aug;106(2):603-613. doi: 10.3945/ajcn.116.151407. Epub 2017 May 31.</citation>
    <PMID>28566310</PMID>
  </results_reference>
  <results_reference>
    <citation>Speakman JR, Heidari-Bakavoli S. Type 2 diabetes, but not obesity, prevalence is positively associated with ambient temperature. Sci Rep. 2016 Aug 1;6:30409. doi: 10.1038/srep30409.</citation>
    <PMID>27477955</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Sciences</investigator_affiliation>
    <investigator_full_name>John Speakman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all of our data are in public available, www.CDC.org</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>2011 to 2013</ipd_time_frame>
    <ipd_access_criteria>there is nor criteria for the sharing these data.</ipd_access_criteria>
  </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/NCT03243253
org study id: CDC
nct id: NCT03243253
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this cross sectional study, county level data for CVD and stroke mortality, and prevalence
      of T2D, were combined with per capita densities of FFR and FSR and analysed using multiple
      and simple linear regression. Mortality and diabetes prevalence were corrected for poverty,
      ethnicity, education, physical inactivity and smoking to reduce confounding effects.
the investigators used data on mortality rate (per 100,000 individuals) for CVD and stroke
      (between 2011 and 2013, age>35years) from the publicly available Centers for disease
      prevention and control (CDC) web site (www.cdc.gov). CVD mortality was defined as the number
      of deaths per 100,000 person-years due to circulatory causes (International Statistical
      Classification of Diseases, Tenth Revision, codes I00-I99). Detailed information on
      preparation, definition, download and sorting of data on prevalence of T2D (age-adjusted),
      poverty and ethnicity have been explained elsewhere. In brief, county level data on the
      prevalence of T2D were downloaded from the USA CDC web site (www.cdc.gov). Data on T2D was
      estimated using data from the CDC Behavioural Risk Factor Surveillance System (BRFSS) which
      is a monthly state based telephone survey of a nationally representative sample of adults
      aged >20 years old. In 2012, the year for which these data were downloaded, the survey
      included landline telephones only and hence excluded individuals living in care homes or
      those without a landline telephone. More than 400,000 individuals are contacted annually to
      take part in the survey which has been running since 1984. Individuals are judged to have
      diabetes if they respond 'yes;' to the question "Has a doctor ever told participants that you
      have diabetes?", excluding females who indicate in a follow-up question that they only had
      diabetes during pregnancy. Previous work indicates that self-report of a physician's prior
      diagnosis of diabetes is highly reliable compared to medical records. This question does not
      separate those with type 1 and T2D. In the adult population of the USA more than 96% of
      diabetes is type 2, the investigators therefore called the estimated prevalence that of T2D.
      Given the magnitudes of the trends described here they cannot be attributed to differences in
      prevalence of the type 1 diabetes. Data on rate of mortality (per 100,000 individuals) from
      CVD and stroke (between 2011 and 2013, age>35years) were also downloaded from CDC web site
      (www.cdc.gov, National Vital Statistics System and National Centre for Health Statistics). A
      previous variogram analysis has established that counties are an appropriate spatial level at
      which to explore the associations of factors to T2D prevalence.
observational model: Ecologic or Community
time perspective: Retrospective
measure: association between densities of fast food (FFR) and full service restaurants (FSR) with mortality from CVD and stroke, and the prevalence of type 2 diabetes (T2D).
time frame: 2011 to 2013
description: association between densities of fast food (FFR) and full service restaurants (FSR) with mortality from CVD and stroke, and the prevalence of type 2 diabetes (T2D).
intervention type: Other
intervention name: all the data collection have done by CDC.
description: In this study there was no intervention, just simple data collection via CDC.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://www.cdc.gov
description: CDC website
citation: Mazidi M, Speakman JR. Higher densities of fast-food and full-service restaurants are not associated with obesity prevalence. Am J Clin Nutr. 2017 Aug;106(2):603-613. doi: 10.3945/ajcn.116.151407. Epub 2017 May 31.
PMID: 28566310
citation: Speakman JR, Heidari-Bakavoli S. Type 2 diabetes, but not obesity, prevalence is positively associated with ambient temperature. Sci Rep. 2016 Aug 1;6:30409. doi: 10.1038/srep30409.
PMID: 27477955
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Sciences
investigator full name: John Speakman
investigator title: Principal Investigator
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: all of our data are in public available, www.CDC.org
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 2011 to 2013
ipd access criteria: there is nor criteria for the sharing these data.