<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/NCT03254615</url>
  </required_header>
  <id_info>
    <org_study_id>016/2017</org_study_id>
    <nct_id>NCT03254615</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Water Consume in Child</brief_title>
  <acronym>ECCA001LCE</acronym>
  <official_title>Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Percentage of Water Consumed Among Early Elementary School Students With a 1-year Follow up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jose Francisco Gonzalez-Zamora</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Pediatrics, Mexico</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The current project seeks to evaluate the effectiveness of numerous educational strategy&#xD;
      interventions to increase the percentage of water consumed among early elementary school&#xD;
      students over a 1-year period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A community intervention trial will be conducted at four public elementary schools of the&#xD;
      Coyoacan Delegation in Mexico City. It will include healthy first graders during the&#xD;
      2017-2018 school year whose parents agree to participate through verbal informed consent and&#xD;
      a signed privacy notice. These parents will complete a baseline 3-day beverage record (two&#xD;
      weekdays and one weekend day). The four schools will be assigned to one of three groups:&#xD;
      Group I will receive the educational strategy during the first grade; Group II will receive&#xD;
      it during first and second grades; and Group III will receive it during the first, second,&#xD;
      and third grades. All schools will have water dispensers inside the classrooms, and the&#xD;
      children will receive a reusable 600-mL bottle so they are able to consume water on demand&#xD;
      throughout the day. A second record of beverage consumption will be obtained by completing&#xD;
      multiple interventions within each group, and a third record will be completed 1 year later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 13, 2018</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of water consumed</measure>
    <time_frame>Up to 4 years, baseline measurement and once a year</time_frame>
    <description>Changes in average water consumption/ total liquid consumption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Water consumption</measure>
    <time_frame>Up to 4 years, baseline measurement and once a year</time_frame>
    <description>Changes in the average of water consumption per child over a 3-day period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total liquid Consumption</measure>
    <time_frame>Up to 4 years, baseline measurement and once a year</time_frame>
    <description>Changes in the average of total liquids consumed per child over a 3-day period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of educational strategy</measure>
    <time_frame>Up to 4 years, baseline measurement and once a year</time_frame>
    <description>Changes in the percentage of water consumed, 1 year after completing the interventions within each group relative to baseline measurement</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>Up to 4 years, baseline measurement and once a year</time_frame>
    <description>Indicator of the relationship between weight and height</description>
  </other_outcome>
  <other_outcome>
    <measure>Health condition</measure>
    <time_frame>Up to 4 years, baseline measurement and once a year</time_frame>
    <description>Health condition that (in the opinion of the investigator) enables the participant to have free consumption of water</description>
  </other_outcome>
  <other_outcome>
    <measure>Water consumption per school</measure>
    <time_frame>Up to 4 years, baseline measurement and on monthly bases</time_frame>
    <description>Quantity of water consumed in 1 month per participating school</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">329</enrollment>
  <condition>Water Consumption</condition>
  <condition>Healthy Lifestyle</condition>
  <condition>Elementary School</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group I will receive &quot;I Prefer Plain Water&quot; only during the first grade</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group II will receive &quot;I Prefer Plain Water&quot; during first and second grades</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group III will receive &quot;I Prefer Plain Water&quot; during first, second, and third grades</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;I Prefer Plain Water&quot;</intervention_name>
    <description>The students will receive four educational sessions of approximately 1 hour. These sessions will be given every 2 weeks, and some will be supervised by a nutritionist.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy children&#xD;
&#xD;
          -  Both girls and boys&#xD;
&#xD;
          -  Children whose parents agree to participation in the study through verbal informed&#xD;
             consent&#xD;
&#xD;
          -  Children whose parents sign a privacy notice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who present with any pathology that interferes with the free consumption of&#xD;
             water or with the proper execution of the study&#xD;
&#xD;
          -  Children for whom it is not possible to obtain a baseline record of beverage&#xD;
             consumption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose F Gonzalez-Zamora, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Pediatria</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jose F Gonzalez-Zamora, MD MSc</last_name>
    <phone>+525550687256</phone>
    <email>jf.gonzalezzamora@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claudia Pimentel-Hernández, MD MSc</last_name>
    <phone>+525554531524</phone>
    <email>clauspim@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto Nacional de Pediatria</name>
      <address>
        <city>Ciudad de Mexico</city>
        <state>Coyoacan</state>
        <zip>04530</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Pediatrics, Mexico</investigator_affiliation>
    <investigator_full_name>Jose Francisco Gonzalez-Zamora</investigator_full_name>
    <investigator_title>M.D. MSc</investigator_title>
  </responsible_party>
  <keyword>Plain water</keyword>
  <keyword>Educative strategies</keyword>
  <keyword>Effectiveness</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03254615/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03254615
org study id: 016/2017
nct id: NCT03254615
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The current project seeks to evaluate the effectiveness of numerous educational strategy
      interventions to increase the percentage of water consumed among early elementary school
      students over a 1-year period.
A community intervention trial will be conducted at four public elementary schools of the
      Coyoacan Delegation in Mexico City. It will include healthy first graders during the
      2017-2018 school year whose parents agree to participate through verbal informed consent and
      a signed privacy notice. These parents will complete a baseline 3-day beverage record (two
      weekdays and one weekend day). The four schools will be assigned to one of three groups:
      Group I will receive the educational strategy during the first grade; Group II will receive
      it during first and second grades; and Group III will receive it during the first, second,
      and third grades. All schools will have water dispensers inside the classrooms, and the
      children will receive a reusable 600-mL bottle so they are able to consume water on demand
      throughout the day. A second record of beverage consumption will be obtained by completing
      multiple interventions within each group, and a third record will be completed 1 year later.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.
primary purpose: Other
masking: None (Open Label)
measure: Percentage of water consumed
time frame: Up to 4 years, baseline measurement and once a year
description: Changes in average water consumption/ total liquid consumption
measure: Water consumption
time frame: Up to 4 years, baseline measurement and once a year
description: Changes in the average of water consumption per child over a 3-day period
measure: Total liquid Consumption
time frame: Up to 4 years, baseline measurement and once a year
description: Changes in the average of total liquids consumed per child over a 3-day period
measure: Effectiveness of educational strategy
time frame: Up to 4 years, baseline measurement and once a year
description: Changes in the percentage of water consumed, 1 year after completing the interventions within each group relative to baseline measurement
measure: BMI
time frame: Up to 4 years, baseline measurement and once a year
description: Indicator of the relationship between weight and height
measure: Health condition
time frame: Up to 4 years, baseline measurement and once a year
description: Health condition that (in the opinion of the investigator) enables the participant to have free consumption of water
measure: Water consumption per school
time frame: Up to 4 years, baseline measurement and on monthly bases
description: Quantity of water consumed in 1 month per participating school
arm group label: Group 1
arm group type: Experimental
description: Group I will receive "I Prefer Plain Water" only during the first grade
arm group label: Group 2
arm group type: Experimental
description: Group II will receive "I Prefer Plain Water" during first and second grades
arm group label: Group 3
arm group type: Experimental
description: Group III will receive "I Prefer Plain Water" during first, second, and third grades
intervention type: Behavioral
intervention name: "I Prefer Plain Water"
description: The students will receive four educational sessions of approximately 1 hour. These sessions will be given every 2 weeks, and some will be supervised by a nutritionist.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
criteria: 
gender: All
minimum age: 5 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jose F Gonzalez-Zamora, MD MSc
role: Principal Investigator
affiliation: Instituto Nacional de Pediatria
last name: Jose F Gonzalez-Zamora, MD MSc
phone: +525550687256
email: jf.gonzalezzamora@gmail.com
last name: Claudia Pimentel-Hernández, MD MSc
phone: +525554531524
email: clauspim@hotmail.com
facility: 
status: Recruiting
country: Mexico
responsible party type: Sponsor-Investigator
investigator affiliation: National Institute of Pediatrics, Mexico
investigator full name: Jose Francisco Gonzalez-Zamora
investigator title: M.D. MSc
sharing ipd: No
provided document: 