Protocol summary

Study aim
Study the effects of game based nutritional education on nutritional behavior and knowledge of preschool children in Mashhad city
Design
Quasi Experimental trial with control group, parallel group, without blinding, randomised trial, designed of 344 child followed for one month
Settings and conduct
Chosen kindergarten Medical student and nutritionist will teach the game to children and their trainer. Nutritional knowledge of children will be evaluated by standard questionnaires before and one month after playing the game.
Participants/Inclusion and exclusion criteria
5-6 year old children who has been registered at one of the chosen kindergartens, Being Iranian, Not being immigrant, Children without congenital disease or special diseases such as diabetes, cardiovascular disease, metabolic disease, liver disease, kidney disease, epilepsy and psychiatric disorders, Not being on specific diet
Intervention groups
First we divide Mashhad into 9 districts due to social and economic factors, then choose 2 kindergarten in each district and then we pick 20 children from each kindergarten randomly as control and Intervention groups.
Main outcome variables
Improving nutritional knowledge of children Improving children’s interests in healthy diet Improving children’s interests in learning about nutritional knowledge

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240131060868N1
Registration date: 2024-05-27, 1403/03/07
Registration timing: registered_while_recruiting

Last update: 2024-05-27, 1403/03/07
Update count: 0
Registration date
2024-05-27, 1403/03/07
Registrant information
Name
Reihane Mahmoudy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 4565
Email address
reihan.mahmoudy@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2025-10-23, 1404/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of game-based nutrition education on nutritional knowledge of preschool children
Public title
Effect of game-based nutrition education on nutritional knowledge of preschool children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
5-6 year old children who has been registered at one of the chosen kindergartens Being Iranian Not being immigrant Children without congenital diseases or special diseases such as diabetes, cardiovascular diseases, metabolic disease, liver disease, kidney disease, epilepsy and psychiatric disorders Not being on a specific diet
Exclusion criteria:
Children with congenital diseases or special diseases such as diabetes, cardiovascular diseases, metabolic disease, liver disease, kidney disease, epilepsy and psychiatric disorders Being on a specific diet Refuse to participate in the research Getting sick during the research Losing parent/ parents during the research
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 344
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is useing of Random allocation software. A list of random blocks with variable sizes of 4 and 6, each block containing an equal number of groups, will be designed and a unique number will be given to each block. The arrangement of the contents of each block implies the balanced allocation of people in the studied groups. When each child enters the study, one of the blocks is randomly selected and according to the order of the contents, the child is assigned to one of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad Faculty of Medical Sciences
Street address
Azadi Square, East Gate of Mashhad University of Medical Sciences, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.339

Health conditions studied

1

Description of health condition studied
Nutrition knowledge
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nutritional knowledge of preschool children
Timepoint
Before playing the game and one month after playing the game
Method of measurement
Standardization of Children's Eating Behavior Questionnaire (CEBQ)

Secondary outcomes

1

Description
Evaluation of nutritional knowledge in children after playing the game called “Taas e khoshmaze” for one month
Timepoint
Before playing the game and one month after playing the game
Method of measurement
CEBQ questionnaire

Intervention groups

1

Description
Intervention group: playing the game called "Taas e khoshmazze" means "Tasty Dice". At the beginning of the study and one month after the intervention, children's nutrition knowledge is measured using a questionnaire including 9 questions and answers. (This questionnaire is valid and reliable and has been used in the Iranian population so far. This questionnaire is the result of an article that was conducted in Shiraz.)The interviewers read the questions and ask the children to choose the correct answer from the pictures.You can see the questionnaire questions here: "Which food is good for the heart" Which foods provide enough energy" "What snacks are unhealthy" "Which foods can't help you grow" "Which foods help you grow" "Which Foods Improve Your Health" "Which food strengthens bones" "Which food is bad for the heart" "Which foods are needed every day to improve health" Then their nutritional knowledge is scored from 0 to 9. Also, at the beginning of the study and one month after the intervention, the dietary behavior changes of these children will be evaluated by measuring 35 behavioral components through the CEBQ questionnaire. The game training will be done by a medical student and a partner of the project (Bachelor of Nutrition) and the children of the intervention group will play this game for 30 minutes a day for a month.
Category
N/A

2

Description
Control group: At the beginning of the study and one month after the intervention, children's nutrition knowledge is measured using a questionnaire including 9 questions and answers. (This questionnaire is valid and reliable and has been used in the Iranian population so far. The questionnaire is the result of an article that was conducted in Shiraz.) Also, at the beginning of the study and one month later, the changes in the eating behavior of these children will be evaluated by measuring 35 behavioral components through the CEBQ questionnaire. On the other hand, children in the control group did not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad kindergarten
Full name of responsible person
Reihan Mahmoudy
Street address
No 7, 7th Vakilabaad Ave, Vakilabaad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188887350
Phone
+98 915 697 5365
Email
Reihan.Mahmoudy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
No 7, 7th Vakilabaad Ave, Vakilabaad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188887350
Phone
+98 915 697 5365
Email
Reihan.mahmoudy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reihane Mahmoudy
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Azaadi square, University of medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9188887350
Phone
+98 51 3841 4565
Fax
Email
Reihan.mahmoudy@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reihan Mahmoudy
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 7, 7th Vakilabaad Alley, Valilabaad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188887350
Phone
+98 915 697 5365
Email
Reihan.mahmoudy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reihan Mahmoudy
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 7, 7th Vakilabaad Alley, Valilabaad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188887350
Phone
+98 915 697 5365
Email
Reihan.mahmoudy@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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