Protocol summary

Study aim
Investigating the effect of indoor and outdoor physical activity on motor, cognitive and social development of preschool children
Design
After selecting two groups of children from 4.5 to 6.5 years old based on the conditions of entry into the study, from the two spaces mentioned above, the two groups will be homogeneous according to the scores obtained from the dependent variables in order to select two homogeneous groups of 15 persons.
Settings and conduct
First, parents will receive a written consent to measure their motor, cognitive, and social development. At the beginning of the work, both groups will be taken as a pretest, tests related to the dependent variables of research The first group of outdoor physical activities will conduct their activities in the natural outdoor school open space for 12 sessions of 4 hours in a month. Nature school activities include various activities such as sand play, equestrian games, water play, interaction with animals, coloring and painting in a natural. The second group will also carry out activities in indoor indoor daycare for 12 sessions of 4 hours in painting, teaching and children's games.
Participants/Inclusion and exclusion criteria
condition of entry: healthy children among 4.5-6.5 years old condition of no-entry: having physical damaging, having behavioral and cognitive disorders.
Intervention groups
The statistical sample of this study will consist of preschool children aged 4.5-6.5 years old in Tabriz in two groups. The first group includes 15 registered students of the nature school of Tabriz University as an outdoor physical activity group and the second group includes 15 children, which will be called in a kindergarten and will be considered as a physical activity group in the indoor environment.
Main outcome variables
The effect of two different learning environments on children's motor, perceptual and social development

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190207042649N1
Registration date: 2019-04-29, 1398/02/09
Registration timing: registered_while_recruiting

Last update: 2019-04-29, 1398/02/09
Update count: 0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
Zahra Fathirezaie
Name of organization / entity
The university of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3339 3392
Email address
z.fathirezaie@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-05-18, 1398/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Physical Activity in Outdoor and Indoor Space on Motor, Perceptual and Social Development among Preschool Children
Public title
The Effect of Physical Activity in Outdoor and Indoor Space on Motor, Perceptual and Social Development among Preschool Children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
healthy children among 4.5-6.5 years old
Exclusion criteria:
having physical damaging having behavioral and cognitive disorders
Age
From 54 months old to 78 months old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tabriz University of Medical Sciences
Street address
29 bahman Blvd, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.TBZMED.REC.1397.1019

Health conditions studied

1

Description of health condition studied
There was not
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
"motor development"
Timepoint
pre test and post test (practical period in 30 days)
Method of measurement
" Bruininks-oseretsky Test of Motor Proficiency"

2

Description
"perceptual development'
Timepoint
pre test and post test (practical period in 30 days)
Method of measurement
"Visual-Motor Integration"

3

Description
"social development"
Timepoint
pre test and post test (practical period in 30 days)
Method of measurement
"vineland social maturity scale"

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: activity in outdoor space. Outdoor activities were that children played in a green garden for 12 session, each session was 4 hour for one month. The garden, which was called the Nature School, includes parts for children's play, including water games, playing soil, animal interactions, planting, balancing games, Carpentry, and so on.
Category
Lifestyle

2

Description
control group: activity in outdoor space.This group includes children registered in kindergarten. They also carried out 12 sessions of activities such as painting, manual work, etc. in an indoor environment.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Tabriz
Full name of responsible person
Kosar Abbaspour
Street address
29 Bahman Blvd, University of Tabruz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3392
Email
kosar.abbaspour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tabriz
Full name of responsible person
Asghar Asgari
Street address
29 bahman Blvd, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51566616471
Phone
+98 41 3339 3630
Email
asgari@tabrizu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tabriz
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
University of Tabriz
Full name of responsible person
Kosar Abbaspour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
29 Bahman Blvd, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3444 0545
Email
kosar.abbaspour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
zahra Fathirezaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
29 Bahman Blvd, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3393
Email
zahra.fathirezaie@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Zahra Fathirezaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
29 bahman Blvd, university of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3392
Email
zahra.fathirezaie@gmail.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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is available after being unidentifiable
When the data will become available and for how long
6 month
To whom data/document is available
researchers and Enthusiasts
Under which criteria data/document could be used
demanding with email
From where data/document is obtainable
Kosar Abbaspour
What processes are involved for a request to access data/document
demanding via email from Kosar Abbaspour
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