Protocol summary

Study aim
Determine the effect of a Game-based nutrition education intervention on nutritional knowledge of 3-6 years old children in Shiraz kindergartens, 2016
Design
We will select 48 children from 8 kindergarten, who have the inclusion criteria. Then children will randomly allocated to experiment or control groups based on their socio-economic status.
Settings and conduct
We will use random stratified sampling. At first, we will divide the Shiraz to 4 regions and randomly select 2 kindergarten from each region. Thus, 8 kindergartens will selected from regions with different socioeconomic status. Then we randomly selected one kindergarten in each region as experiment and another as control group. Finally, we randomly selected 6 children in each kindergarten.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 3 to 6 years old children attended in selected kindergarten Non-inclusion criteria: Lack of mental illness and attention deficit disorder The absence of a child in kindergarten on designated dates Child's unwillingness to play the game and participation to study
Intervention groups
Participants were randomly allocated to experiment and control groups. The experiment group will use Snack and Ladder game, a computer based game contained nutrition education comments. Control group will took no intervention. Intervention duration will be 1 week, that experiment group play the game for 3 days/week and 30 minute during a day.
Main outcome variables
Nutrition knowledge of children

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180509039596N1
Registration date: 2018-06-13, 1397/03/23
Registration timing: retrospective

Last update: 2018-06-13, 1397/03/23
Update count: 0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Zahra Hassanzadeh-Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1007
Email address
zhasanzadeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a Game-based nutrition education intervention on nutritional knowledge of 3-6 years old children in Shiraz kindergartens, 2016
Public title
The effect of nutrition education on nutritional knowledge of children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
3 to 6 years old children attended in selected kindergarten
Exclusion criteria:
Lack of mental illness and attention deficit disorder The absence of a child in kindergarten on designated dates Child's unwillingness to play the game and participation to study
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
We will use random stratified sampling. At first, we will divide the Shiraz to 4 regions and randomly select 2 kindergarten from each region. Thus, 8 kindergartens will selected from regions with different socioeconomic status. Then we randomly selected one kindergarten in each region as experiment and another as control group. Finally, we randomly selected 6 children in each kindergarten.
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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.SUMS.REC.1395.171

Health conditions studied

1

Description of health condition studied
Nutritional knowledge of children
ICD-10 code
Z55.9
ICD-10 code description
Problems related to education and literacy, unspecified

Primary outcomes

1

Description
Nutritional knowledge of children
Timepoint
Baseline and end of intervention
Method of measurement
Picture based questionnaire of nutritional knowledge of children

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: playing the CD of Snake and Ladder game
Category
Other

2

Description
Control group: Non-playing a computere based game containing nutritional education messages
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kindergartens affiliated to the welfare organization
Full name of responsible person
Zahra Hassanzadeh-Rostami
Street address
Nutrition and Food Sciences School, Razi Street
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Hassanzadeh_z8@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
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
Zahra Hassanzadeh-Rostami
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Sciences School, Razi Street
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Hassanzadeh_z8@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Shiva Faghih
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Sciences School, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Shivafaghih@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hassanzadeh-Rostami
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition and Food Sciences School, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Hassanzadeh_z8@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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