<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/NCT04507100</url>
  </required_header>
  <id_info>
    <org_study_id>P86-19</org_study_id>
    <nct_id>NCT04507100</nct_id>
  </id_info>
  <brief_title>Comprehensive Analysis of the Program:Salud Escolar</brief_title>
  <official_title>Comprehensive Analysis of the Program:Salud Escolar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Salud Publica, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UNICEF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Education, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Salud Publica, 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 purpose of this study is to comprehensively evaluate Salud Escolar (School Health), a&#xD;
      program led by the Mexican Ministries of Health and Education. This comprehensive evaluation&#xD;
      considers a design, implementation, results, and impact evaluation of Salud Escolar.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims is to comprehensively analyze the design, implementation, results, and impact&#xD;
      of Salud Escolar, a program led by the Mexican Ministries of Health and Education, during the&#xD;
      first phase of implementation, from August 2020 to July 2021. Salud Escolar considers the&#xD;
      World Health Organization (WHO) health promoting framework to foster a healthy environment&#xD;
      and enhance children's physical activity, healthy eating and hydration. Salud Escolar&#xD;
      consists on several activities aligned in the following components: healthy eating, healthy&#xD;
      hydration, physical activity and additional cross sectional strategies.&#xD;
&#xD;
      The first phase of implementation will be conducted in a total of 58 schools located in&#xD;
      Mexico City purposively selected by the Ministry of Education.&#xD;
&#xD;
      The design evaluation will use available policy documents and program implementation&#xD;
      guidelines, scientific literature, to investigate wether the design of Salud Escolar is&#xD;
      adequate to achieve the proposed objectives.&#xD;
&#xD;
      The implementation evaluation will be conducted in a sub-sample of 6 intervention schools&#xD;
      using qualitative methodologies among key informants.&#xD;
&#xD;
      The results evaluation will be conducted in the 58 intervention schools and pre-post changes&#xD;
      in self-reported knowledge, attitudes and practices related to healthy eating, hydration and&#xD;
      being physically active will be measured.&#xD;
&#xD;
      The impact evaluation aims to evaluate the effect of Salud Escolar on the consumption of&#xD;
      fruits, vegetables and plain water and daily moderate to vigorous physical activity. A sample&#xD;
      of 1200 children (6-12 years old) in 15 intervention schools- randomly selected from the&#xD;
      sample of 58 intervention schools-, and 15 comparison schools - randomly selected from the&#xD;
      waiting list of available schools in the city will be recruited.&#xD;
&#xD;
      Based on the results derived from this analysis, a set of recommendations will be provided to&#xD;
      improve the feasibility of scaling up the program at the national level during the second and&#xD;
      third phases of Salud Escolar.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Schools are in lockdown due to COVID-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">February 17, 2020</start_date>
  <completion_date type="Anticipated">December 16, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 19, 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Masking is not possible because the Ministry of Education specifically announces the implementation of Salud Escolar in each school.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>Accelerometer-based moderate to vigorous intensity physical activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Water consumption</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>School children's water consumption measured using a 24h dietary recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vegetable intake</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>School children's vegetable intake measured using a 24h dietary recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fruit intake</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>School children's fruit intake measured using a 24h dietary recall</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported knowledge</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>A questionnaire based on the theory of planned behavior was used to collect relevant knowledge related to healthy eating, drinking plain water and being physically. There are a total of 8 statements and each statement is rated on a 4 point Likert scale. A knowledge score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported attitudes</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>A questionnaire based on the theory of planned behavior was used to collect relevant attitudes related to healthy eating, drinking plain water and being physically. There are a total of 11 statements and each statement is rated on a 4 point Likert scale. An attitude score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived behavioral control</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>A questionnaire based on the theory of planned behavior is used to collect perceived behavioral control (i.e., self-efficacy) related to healthy eating, drinking plain water and being physically. There are a total of 9 statements and each statement is rated on a 4 point Likert scale. A perceived behavioral control score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported physical activity</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>The physical activity question of the Health Behaviour in School-aged Children questionnaire is used to rate the proportion of children engaging in at least 60 minutes of moderate to vigorous physical activity per day. Assessed at baseline and 10 months later to estimate change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported fruit and vegetable intake</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>A questionnaire based on the theory of planned behavior is used to collect practices related to fruit and vegetable intake. There are a total of 3 statements and each statement is rated on a 4 point Likert scale. A fruit and vegetable intake score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported junk food intake</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>A questionnaire based on the theory of planned behavior is used to collect practices related to junk food consumption (i.e., sweets, candies, pastries, and sugar sweetened beverages). There are a total of 3 statements and each statement is rated on a 4 point Likert scale. A junk food intake score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported water consumption</measure>
    <time_frame>Change from baseline to 10 months</time_frame>
    <description>A questionnaire based on the theory of planned behavior is used to collect practices related to water consumption. There are a total of 2 statements and each statement is rated on a 4 point Likert scale. A water intake score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Lifestyle and environment intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Schools will receive the components of Salud Escolar</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait-list control of schools without intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>World Health Organization Health Promoting Schools</intervention_name>
    <description>Healthy eating: regulation and monitoring of food sold in school cafeterias, healthy eating behavior change campaign, provision of healthy breakfasts.&#xD;
Physical activity: hourly active breaks during classes, quality physical education, active recess, and extra-curricular leisure activities and tournaments.&#xD;
Healthy hydration: access to water fountains and regular monitoring of water safety, regulation and monitoring of beverages sold in the school, and social marketing campaign promoting drinking plain water.&#xD;
Other cross-sectional activities: Referral of children identified as living with underweight, overweight, or obesity, training for school directors, teachers and parents, establishment of school objectives to become a health promoting school, monitoring progress, and publicly acknowledging school progress in becoming a health promoting school.</description>
    <arm_group_label>Lifestyle and environment intervention</arm_group_label>
    <other_name>Salud Escolar</other_name>
    <other_name>Whole-of-school approach to healthy lifestyles</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        School&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Public school&#xD;
&#xD;
          -  Minimum of 200 children&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        + None&#xD;
&#xD;
        Children&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 6 to 12 years&#xD;
&#xD;
          -  Grades 1-6&#xD;
&#xD;
          -  Attending school on the day of recruitment at the included schools in Mexico City,&#xD;
             Mexico during the school-year 2020/2021&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        + Schoolchildren with a physical or mental disability not able to participate in daily&#xD;
        physical activity or other intervention components or measures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alejandra Jáuregui, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Salud Pública</name>
      <address>
        <city>Mexico City</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Salud Publica, Mexico</investigator_affiliation>
    <investigator_full_name>Alejandra Jáuregui de la Mota</investigator_full_name>
    <investigator_title>Chair of the Department of Physical Activity and Healthy Lifestyles</investigator_title>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>healthy eating</keyword>
  <keyword>hydration</keyword>
  <keyword>school intervention</keyword>
  <keyword>health policy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a Data Access agreement.</ipd_description>
  </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>October 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT04507100/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT04507100/ICF_001.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/NCT04507100
org study id: P86-19
nct id: NCT04507100
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to comprehensively evaluate Salud Escolar (School Health), a
      program led by the Mexican Ministries of Health and Education. This comprehensive evaluation
      considers a design, implementation, results, and impact evaluation of Salud Escolar.
This study aims is to comprehensively analyze the design, implementation, results, and impact
      of Salud Escolar, a program led by the Mexican Ministries of Health and Education, during the
      first phase of implementation, from August 2020 to July 2021. Salud Escolar considers the
      World Health Organization (WHO) health promoting framework to foster a healthy environment
      and enhance children's physical activity, healthy eating and hydration. Salud Escolar
      consists on several activities aligned in the following components: healthy eating, healthy
      hydration, physical activity and additional cross sectional strategies.

      The first phase of implementation will be conducted in a total of 58 schools located in
      Mexico City purposively selected by the Ministry of Education.

      The design evaluation will use available policy documents and program implementation
      guidelines, scientific literature, to investigate wether the design of Salud Escolar is
      adequate to achieve the proposed objectives.

      The implementation evaluation will be conducted in a sub-sample of 6 intervention schools
      using qualitative methodologies among key informants.

      The results evaluation will be conducted in the 58 intervention schools and pre-post changes
      in self-reported knowledge, attitudes and practices related to healthy eating, hydration and
      being physically active will be measured.

      The impact evaluation aims to evaluate the effect of Salud Escolar on the consumption of
      fruits, vegetables and plain water and daily moderate to vigorous physical activity. A sample
      of 1200 children (6-12 years old) in 15 intervention schools- randomly selected from the
      sample of 58 intervention schools-, and 15 comparison schools - randomly selected from the
      waiting list of available schools in the city will be recruited.

      Based on the results derived from this analysis, a set of recommendations will be provided to
      improve the feasibility of scaling up the program at the national level during the second and
      third phases of Salud Escolar.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: Masking is not possible because the Ministry of Education specifically announces the implementation of Salud Escolar in each school.
measure: Physical activity
time frame: Change from baseline to 10 months
description: Accelerometer-based moderate to vigorous intensity physical activity
measure: Water consumption
time frame: Change from baseline to 10 months
description: School children's water consumption measured using a 24h dietary recall
measure: Vegetable intake
time frame: Change from baseline to 10 months
description: School children's vegetable intake measured using a 24h dietary recall
measure: Fruit intake
time frame: Change from baseline to 10 months
description: School children's fruit intake measured using a 24h dietary recall
measure: Self-reported knowledge
time frame: Change from baseline to 10 months
description: A questionnaire based on the theory of planned behavior was used to collect relevant knowledge related to healthy eating, drinking plain water and being physically. There are a total of 8 statements and each statement is rated on a 4 point Likert scale. A knowledge score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.
measure: Self-reported attitudes
time frame: Change from baseline to 10 months
description: A questionnaire based on the theory of planned behavior was used to collect relevant attitudes related to healthy eating, drinking plain water and being physically. There are a total of 11 statements and each statement is rated on a 4 point Likert scale. An attitude score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.
measure: Perceived behavioral control
time frame: Change from baseline to 10 months
description: A questionnaire based on the theory of planned behavior is used to collect perceived behavioral control (i.e., self-efficacy) related to healthy eating, drinking plain water and being physically. There are a total of 9 statements and each statement is rated on a 4 point Likert scale. A perceived behavioral control score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.
measure: Self-reported physical activity
time frame: Change from baseline to 10 months
description: The physical activity question of the Health Behaviour in School-aged Children questionnaire is used to rate the proportion of children engaging in at least 60 minutes of moderate to vigorous physical activity per day. Assessed at baseline and 10 months later to estimate change.
measure: Self-reported fruit and vegetable intake
time frame: Change from baseline to 10 months
description: A questionnaire based on the theory of planned behavior is used to collect practices related to fruit and vegetable intake. There are a total of 3 statements and each statement is rated on a 4 point Likert scale. A fruit and vegetable intake score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.
measure: Self-reported junk food intake
time frame: Change from baseline to 10 months
description: A questionnaire based on the theory of planned behavior is used to collect practices related to junk food consumption (i.e., sweets, candies, pastries, and sugar sweetened beverages). There are a total of 3 statements and each statement is rated on a 4 point Likert scale. A junk food intake score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.
measure: Self-reported water consumption
time frame: Change from baseline to 10 months
description: A questionnaire based on the theory of planned behavior is used to collect practices related to water consumption. There are a total of 2 statements and each statement is rated on a 4 point Likert scale. A water intake score is calculated by estimating the mean score of the responses. Assessed at baseline and 10 months later to estimate change.
arm group label: Lifestyle and environment intervention
arm group type: Experimental
description: Schools will receive the components of Salud Escolar
arm group label: Wait-list control
arm group type: No Intervention
description: Wait-list control of schools without intervention.
intervention type: Behavioral
intervention name: World Health Organization Health Promoting Schools
description: Healthy eating: regulation and monitoring of food sold in school cafeterias, healthy eating behavior change campaign, provision of healthy breakfasts.
Physical activity: hourly active breaks during classes, quality physical education, active recess, and extra-curricular leisure activities and tournaments.
Healthy hydration: access to water fountains and regular monitoring of water safety, regulation and monitoring of beverages sold in the school, and social marketing campaign promoting drinking plain water.
Other cross-sectional activities: Referral of children identified as living with underweight, overweight, or obesity, training for school directors, teachers and parents, establishment of school objectives to become a health promoting school, monitoring progress, and publicly acknowledging school progress in becoming a health promoting school.
arm group label: Lifestyle and environment intervention
other name: Salud Escolar
other name: Whole-of-school approach to healthy lifestyles
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Alejandra Jáuregui, ScD
role: Principal Investigator
affiliation: National Institute of public Health
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Salud Publica, Mexico
investigator full name: Alejandra Jáuregui de la Mota
investigator title: Chair of the Department of Physical Activity and Healthy Lifestyles
sharing ipd: Undecided
ipd description: Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a Data Access agreement.
provided document: 
provided document: 