<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/NCT01715870</url>
  </required_header>
  <id_info>
    <org_study_id>4C-2012-04</org_study_id>
    <nct_id>NCT01715870</nct_id>
  </id_info>
  <brief_title>Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More</brief_title>
  <official_title>Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association for Innovation and Biomedical Research on Light and Image</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association for Innovation and Biomedical Research on Light and Image</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study population will be selected from the &quot;Epidemiological study on the prevalence of&#xD;
      Age related Macular Degeneration in Portugal&quot; (Protocol N. CC-01-2009) where retinal&#xD;
      photographic grading (current gold standard for AMD assessment) was performed to confirm AMD&#xD;
      diagnostic. This study provides a population-based sample in which precise and contemporary&#xD;
      information on the frequency of nutritional and lifestyle risk factors will be collected,&#xD;
      enabling to evaluate whether the separate and/or joint effects of these factors, if found&#xD;
      significant, are likely to have a major public health impact in terms of AMD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Life style and food habits questionnaire.</measure>
    <time_frame>2 years</time_frame>
    <description>Life style and food habits questionnaire. (This questionnaire assesses life style habits such as physical exercise and smoking habits and quantifies dietary intake.)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2000</enrollment>
  <condition>Age Related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Population of the &quot;Epidemiological study on AMD&quot;.</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Life style and food habits questionnaire</intervention_name>
    <arm_group_label>Population of the &quot;Epidemiological study on AMD&quot;.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects that participated in the &quot;Epidemiological study on the prevalence of Age related&#xD;
        Macular Degeneration in Portugal&quot; (Protocol N. CC-01-2009) will be invited to answer a&#xD;
        validated life style and food habits questionnaire.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects included in the Epidemiologic Study (Protocol N. CC-01-2009). (Subjects aged&#xD;
             over 55 years-old included in health care units of Mira or Lousã).&#xD;
&#xD;
          -  Written Informed Consent Form signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rufino M Silva, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Association for Innovation and Biomedical Research on Light and Image</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AIBILI</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-548</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 7, 2015</last_update_submitted>
  <last_update_submitted_qc>October 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Association for Innovation and Biomedical Research on Light and Image</investigator_affiliation>
    <investigator_full_name>Rufino Silva</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Age related macular degeneration</keyword>
  <keyword>Food habits</keyword>
  <keyword>Life style</keyword>
  <keyword>Risk factors</keyword>
  <keyword>questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_browse>
  <!-- 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/NCT01715870
org study id: 4C-2012-04
nct id: NCT01715870
lead sponsor: 
has dmc: No
The study population will be selected from the "Epidemiological study on the prevalence of
      Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) where retinal
      photographic grading (current gold standard for AMD assessment) was performed to confirm AMD
      diagnostic. This study provides a population-based sample in which precise and contemporary
      information on the frequency of nutritional and lifestyle risk factors will be collected,
      enabling to evaluate whether the separate and/or joint effects of these factors, if found
      significant, are likely to have a major public health impact in terms of AMD.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Life style and food habits questionnaire.
time frame: 2 years
description: Life style and food habits questionnaire. (This questionnaire assesses life style habits such as physical exercise and smoking habits and quantifies dietary intake.)
arm group label: Population of the "Epidemiological study on AMD".
intervention type: Behavioral
intervention name: Life style and food habits questionnaire
arm group label: Population of the "Epidemiological study on AMD".
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rufino M Silva, MD, PhD
role: Principal Investigator
affiliation: Association for Innovation and Biomedical Research on Light and Image
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Association for Innovation and Biomedical Research on Light and Image
investigator full name: Rufino Silva
investigator title: MD, PhD
mesh term: Macular Degeneration