Protocol summary
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Study aim
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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
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Design
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Clinical trial with two groups of intervention and control in 5-6 years old-parallel, no blinded and randomized groups-Based on e-learning
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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5-6 years old children, Shiraz resident, healthy and without any chronic, mental, motor or mental illnesses, Literate parents, access to Android mobile phone
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Intervention groups
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Intervention group: 5-6 years old children who play electronic games on their mobile phone or tablet one hour a day for six months.
Control group: 5-6-year-old children who do not receive any nutritional education from the researcher during the six-month intervention period.
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Main outcome variables
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Anthropometric measurement,
Dietary diversity score,
Dietary habits,
Nutritional Knowledge of children and parents.
General information
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Reason for update
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The sample size has been changed to 120 people (60 people in each group) after consulting again with the statistical consultant.
In the inclusion criteria for the fourth item, the word (healthy) has been removed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190810044496N1
Registration date:
2019-08-26, 1398/06/04
Registration timing:
prospective
Last update:
2022-12-09, 1401/09/18
Update count:
1
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Registration date
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2019-08-26, 1398/06/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-22, 1398/07/30
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Expected recruitment end date
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2019-12-21, 1398/09/30
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Actual recruitment start date
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2021-08-23, 1400/06/01
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Actual recruitment end date
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2021-09-23, 1400/07/01
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Trial completion date
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2022-03-20, 1400/12/29
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Scientific title
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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
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Public title
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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
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
5 to 6 year old children
Shiraz resident
Healthy and without any chronic and mental , motor and psychologicall disease
Literate parents
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
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Age
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From 5 years old to 6 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
120
Actual sample size reached:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Cluster randomization based on 4 educational areas of Shiraz
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2019-05-20, 1398/02/30
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Ethics committee reference number
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IR.SUMS.REC.1398.332
Health conditions studied
1
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Description of health condition studied
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Preschool children, nutritional knowledge, mobile-based education
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Nutritional knowledge
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Timepoint
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The beginning and the end of the intervention
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Method of measurement
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Researcher-made questionnaire
Secondary outcomes
1
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Description
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Dietary habits
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Timepoint
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The beginning and the end of the intervention
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Method of measurement
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Three-day food record questionnaire
2
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Description
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Diet diversity
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Timepoint
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The beginning and the end of the intervention
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Method of measurement
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Three-day food record questionnaire
3
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Description
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Growth Indices
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Timepoint
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The beginning and the end of the intervention
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Method of measurement
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Scales and meter
Intervention groups
1
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Description
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Intervention group: one hour of daily play with nutrition education electronic game installed on mobile phone or tablet for six months
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Category
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N/A
2
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Description
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Control group: Without any intervention from the researcher
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Participants' general information and study protocol and informed consent form will be published in the thesis.
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When the data will become available and for how long
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End of study
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To whom data/document is available
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Students, professors and researchers
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Under which criteria data/document could be used
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Through the text of the thesis and the articles that will be published
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From where data/document is obtainable
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Authentic Journals and Library of Shiraz University of Medical Sciences
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What processes are involved for a request to access data/document
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in-person
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Comments
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