Examining the Impact of a Mobile Nutrition Education App for Child Nutrition Education in Canada

August 1, 2025 updated by: JoAnne Arcand, University of Ontario Institute of Technology

Efficacy of a Digital School-Based Nutrition Education Intervention to Improve Children's Healthy Eating Knowledge, Attitudes and Behaviours

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 4/5 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. Thirty-two Grade 4 and 4/5 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
616

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1G0C5
        • University of Ontario Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Grade 4 or 4/5 classroom
  • Classroom is located in a participating school board in Ontario

Exclusion Criteria:

  • Classroom has already covered the "Healthy Eating" component of the Ontario Physical Health Education curriculum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Other: Conventional nutrition education intervention
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.
Experimental: Experimental (Foodbot Factory) Group
Other: Serious game nutrition education intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall nutrition knowledge
Time Frame: Measured at baseline and immediately post-intervention (Day 5).
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.
Measured at baseline and immediately post-intervention (Day 5).
Overall nutrition knowledge
Time Frame: Measured at baseline and 4 weeks post-intervention.
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.
Measured at baseline and 4 weeks post-intervention.
Overall nutrition knowledge
Time Frame: Measured at baseline and 3 months post-intervention.
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.
Measured at baseline and 3 months post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Drinks knowledge
Time Frame: Measured at baseline and immediately post-intervention (Day 5).
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.
Measured at baseline and immediately post-intervention (Day 5).
Drinks knowledge
Time Frame: Measured at baseline and 4 weeks post-intervention.
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.
Measured at baseline and 4 weeks post-intervention.
Drinks knowledge
Time Frame: Measured at baseline and 3 months post-intervention.
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.
Measured at baseline and 3 months post-intervention.
Whole grain foods knowledge
Time Frame: Measured at baseline and immediately post-intervention (Day 5).
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.
Measured at baseline and immediately post-intervention (Day 5).
Whole grain foods knowledge
Time Frame: Measured at baseline and 4 weeks post-intervention.
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.
Measured at baseline and 4 weeks post-intervention.
Whole grain foods knowledge
Time Frame: Measured at baseline and 3 months post-intervention.
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.
Measured at baseline and 3 months post-intervention.
Vegetables & fruit knowledge
Time Frame: Measured at baseline and immediately post-intervention (Day 5).
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.
Measured at baseline and immediately post-intervention (Day 5).
Vegetables & fruit knowledge
Time Frame: Measured at baseline and 4 weeks post-intervention.
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.
Measured at baseline and 4 weeks post-intervention.
Vegetables & fruit knowledge
Time Frame: Measured at baseline and 3 months post-intervention.
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.
Measured at baseline and 3 months post-intervention.
Protein foods knowledge
Time Frame: Measured at baseline and immediately post-intervention (Day 5).
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.
Measured at baseline and immediately post-intervention (Day 5).
Protein foods knowledge
Time Frame: Measured at baseline and 4 weeks post-intervention.
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.
Measured at baseline and 4 weeks post-intervention.
Protein foods knowledge
Time Frame: Measured at baseline and 3 months post-intervention.
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.
Measured at baseline and 3 months post-intervention.
Nutrition attitudes
Time Frame: Measured at baseline and immediately post-intervention (Day 5).
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.
Measured at baseline and immediately post-intervention (Day 5).
Nutrition attitudes
Time Frame: Measured at baseline and 4 weeks post-intervention.
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.
Measured at baseline and 4 weeks post-intervention.
Nutrition attitudes
Time Frame: Measured at baseline and 3 months post-intervention.
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.
Measured at baseline and 3 months post-intervention.
Dietary intake
Time Frame: Measured at baseline and immediately post-intervention (Day 5).
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.
Measured at baseline and immediately post-intervention (Day 5).
Dietary intake
Time Frame: Measured at baseline and 4 weeks post-intervention.
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.
Measured at baseline and 4 weeks post-intervention.
Dietary intake
Time Frame: Measured at baseline and 3 months post-intervention.
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.
Measured at baseline and 3 months post-intervention.
General nutrition behaviours
Time Frame: Measured at baseline and immediately post-intervention (Day 5).
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.
Measured at baseline and immediately post-intervention (Day 5).
General nutrition behaviours
Time Frame: Measured at baseline and 4 weeks post-intervention.
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.
Measured at baseline and 4 weeks post-intervention.
General nutrition behaviours
Time Frame: Measured at baseline and 3 months post-intervention.
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.
Measured at baseline and 3 months post-intervention.
Intervention acceptability
Time Frame: Measured immediately post-intervention (Day 5).
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.
Measured immediately post-intervention (Day 5).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ontario Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JoAnne Arcand, PhD, RD, University of Ontario Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17109 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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 Sharing 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 Sharing Access Criteria

Data will be made available to researchers upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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