<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/NCT02226627</url>
  </required_header>
  <id_info>
    <org_study_id>ELANS-2014</org_study_id>
    <nct_id>NCT02226627</nct_id>
  </id_info>
  <brief_title>Latin American Survey of Nutrition and Health / Estudio Latinoamericano de Nutrición y Salud</brief_title>
  <official_title>Latin American Survey of Nutrition and Health / Estudio Latinoamericano de Nutrición y Salud</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mauro Fisberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Life Sciences Institute, Argentina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pontificia Universidad Catolica de Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pontificia Universidad Javeriana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad de Costa Rica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad San Francisco de Quito</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto de Investigacion Nutricional, Peru</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Central de Venezuela</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Infantil Sabará</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to make a proper scientific assessment on the dietary intake and physical&#xD;
      activity levels of a representative sample of the urban population of 8 Latin American&#xD;
      countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). The&#xD;
      study was based on complex, multistage sample design, stratified by conglomerates, being all&#xD;
      regions of each country represented, and random selection of main cities within each region&#xD;
      according to probability proportional to size method. Sample will be stratified by gender,&#xD;
      age (15 to 65 years old), and socioeconomic level. Socioeconomic levels will be balanced and&#xD;
      divided in three strata (high, medium and low) based on national indexes used in each&#xD;
      country. All the study sites are university-based and will adhere to a common study protocol&#xD;
      for training, implementation of fieldwork, data collection and management, and quality&#xD;
      control procedures to be performed simultaneously. All participants will be required to&#xD;
      provide a written informed consent. A pilot study at small scale will be performed in each&#xD;
      country in order to test procedures and tools involved in ELANS. Anthropometric variables,&#xD;
      including body weight, height, waist, hip and neck circumferences will be measured according&#xD;
      to a standardized protocol. Nutritional intake evaluation will be performed using two 24-hour&#xD;
      dietary recalls, with 'multiple pass' procedure and a food frequency questionnaire.&#xD;
      Nutritional data will be entered in Nutrition Data System for Research (NDS-R, Minnesota&#xD;
      University) after a harmonization process between local foods and NDSR database. Physical&#xD;
      activity and energy expenditure will be assessed by IPAQ-long version questionnaire and 7-day&#xD;
      accelerometry.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>overweight/obesity</measure>
    <time_frame>baseline</time_frame>
    <description>overweight/obesity will be assessed via anthropometric evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>energy intake</measure>
    <time_frame>2 food records will be applied with 7 days apart</time_frame>
    <description>Nutritional intake will be performed using two 24-hour dietary recalls, with 'multiple pass' procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>energy expenditure</measure>
    <time_frame>1 week</time_frame>
    <description>accelerometer measurement during 1 week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>snack intake</measure>
    <time_frame>2 food records will be applied with 7 days apart</time_frame>
    <description>snack intake will be evaluated using two 24-hour dietary recalls, with 'multiple pass' procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>beverage intake</measure>
    <time_frame>after 7 days</time_frame>
    <description>Beverage intake will be evaluated using a food frequency questionnaire</description>
  </secondary_outcome>
  <enrollment type="Actual">9000</enrollment>
  <condition>Dietary Habits</condition>
  <condition>Physical Activity</condition>
  <condition>Overweight and Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The sample will include subjects of both sexes, between 15 and 65 years old, considering&#xD;
        four age ranges (as see below), that belong to high, middle or low socioeconomic levels&#xD;
        (SEL), living in private households in the major cities and other relevant cities in terms&#xD;
        of population weight, according to the regions of each of the countries selected for the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  males and females&#xD;
&#xD;
          -  15 to 65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adolescents without assent and parent´s or legal guardian´s permission will be&#xD;
             excluded&#xD;
&#xD;
          -  Any adolescent or adult with mental and/or physical disability will be excluded.&#xD;
&#xD;
          -  Any adolescent or adult with a chronic or acute illness that may affect normal eating&#xD;
             behavior or energy expenditure will be excluded.&#xD;
&#xD;
          -  Pregnant and nursing women of a child younger than 6 months will be excluded.&#xD;
&#xD;
          -  Any adolescent or adult who is not able to read will be excluded.&#xD;
&#xD;
          -  Any adolescent or adult who is not present at or refuses to accept the second visit&#xD;
             will be excluded.&#xD;
&#xD;
          -  Any adolescent or adult living in any residential settings different from a household&#xD;
             (hospitals, regiments, homes, such as old-age homes, etc.) and mobile homes or&#xD;
             trailers are excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro Fisberg, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Pensi- Fundação Jose Luiz Setubal - Hospital Infantil Sabara</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Life Science Institute (ILSI)</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Pensi- Fundação Jose Luiz Setubal - Hospital Infantil Sabara</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departamento de Nutrición, Diabetes y Metabolismo, Centro de Nutrición Molecular y Enfermedades Crónicas - Pontificia Universidad Católica</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departamento de Nutrición y Bioquímica - Pontificia Universidad Javeriana</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departamento de Bioquímica - Escuela de Medicina - Universidad de Costa Rica</name>
      <address>
        <city>San José</city>
        <country>Costa Rica</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad San Francisco de Quito</name>
      <address>
        <city>Quito</city>
        <country>Ecuador</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigación Nutricional</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios del Desarrollo - Universidade Central da Venezuela (CENDES-UCV)/Fundación Bengoa</name>
      <address>
        <city>Caracas</city>
        <country>Venezuela</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Costa Rica</country>
    <country>Ecuador</country>
    <country>Peru</country>
    <country>Venezuela</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 6, 2016</last_update_submitted>
  <last_update_submitted_qc>September 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Infantil Sabará</investigator_affiliation>
    <investigator_full_name>Mauro Fisberg</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02226627
org study id: ELANS-2014
nct id: NCT02226627
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study aims to make a proper scientific assessment on the dietary intake and physical
      activity levels of a representative sample of the urban population of 8 Latin American
      countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). The
      study was based on complex, multistage sample design, stratified by conglomerates, being all
      regions of each country represented, and random selection of main cities within each region
      according to probability proportional to size method. Sample will be stratified by gender,
      age (15 to 65 years old), and socioeconomic level. Socioeconomic levels will be balanced and
      divided in three strata (high, medium and low) based on national indexes used in each
      country. All the study sites are university-based and will adhere to a common study protocol
      for training, implementation of fieldwork, data collection and management, and quality
      control procedures to be performed simultaneously. All participants will be required to
      provide a written informed consent. A pilot study at small scale will be performed in each
      country in order to test procedures and tools involved in ELANS. Anthropometric variables,
      including body weight, height, waist, hip and neck circumferences will be measured according
      to a standardized protocol. Nutritional intake evaluation will be performed using two 24-hour
      dietary recalls, with 'multiple pass' procedure and a food frequency questionnaire.
      Nutritional data will be entered in Nutrition Data System for Research (NDS-R, Minnesota
      University) after a harmonization process between local foods and NDSR database. Physical
      activity and energy expenditure will be assessed by IPAQ-long version questionnaire and 7-day
      accelerometry.
observational model: Case-Only
time perspective: Cross-Sectional
measure: overweight/obesity
time frame: baseline
description: overweight/obesity will be assessed via anthropometric evaluation
measure: energy intake
time frame: 2 food records will be applied with 7 days apart
description: Nutritional intake will be performed using two 24-hour dietary recalls, with 'multiple pass' procedure
measure: energy expenditure
time frame: 1 week
description: accelerometer measurement during 1 week
measure: snack intake
time frame: 2 food records will be applied with 7 days apart
description: snack intake will be evaluated using two 24-hour dietary recalls, with 'multiple pass' procedure
measure: beverage intake
time frame: after 7 days
description: Beverage intake will be evaluated using a food frequency questionnaire
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mauro Fisberg, MD PhD
role: Principal Investigator
affiliation: Instituto Pensi- Fundação Jose Luiz Setubal - Hospital Infantil Sabara
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Brazil
country: Chile
country: Colombia
country: Costa Rica
country: Ecuador
country: Peru
country: Venezuela
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Infantil Sabará
investigator full name: Mauro Fisberg
investigator title: MD, PhD
mesh term: Overweight