- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05979259
Examining the Impact of a Mobile Nutrition Education App for Child Nutrition Education in Canada
August 4, 2023 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
Recruiting
Conditions
Intervention / Treatment
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 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).
Study Type
Interventional
Enrollment (Estimated)
672
Phase
- 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
- Name: JoAnne Arcand, PhD, RD
- Phone Number: 647-296-8426
- Email: joanne.arcand@ontariotechu.ca
Study Contact Backup
- Name: Jacqueline Brown, MHSc
- Phone Number: 905-441-1376
- Email: jacqueline.brown@ontariotechu.ca
Study Locations
-
-
Ontario
-
Oshawa, Ontario, Canada, L1G0C5
- Recruiting
- University of Ontario Institute of Technology
-
Contact:
- JoAnne Arcand, PhD, RD
- Phone Number: 647-296-8426
- Email: joanne.arcand@ontariotechu.ca
-
-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Grade 4, 4/5 or 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 |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
|
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
|
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
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
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.
Collaborators
Investigators
- 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
- 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.
- 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.
- 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.
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 (Estimated)
September 18, 2023
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
July 13, 2023
First Submitted That Met QC Criteria
August 4, 2023
First Posted (Actual)
August 7, 2023
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17109
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
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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