Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000488202
Ethics application status
Approved
Date submitted
22/03/2018
Date registered
4/04/2018
Date last updated
4/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Active Games and Cognitive Development in Preschool Children
Scientific title
Do active games effect cognitive development in preschool children: a group randomised controlled trial
Secondary ID [1] 294342 0
Nil Known
Universal Trial Number (UTN)
U1111-1210-9549
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Executive functions 307068 0
Habitual physical activity 307070 0
Condition category
Condition code
Public Health 306179 306179 0 0
Health promotion/education
Neurological 306180 306180 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 x 20-30min sessions per week of physically active and cognitively engaging games over 6 weeks in small groups (5-10 children).

Over a period 6 weeks the investigators will visit intervention preschool centres two times per week to deliver 2 small group active game sessions (5-10 children for 20-30 minutes). The games will provide a cognitive challenge to pre-schoolers, requiring them to use executive functions (i.e., working memory, inhibition, and shifting) while being physically active. The active games will be age-appropriate experiences developed from the research team's background in early childhood and physical education. Active games will be delivered by an Early Childhood Teacher with 23yrs experience and a 4th Year Early Childhood Honours Student.

An example active game is described below.
Fruit Hoops
- Hoops of 2 colours are in a circle (1 hoop per child), coloured fruit cards are in middle (2 x 2 - Apples/Bananas; Green/Yellow – 8 cards & hoops),
- Children move around outside of hoops to music (educator provides different locomotor movements)
- When the music stops – children move to closest hoop
Progression 1: Based on colour of hoop, children pick up a card of a matching colour
Progression 2: Based on colour of hoop, children pick up a matching fruit
Progression 3: Based on colour of hoop, children pick up the opposite colour
Progression 4: Based on colour of hoop, children pick up the opposite fruit

Intervention adherence will be assessed via: i) recording child attendance at intervention centres, ii) assessing physical activity during intervention sessions using accelerometry (fitted around children's waist for the duration of the intervention sessions), and iii) recording the progression level of each intervention activity, and thus the level of cognitive challenge of each intervention session.
Intervention code [1] 300658 0
Behaviour
Comparator / control treatment
Wait-list control. The controls group will be offered the intervention after the 6-week post-test assessments have been completed.
Control group
Active

Outcomes
Primary outcome [1] 305259 0
Executive function (4 domains - Visual-Spatial and Phonological working memory, inhibition and shifting) using the Early Years Toolbox tablet based e-games (http://www.eytoolbox.com.au)
Timepoint [1] 305259 0
6-week post test (end of June 2018 beginning of July 2018).
Secondary outcome [1] 344650 0
Pattern of neurophysiological activity - will be assessed using a portal, single dry electrode EEG, suitable for use with children in the field. EEG recordings will be collected during a resting task and during assessment of executive function assessments.
Timepoint [1] 344650 0
6-week post test (end of June 2018 beginning of July 2018).
Secondary outcome [2] 344741 0
Habitual Physical Activity - assessed using 7-day accelerometry (ActiGraph GT3X+) worn on the right hip around the waist using an elastic belt.
Timepoint [2] 344741 0
6-week post test (end of June 2018 beginning of July 2018).

Eligibility
Key inclusion criteria
Typically developing children aged between 4 years and 5.99 years of age will be included from preschools who are willing to participate in the study. Participating preschools will require at least 10 participating children to be involved in the study.
Minimum age
48 Months
Maximum age
71 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with conditions that might influence their cognitive development, physical activity or behaviour, and thus the results of the study, will not be included. Preschools with less than 20 preschoolers in the required age range in their service will not be eligible for the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation completed after pre-test. Allocation will involve contacting the holder of the allocation schedule (data manager external to the trial) who has no involvement with the trial and was not involved with recruitment or entering participants/services into the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Childcare centres will be pair-matched based on the area-level socio-economic status (Socio-Econonomoc Index For Areas, Index of Relative Socio-Econonomic Advantage/Disadvantage), and randomised as a pair to intervention or controls groups.

Wait-list control - control groups will receive intervention activities after 6-week post-test.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a pilot study, the sample size for the proposed trial is limited by available resources, and a sample size of 60 was determined to be adequate to demonstrate “proof of concept.” The investigators have demonstrated that children’s executive functions can be improved using non-physical-activity-based intervention strategies in experimental studies with similar sample sizes, so it is plausible that effects will be detected in the proposed study. Differences between groups will be tested using linear mixed models, accounting for relevant covariates (e.g., baseline outcome values) and preschool-level clustering. Because this pilot study will potentially be under-powered, effect sizes (Cohen's d) will also be used to demonstrate the magnitude of the effect.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/03/2018
Date of last participant enrolment
Anticipated
30/04/2018
Actual
Date of last data collection
Anticipated
6/07/2018
Actual
Sample size
Target
60
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22127 0
2519 - Balgownie
Recruitment postcode(s) [2] 22129 0
2516 - Bulli
Recruitment postcode(s) [3] 22130 0
2527 - Albion Park
Recruitment postcode(s) [4] 22154 0
2502 - Primbee

Funding & Sponsors
Funding source category [1] 298986 0
University
Name [1] 298986 0
UOW Faculty of Social Sciences Seed Grant
Country [1] 298986 0
Australia
Primary sponsor type
Individual
Name
Dylan Cliff
Address
School of Education, Faculty of Social Sciences,
University Of Wollongong
Northfields avenue
Wollongong, NSW 2522 Australia
Country
Australia
Secondary sponsor category [1] 298328 0
None
Name [1] 298328 0
Address [1] 298328 0
Country [1] 298328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299915 0
UOW & ISLHD Social Sciences Human Research Ethics Committee
Ethics committee address [1] 299915 0
Ethics committee country [1] 299915 0
Australia
Date submitted for ethics approval [1] 299915 0
28/06/2017
Approval date [1] 299915 0
28/02/2018
Ethics approval number [1] 299915 0
2017/313

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2518 2518 0 0
/AnzctrAttachments/374729-PreschoolPACognition_PISconsent_V7_160218.docx (Participant information/consent)
Attachments [2] 2519 2519 0 0
/AnzctrAttachments/374729-PA Data Collection TRaining.docx (Protocol)
Attachments [3] 2520 2520 0 0
/AnzctrAttachments/374729-Ethics Approval.docx (Ethics approval)

Contacts
Principal investigator
Name 81974 0
Dr Dylan Cliff
Address 81974 0
Dr. Dylan Cliff
Early Start, School of Education, Faculty of Social Sciences
Room 120, Building 23. Northfields avenue
University Of Wollongong, Wollongong, NSW 2522 Australia
Country 81974 0
Australia
Phone 81974 0
+61 2 42215929
Fax 81974 0
+61 2 42213892
Email 81974 0
[email protected]
Contact person for public queries
Name 81975 0
Dylan Cliff
Address 81975 0
Dr. Dylan Cliff
Early Start, School of Education, Faculty of Social Sciences
Room 120, Building 23. Northfields avenue
University Of Wollongong, Wollongong, NSW 2522 Australia
Country 81975 0
Australia
Phone 81975 0
+61 2 42215929
Fax 81975 0
+61 2 42213892
Email 81975 0
[email protected]
Contact person for scientific queries
Name 81976 0
Dylan Cliff
Address 81976 0
Dr. Dylan Cliff
Early Start, School of Education, Faculty of Social Sciences
Room 120, Building 23. Northfields avenue
University Of Wollongong, Wollongong, NSW 2522 Australia
Country 81976 0
Australia
Phone 81976 0
+61 2 42215929
Fax 81976 0
0061242213892
Email 81976 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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