Study the effect of nutrition education via mobile-based game,on nutritional knowledge, dietary habits, dietary diversity and growth indices in 5-6 years old children
Determination of the educational effect of mobile-based nutrition education game on nutritional knowledge, dietary habits, dietary diversity and growth indices in 5-6 years old children
Design
Clinical trial with two groups of intervention and control in 5-6 years old-parallel, no blinded and randomized groups-Based on e-learning
Settings and conduct
Preschools in 4 educational areas of Shiraz, selected and divided into intervention and control groups randomly and eligible volunteers will be included in the study.
Participants/Inclusion and exclusion criteria
5-6 years old children, Shiraz resident, healthy and without any chronic, mental, motor or mental illnesses, healthy parents with literacy, access to Android mobile phone
Intervention groups
Intervention group: 5-6 years old children who play electronic games on their mobile phone or tablet one hour a day.
Control group: 5-6 year old children who do not receive any nutritional education from the researcher during the intervention period.
Main outcome variables
Anthropometric measurement
Determination dietary diversity score
Determination dietary habits
Determination of nutritional awareness of children and parents
Comparison of changes of these variables in preschool children of control group with intervention group at the end of the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190810044496N1
Registration date:2019-08-26, 1398/06/04
Registration timing:prospective
Last update:2019-08-26, 1398/06/04
Update count:1
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Maryam al sadat Riasatian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9629
Email address
maryam_riasatian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of nutrition education via mobile-based game,on nutritional knowledge, dietary habits, dietary diversity and growth indices in 5-6 years old children
Public title
Study the effect of nutrition education via mobile-based game,on nutritional knowledge, dietary habits, dietary diversity and growth indices in 5-6 years old children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
5 to 6 year old children
Shiraz resident
Healthy and without any chronic and mental , motor and psychologicall disease
Healthy parents with literacy
Access to android mobile phone
Willing to cooperate during the study period
Obtaining written consent
Exclusion criteria:
Existence of any congenital, chronic diseases , motor and mental disorders
Cancer
Malignant diseases (kidney and liver disease, severe anemia, heart disease, pulmonary failure, type 1 and type 2 diabetes, neurological diseases, mental illness and behavioral disorders such as autism and attention deficit disorder and gastrointestinal inflammatory diseases
Any disease with a specific diet therapy
Age
From 5 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster randomization based on 4 educational areas of Shiraz
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present study is the first study to teach nutrition as an e-game in this age group (inability to read and write), so the process of design and construction of the game should be step by step based on creativity, taste and charm,and the details designed for the original framework may undergo changes or modifications during the game construction process.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
,No 61,66 Ave,Pasdaran Blvd,
City
Shiraz
Province
Fars
Postal code
7184956516
Approval date
2019-05-20, 1398/02/30
Ethics committee reference number
IR.SUMS.REC.1398.332
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nutritional knowledge
Timepoint
The beginning and the end of the intervention
Method of measurement
Researcher-made questionnaire
Secondary outcomes
1
Description
Dietary habits
Timepoint
The beginning and the end of the intervention
Method of measurement
Feed Frequency Questionnaire
2
Description
Diet diversity
Timepoint
The beginning and the end of the intervention
Method of measurement
Three-day food record questionnaire
3
Description
Growth Indices
Timepoint
The beginning and the end of the intervention
Method of measurement
Scales and meter
Intervention groups
1
Description
Intervention group: One hour a day playing electronic nutrition educational game installed on mobile or tablet
Category
N/A
2
Description
Control group: Without any intervention from the researcher
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Preschools
Full name of responsible person
Maryam alsadat Riasatian
Street address
Pasdaran Blvd
City
Shiraz
Province
Fars
Postal code
7184956516
Phone
+98 71 3627 9629
Email
maryam_riasatian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam alsadat Riasatian
Street address
Pasdaran Blvd
City
Shiraz
Province
Fars
Postal code
7184956516
Phone
+98 71 3627 9629
Email
maryam_riasatian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam alsadat Riasatian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Pasdaran Blvd
City
Shiraz
Province
Fars
Postal code
7184956516
Phone
+98 71 3627 9629
Email
maryam_riasatian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam alsadat Riasatian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Pasadaran Blvd
City
Shiraz
Province
Fars
Postal code
7184956516
Phone
+98 71 3627 9629
Email
maryam_riasatian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam alsadat Riasatian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Pasdaran Blvd
City
Shiraz
Province
Fars
Postal code
7184956516
Phone
+98 71 3627 9629
Email
maryam_riasatian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Participants' general information and study protocol and informed consent form will be published in the thesis.
When the data will become available and for how long
End of study
To whom data/document is available
Students, professors and researchers
Under which criteria data/document could be used
Through the text of the thesis and the articles that will be published
From where data/document is obtainable
Authentic Journals and Library of Shiraz University of Medical Sciences
What processes are involved for a request to access data/document