xml: <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/NCT05979259</url>
    </required_header>
    <id_info>
      <org_study_id>17109</org_study_id>
      <nct_id>NCT05979259</nct_id>
    </id_info>
    <brief_title>Examining the Impact of a Mobile Nutrition Education App for Child Nutrition Education in Canada</brief_title>
    <official_title>Efficacy of a Digital School-Based Nutrition Education Intervention to Improve Children's Healthy Eating Knowledge, Attitudes and Behaviours</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Ontario Institute of Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Ontario Institute of Technology</source>
    <oversight_info>
      <has_dmc>No</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>
        This trial will test the hypothesis that a digital curriculum-based nutrition education&#xD;
        intervention using the Foodbot Factory serious game (i.e., a game designed for learning)&#xD;
        leads to greater student engagement and learning about nutrition, compared to conventional&#xD;
        nutrition education (e.g., worksheets), among students in Grades 4 and 5 in Ontario, Canada.&#xD;
        This hypothesis is based on existing research suggesting that digital serious games, when&#xD;
        well-integrated into the classroom setting, promote greater student engagement, learning and&#xD;
        knowledge retention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This two-arm parallel cluster randomized controlled efficacy trial will determine if a&#xD;
        digital curriculum-based nutrition education intervention (intervention group) leads to&#xD;
        greater increases in overall nutrition knowledge compared to conventional nutrition education&#xD;
        (control group) in Grade 4 and 5 classrooms after 1 week, and that it facilitates greater&#xD;
        retention at 4 weeks and 3 months following the intervention period. Secondary outcomes&#xD;
        include sub-scores of nutrition knowledge (i.e., knowledge of specific food groupings),&#xD;
        nutrition attitudes, general child nutrition behaviours and dietary intakes. Due to the&#xD;
        enhanced engagement serious games can provide, it is hypothesized that participants in the&#xD;
        intervention group will show greater changes in and retention of their nutrition knowledge&#xD;
        and nutrition behaviours. Twenty-eight Grade 4, 4/5 and 5 classrooms in Ontario, Canada will&#xD;
        be randomized to the intervention or control group. Participants in both groups will receive&#xD;
        nutrition education lessons for 35-40 minutes a day for five consecutive days. Participants&#xD;
        in the intervention group will use the Foodbot Factory serious game while participants in the&#xD;
        control group will use conventional learning materials (e.g., worksheets, teacher-led&#xD;
        instruction). Both interventions will have these learning materials integrated into&#xD;
        standardized nutrition education lesson plans. Overall and sub-scores of nutrition knowledge,&#xD;
        and nutrition attitudes will be assessed using the Nutrition Attitudes and Knowledge&#xD;
        questionnaire. General child nutrition behaviours (e.g., frequency of eating meals outside&#xD;
        the home) will be assessed using a modified version of the Family Nutrition and Physical&#xD;
        Activity Screening Tool and dietary intake will be assessed using the Block Food Screener for&#xD;
        Ages 2-17. At baseline, parents and classroom teachers will respectively complete demographic&#xD;
        questionnaires to measure co-variates that may impact outcomes of interest (e.g., household&#xD;
        food security, presence of school food programs).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Overall nutrition knowledge</measure>
      <time_frame>Measured at baseline and immediately post-intervention (Day 5).</time_frame>
      <description>Change in knowledge of healthy food choices based on Canada's Food Guide from baseline to immediately post-intervention as assessed by the Nutrition Attitudes and Knowledge Questionnaire. The minimum score is 0 and the maximum score is 20 with higher scores indicating higher knowledge.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall nutrition knowledge</measure>
      <time_frame>Measured at baseline and 4 weeks post-intervention.</time_frame>
      <description>Change in knowledge of healthy food choices based on Canada's Food Guide from baseline to immediately post-intervention as assessed by the Nutrition Attitudes and Knowledge Questionnaire. The minimum score is 0 and the maximum score is 20 with higher scores indicating higher knowledge.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall nutrition knowledge</measure>
      <time_frame>Measured at baseline and 3 months post-intervention.</time_frame>
      <description>Change in knowledge of healthy food choices based on Canada's Food Guide from baseline to immediately post-intervention as assessed by the Nutrition Attitudes and Knowledge Questionnaire. The minimum score is 0 and the maximum score is 20 with higher scores indicating higher knowledge.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Drinks knowledge</measure>
      <time_frame>Measured at baseline and immediately post-intervention (Day 5).</time_frame>
      <description>Change in knowledge of drink choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drinks knowledge</measure>
      <time_frame>Measured at baseline and 4 weeks post-intervention.</time_frame>
      <description>Change in knowledge of drink choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drinks knowledge</measure>
      <time_frame>Measured at baseline and 3 months post-intervention.</time_frame>
      <description>Change in knowledge of drink choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Whole grain foods knowledge</measure>
      <time_frame>Measured at baseline and immediately post-intervention (Day 5).</time_frame>
      <description>Change in knowledge of whole grain food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Whole grain foods knowledge</measure>
      <time_frame>Measured at baseline and 4 weeks post-intervention.</time_frame>
      <description>Change in knowledge of whole grain food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Whole grain foods knowledge</measure>
      <time_frame>Measured at baseline and 3 months post-intervention.</time_frame>
      <description>Change in knowledge of whole grain food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vegetables &amp; fruit knowledge</measure>
      <time_frame>Measured at baseline and immediately post-intervention (Day 5).</time_frame>
      <description>Change in knowledge of vegetable &amp; fruit choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vegetables &amp; fruit knowledge</measure>
      <time_frame>Measured at baseline and 4 weeks post-intervention.</time_frame>
      <description>Change in knowledge of vegetable &amp; fruit choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vegetables &amp; fruit knowledge</measure>
      <time_frame>Measured at baseline and 3 months post-intervention.</time_frame>
      <description>Change in knowledge of vegetable &amp; fruit choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The maximum score on the scale is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Protein foods knowledge</measure>
      <time_frame>Measured at baseline and immediately post-intervention (Day 5).</time_frame>
      <description>Change in knowledge of protein food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Protein foods knowledge</measure>
      <time_frame>Measured at baseline and 4 weeks post-intervention.</time_frame>
      <description>Change in knowledge of protein choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Protein foods knowledge</measure>
      <time_frame>Measured at baseline and 3 months post-intervention.</time_frame>
      <description>Change in knowledge of protein food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutrition attitudes</measure>
      <time_frame>Measured at baseline and immediately post-intervention (Day 5).</time_frame>
      <description>Change in attitudes towards nutrition and healthy eating assessed by the Nutrition Attitudes and Knowledge Questionnaire. Minimum score is 4 and maximum score is 20 with higher scores indicating more positive attitudes towards nutrition and healthy eating.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutrition attitudes</measure>
      <time_frame>Measured at baseline and 4 weeks post-intervention.</time_frame>
      <description>Change in attitudes towards nutrition and healthy eating assessed by the Nutrition Attitudes and Knowledge Questionnaire. Minimum score is 4 and maximum score is 20 with higher scores indicating more positive attitudes towards nutrition and healthy eating.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutrition attitudes</measure>
      <time_frame>Measured at baseline and 3 months post-intervention.</time_frame>
      <description>Change in attitudes towards nutrition and healthy eating assessed by the Nutrition Attitudes and Knowledge Questionnaire. Minimum score is 4 and maximum score is 20 with higher scores indicating more positive attitudes towards nutrition and healthy eating.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>Measured at baseline and immediately post-intervention (Day 5).</time_frame>
      <description>Change in usual intake of foods (e.g., fruit, vegetables, whole grains), reported as average number of daily servings, over the past week assessed by the Block Food Screener Kids.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>Measured at baseline and 4 weeks post-intervention.</time_frame>
      <description>Change in usual intake of foods (e.g., fruit, vegetables, whole grains), reported as average number of daily servings, over the past week assessed by the Block Food Screener Kids.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>Measured at baseline and 3 months post-intervention.</time_frame>
      <description>Change in usual intake of foods (e.g., fruit, vegetables, whole grains), reported as average number of daily servings, over the past week assessed by the Block Food Screener Kids.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General nutrition behaviours</measure>
      <time_frame>Measured at baseline and immediately post-intervention (Day 5).</time_frame>
      <description>Change in behaviours relevant to nutrition and eating (e.g., frequency of consuming breakfast and meals outside the home) assessed by a modified version of the Family Nutrition and Physical Activity Screening Tool. There are 10 questions evaluating how often the child engages in a nutrition behaviour, with responses ranging from Never/Almost Never (1) to Very Often/Always (4). Changes in each behaviour will be reported independently.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General nutrition behaviours</measure>
      <time_frame>Measured at baseline and 4 weeks post-intervention.</time_frame>
      <description>Change in behaviours relevant to nutrition and eating (e.g., frequency of consuming breakfast and meals outside the home) assessed by a modified version of the Family Nutrition and Physical Activity Screening Tool. There are 10 questions evaluating how often the child engages in a nutrition behaviour, with responses ranging from Never/Almost Never (1) to Very Often/Always (4). Changes in each behaviour will be reported independently.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General nutrition behaviours</measure>
      <time_frame>Measured at baseline and 3 months post-intervention.</time_frame>
      <description>Change in behaviours relevant to nutrition and eating (e.g., frequency of consuming breakfast and meals outside the home) assessed by a modified version of the Family Nutrition and Physical Activity Screening Tool. There are 10 questions evaluating how often the child engages in a nutrition behaviour, with responses ranging from Never/Almost Never (1) to Very Often/Always (4). Changes in each behaviour will be reported independently.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention acceptability</measure>
      <time_frame>Measured immediately post-intervention (Day 5).</time_frame>
      <description>Acceptability of the nutrition education interventions assessed by a questionnaire based on the Theoretical Framework of Acceptability. There are 11 questions evaluating different dimensions of intervention acceptability, with responses ranging from 1, indicating strong disagreement, to 5, indicating strong agreement (response options are specific to each question). Responses to each question will be reported independently.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">672</enrollment>
    <condition>Nutrition, Healthy</condition>
    <arm_group>
      <arm_group_label>Experimental (Foodbot Factory) Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Serious game nutrition education intervention</intervention_name>
      <description>Classrooms will receive nutrition education lessons for 35-40 minutes for 5 consecutive days. As part of each lesson, students will play the &quot;Foodbot Factory&quot; nutrition education serious game for 10-15 minutes. The Foodbot Factory serious game and lessons are based on Ontario curriculum requirements and aligned Canada's Food Guide.</description>
      <arm_group_label>Experimental (Foodbot Factory) Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional nutrition education intervention</intervention_name>
      <description>Classrooms will receive nutrition education lessons for 35-40 minutes for 5 consecutive days. As part of each lesson, students will use conventional learning activities, such as worksheets, sourced from an online teaching resource repository. The lessons are based on Ontario curriculum requirements and aligned Canada's Food Guide.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Grade 4, 4/5 or 5 classroom&#xD;
  &#xD;
            -  Classroom is located in a participating school board in Ontario&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Classroom has already covered the &quot;Healthy Eating&quot; component of the Ontario Physical&#xD;
               Health Education curriculum&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>JoAnne Arcand, PhD, RD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Ontario Institute of Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>JoAnne Arcand, PhD, RD</last_name>
      <phone>647-296-8426</phone>
      <email>joanne.arcand@ontariotechu.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jacqueline Brown, MHSc</last_name>
      <phone>905-441-1376</phone>
      <email>jacqueline.brown@ontariotechu.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Ontario Institute of Technology</name>
        <address>
          <city>Oshawa</city>
          <state>Ontario</state>
          <zip>L1G0C5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>JoAnne Arcand, PhD, RD</last_name>
        <phone>647-296-8426</phone>
        <email>joanne.arcand@ontariotechu.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Brown JM, Savaglio R, Watson G, Kaplansky A, LeSage A, Hughes J, Kapralos B, Arcand J. Optimizing Child Nutrition Education With the Foodbot Factory Mobile Health App: Formative Evaluation and Analysis. JMIR Form Res. 2020 Apr 17;4(4):e15534. doi: 10.2196/15534.</citation>
      <PMID>32301743</PMID>
    </reference>
    <reference>
      <citation>Froome HM, Townson C, Rhodes S, Franco-Arellano B, LeSage A, Savaglio R, Brown JM, Hughes J, Kapralos B, Arcand J. The Effectiveness of the Foodbot Factory Mobile Serious Game on Increasing Nutrition Knowledge in Children. Nutrients. 2020 Nov 6;12(11):3413. doi: 10.3390/nu12113413.</citation>
      <PMID>33172094</PMID>
    </reference>
    <reference>
      <citation>Franco-Arellano B, Brown JM, Froome HM, LeSage A, Arcand J. Development and pilot testing of the Nutrition Attitudes and Knowledge Questionnaire to measure changes of child nutrition knowledge related to the Canada's Food Guide. Appl Physiol Nutr Metab. 2021 Dec;46(12):1495-1501. doi: 10.1139/apnm-2021-0170. Epub 2021 Jul 21.</citation>
      <PMID>34289315</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Ontario Institute of Technology</investigator_affiliation>
      <investigator_full_name>JoAnne Arcand</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Diet, Healthy</keyword>
    <keyword>Digital Technology</keyword>
    <keyword>Gamification</keyword>
    <keyword>Health Education</keyword>
    <keyword>School Health Services</keyword>
    <keyword>Food Literacy</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The research team aims to publish the study findings in a peer-reviewed journal and at academic conferences. The investigators will make an anonymized copy of the data available in an online repository.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>When the study is complete, determined by the date on which the findings are published, electronic files will be stored for 5 years per guidelines from the Canadian Institutes of Health Research. Data can be made available following study completion, up until its disposal.</ipd_time_frame>
      <ipd_access_criteria>Data will be made available to researchers upon reasonable request.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979259
  org study id: 17109
  nct id: NCT05979259
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This trial will test the hypothesis that a digital curriculum-based nutrition education
        intervention using the Foodbot Factory serious game (i.e., a game designed for learning)
        leads to greater student engagement and learning about nutrition, compared to conventional
        nutrition education (e.g., worksheets), among students in Grades 4 and 5 in Ontario, Canada.
        This hypothesis is based on existing research suggesting that digital serious games, when
        well-integrated into the classroom setting, promote greater student engagement, learning and
        knowledge retention.
  This two-arm parallel cluster randomized controlled efficacy trial will determine if a
        digital curriculum-based nutrition education intervention (intervention group) leads to
        greater increases in overall nutrition knowledge compared to conventional nutrition education
        (control group) in Grade 4 and 5 classrooms after 1 week, and that it facilitates greater
        retention at 4 weeks and 3 months following the intervention period. Secondary outcomes
        include sub-scores of nutrition knowledge (i.e., knowledge of specific food groupings),
        nutrition attitudes, general child nutrition behaviours and dietary intakes. Due to the
        enhanced engagement serious games can provide, it is hypothesized that participants in the
        intervention group will show greater changes in and retention of their nutrition knowledge
        and nutrition behaviours. Twenty-eight Grade 4, 4/5 and 5 classrooms in Ontario, Canada will
        be randomized to the intervention or control group. Participants in both groups will receive
        nutrition education lessons for 35-40 minutes a day for five consecutive days. Participants
        in the intervention group will use the Foodbot Factory serious game while participants in the
        control group will use conventional learning materials (e.g., worksheets, teacher-led
        instruction). Both interventions will have these learning materials integrated into
        standardized nutrition education lesson plans. Overall and sub-scores of nutrition knowledge,
        and nutrition attitudes will be assessed using the Nutrition Attitudes and Knowledge
        questionnaire. General child nutrition behaviours (e.g., frequency of eating meals outside
        the home) will be assessed using a modified version of the Family Nutrition and Physical
        Activity Screening Tool and dietary intake will be assessed using the Block Food Screener for
        Ages 2-17. At baseline, parents and classroom teachers will respectively complete demographic
        questionnaires to measure co-variates that may impact outcomes of interest (e.g., household
        food security, presence of school food programs).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Overall nutrition knowledge
  time frame: Measured at baseline and immediately post-intervention (Day 5).
  description: Change in knowledge of healthy food choices based on Canada's Food Guide from baseline to immediately post-intervention as assessed by the Nutrition Attitudes and Knowledge Questionnaire. The minimum score is 0 and the maximum score is 20 with higher scores indicating higher knowledge.
  measure: Overall nutrition knowledge
  time frame: Measured at baseline and 4 weeks post-intervention.
  description: Change in knowledge of healthy food choices based on Canada's Food Guide from baseline to immediately post-intervention as assessed by the Nutrition Attitudes and Knowledge Questionnaire. The minimum score is 0 and the maximum score is 20 with higher scores indicating higher knowledge.
  measure: Overall nutrition knowledge
  time frame: Measured at baseline and 3 months post-intervention.
  description: Change in knowledge of healthy food choices based on Canada's Food Guide from baseline to immediately post-intervention as assessed by the Nutrition Attitudes and Knowledge Questionnaire. The minimum score is 0 and the maximum score is 20 with higher scores indicating higher knowledge.
  measure: Drinks knowledge
  time frame: Measured at baseline and immediately post-intervention (Day 5).
  description: Change in knowledge of drink choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Drinks knowledge
  time frame: Measured at baseline and 4 weeks post-intervention.
  description: Change in knowledge of drink choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Drinks knowledge
  time frame: Measured at baseline and 3 months post-intervention.
  description: Change in knowledge of drink choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Whole grain foods knowledge
  time frame: Measured at baseline and immediately post-intervention (Day 5).
  description: Change in knowledge of whole grain food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Whole grain foods knowledge
  time frame: Measured at baseline and 4 weeks post-intervention.
  description: Change in knowledge of whole grain food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Whole grain foods knowledge
  time frame: Measured at baseline and 3 months post-intervention.
  description: Change in knowledge of whole grain food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Vegetables & fruit knowledge
  time frame: Measured at baseline and immediately post-intervention (Day 5).
  description: Change in knowledge of vegetable & fruit choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Vegetables & fruit knowledge
  time frame: Measured at baseline and 4 weeks post-intervention.
  description: Change in knowledge of vegetable & fruit choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Vegetables & fruit knowledge
  time frame: Measured at baseline and 3 months post-intervention.
  description: Change in knowledge of vegetable & fruit choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The maximum score on the scale is 5 with higher scores indicating higher knowledge.
  measure: Protein foods knowledge
  time frame: Measured at baseline and immediately post-intervention (Day 5).
  description: Change in knowledge of protein food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Protein foods knowledge
  time frame: Measured at baseline and 4 weeks post-intervention.
  description: Change in knowledge of protein choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Protein foods knowledge
  time frame: Measured at baseline and 3 months post-intervention.
  description: Change in knowledge of protein food choices based on Canada's Food Guide and assessed by the Nutrition Knowledge and Attitudes Questionnaire. The minimum score is 0 and the maximum score is 5 with higher scores indicating higher knowledge.
  measure: Nutrition attitudes
  time frame: Measured at baseline and immediately post-intervention (Day 5).
  description: Change in attitudes towards nutrition and healthy eating assessed by the Nutrition Attitudes and Knowledge Questionnaire. Minimum score is 4 and maximum score is 20 with higher scores indicating more positive attitudes towards nutrition and healthy eating.
  measure: Nutrition attitudes
  time frame: Measured at baseline and 4 weeks post-intervention.
  description: Change in attitudes towards nutrition and healthy eating assessed by the Nutrition Attitudes and Knowledge Questionnaire. Minimum score is 4 and maximum score is 20 with higher scores indicating more positive attitudes towards nutrition and healthy eating.
  measure: Nutrition attitudes
  time frame: Measured at baseline and 3 months post-intervention.
  description: Change in attitudes towards nutrition and healthy eating assessed by the Nutrition Attitudes and Knowledge Questionnaire. Minimum score is 4 and maximum score is 20 with higher scores indicating more positive attitudes towards nutrition and healthy eating.
  measure: Dietary intake
  time frame: Measured at baseline and immediately post-intervention (Day 5).
  description: Change in usual intake of foods (e.g., fruit, vegetables, whole grains), reported as average number of daily servings, over the past week assessed by the Block Food Screener Kids.
  measure: Dietary intake
  time frame: Measured at baseline and 4 weeks post-intervention.
  description: Change in usual intake of foods (e.g., fruit, vegetables, whole grains), reported as average number of daily servings, over the past week assessed by the Block Food Screener Kids.
  measure: Dietary intake
  time frame: Measured at baseline and 3 months post-intervention.
  description: Change in usual intake of foods (e.g., fruit, vegetables, whole grains), reported as average number of daily servings, over the past week assessed by the Block Food Screener Kids.
  measure: General nutrition behaviours
  time frame: Measured at baseline and immediately post-intervention (Day 5).
  description: Change in behaviours relevant to nutrition and eating (e.g., frequency of consuming breakfast and meals outside the home) assessed by a modified version of the Family Nutrition and Physical Activity Screening Tool. There are 10 questions evaluating how often the child engages in a nutrition behaviour, with responses ranging from Never/Almost Never (1) to Very Often/Always (4). Changes in each behaviour will be reported independently.
  measure: General nutrition behaviours
  time frame: Measured at baseline and 4 weeks post-intervention.
  description: Change in behaviours relevant to nutrition and eating (e.g., frequency of consuming breakfast and meals outside the home) assessed by a modified version of the Family Nutrition and Physical Activity Screening Tool. There are 10 questions evaluating how often the child engages in a nutrition behaviour, with responses ranging from Never/Almost Never (1) to Very Often/Always (4). Changes in each behaviour will be reported independently.
  measure: General nutrition behaviours
  time frame: Measured at baseline and 3 months post-intervention.
  description: Change in behaviours relevant to nutrition and eating (e.g., frequency of consuming breakfast and meals outside the home) assessed by a modified version of the Family Nutrition and Physical Activity Screening Tool. There are 10 questions evaluating how often the child engages in a nutrition behaviour, with responses ranging from Never/Almost Never (1) to Very Often/Always (4). Changes in each behaviour will be reported independently.
  measure: Intervention acceptability
  time frame: Measured immediately post-intervention (Day 5).
  description: Acceptability of the nutrition education interventions assessed by a questionnaire based on the Theoretical Framework of Acceptability. There are 11 questions evaluating different dimensions of intervention acceptability, with responses ranging from 1, indicating strong disagreement, to 5, indicating strong agreement (response options are specific to each question). Responses to each question will be reported independently.
  arm group label: Experimental (Foodbot Factory) Group
  arm group type: Experimental
  arm group label: Control Group
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Serious game nutrition education intervention
  description: Classrooms will receive nutrition education lessons for 35-40 minutes for 5 consecutive days. As part of each lesson, students will play the "Foodbot Factory" nutrition education serious game for 10-15 minutes. The Foodbot Factory serious game and lessons are based on Ontario curriculum requirements and aligned Canada's Food Guide.
  arm group label: Experimental (Foodbot Factory) Group
  intervention type: Other
  intervention name: Conventional nutrition education intervention
  description: Classrooms will receive nutrition education lessons for 35-40 minutes for 5 consecutive days. As part of each lesson, students will use conventional learning activities, such as worksheets, sourced from an online teaching resource repository. The lessons are based on Ontario curriculum requirements and aligned Canada's Food Guide.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: JoAnne Arcand, PhD, RD
  role: Principal Investigator
  affiliation: University of Ontario Institute of Technology
  last name: JoAnne Arcand, PhD, RD
  phone: 647-296-8426
  email: joanne.arcand@ontariotechu.ca
  last name: Jacqueline Brown, MHSc
  phone: 905-441-1376
  email: jacqueline.brown@ontariotechu.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  citation: Brown JM, Savaglio R, Watson G, Kaplansky A, LeSage A, Hughes J, Kapralos B, Arcand J. Optimizing Child Nutrition Education With the Foodbot Factory Mobile Health App: Formative Evaluation and Analysis. JMIR Form Res. 2020 Apr 17;4(4):e15534. doi: 10.2196/15534.
  PMID: 32301743
  citation: Froome HM, Townson C, Rhodes S, Franco-Arellano B, LeSage A, Savaglio R, Brown JM, Hughes J, Kapralos B, Arcand J. The Effectiveness of the Foodbot Factory Mobile Serious Game on Increasing Nutrition Knowledge in Children. Nutrients. 2020 Nov 6;12(11):3413. doi: 10.3390/nu12113413.
  PMID: 33172094
  citation: Franco-Arellano B, Brown JM, Froome HM, LeSage A, Arcand J. Development and pilot testing of the Nutrition Attitudes and Knowledge Questionnaire to measure changes of child nutrition knowledge related to the Canada's Food Guide. Appl Physiol Nutr Metab. 2021 Dec;46(12):1495-1501. doi: 10.1139/apnm-2021-0170. Epub 2021 Jul 21.
  PMID: 34289315
  responsible party type: Principal Investigator
  investigator affiliation: University of Ontario Institute of Technology
  investigator full name: JoAnne Arcand
  investigator title: Associate Professor
  sharing ipd: Yes
  ipd description: The research team aims to publish the study findings in a peer-reviewed journal and at academic conferences. The investigators will make an anonymized copy of the data available in an online repository.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: When the study is complete, determined by the date on which the findings are published, electronic files will be stored for 5 years per guidelines from the Canadian Institutes of Health Research. Data can be made available following study completion, up until its disposal.
  ipd access criteria: Data will be made available to researchers upon reasonable request.