Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000638134
Ethics application status
Approved
Date submitted
21/04/2019
Date registered
30/04/2019
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
ACTIVE EARLY LEARNING (AEL): evaluation of a physical literacy professional development and curriculum support program in early learning centres
Scientific title
ACTIVE EARLY LEARNING (AEL): A randomised controlled trial to evaluate a physical literacy professional development and curriculum support program for early learning centre educators
Secondary ID [1] 298024 0
Nil
Universal Trial Number (UTN)
U1111-1232-0748
Trial acronym
AEL (Active Early Learning) study
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
physical literacy 312477 0
Condition category
Condition code
Public Health 311023 311023 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early Learning Centre educators will receive professional development to deliver a physical literacy curriculum. Professional development will include four face to face training workshops and ongoing onsite support from a trained Active Early Learning coach for 4 hours once per week over a 6 month period. The provided curriculum materials specifically designed for this study will include a mixture of daily lesson and activity plans, free play and in-class cross-curricula physical activities targeting four areas of children's physical literacy (physical, social, cognitive and psychological). Adherence to monitor the intervention will include staff diaries and direct observation from the coach.
Intervention code [1] 314255 0
Behaviour
Comparator / control treatment
The control group early learning centres will not receive the physical literacy intervention and will continue with their usual practice curriculum activities
Control group
Active

Outcomes
Primary outcome [1] 319819 0
Change in The Movement Environment Rating Scale (MOVERS) scale
Timepoint [1] 319819 0
6 months post randomisation
Primary outcome [2] 319821 0
Change in the Movement Assessment Battery for Children 2 (MABC-2)
Timepoint [2] 319821 0
6 months post randomisation
Primary outcome [3] 319822 0
Change in accelerometer measured physical activity during early learning centre hours
Timepoint [3] 319822 0
6 months post randomisation
Secondary outcome [1] 369602 0
Change in executive function: inhibition, attention and visual-spatial working memory measured by the Early Years Toolbox
Timepoint [1] 369602 0
6 months
Secondary outcome [2] 369603 0
Change in educators Tolerance of Risk in Play Scale (TRiPS) questionnaire
Timepoint [2] 369603 0
6 months post randomisation
Secondary outcome [3] 369604 0
Change in child heart rate variability (heart rate sensor)
Timepoint [3] 369604 0
6 months post randomisation
Secondary outcome [4] 369605 0
Change in child cortisol levels (saliva sampling)
Timepoint [4] 369605 0
6 months post intervention
Secondary outcome [5] 369606 0
Change in Strengths and Difficulties Questionnaire (SDQ-2) :
Timepoint [5] 369606 0
6 months post randomisation

Eligibility
Key inclusion criteria
Children age 4 to 5 years attending an early learning centre and educators working with children age 4 to 5 years
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on early learning centre: location, number of children attending the centre and socio-economic status of the centre suburb
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
With regard to sample size calculations and statistical assumptions, The study statistical consultant makes the following comments: 1) It is not possible to undertake a formal power analysis with sufficient precision for the current study 2) Statistical knowledge gained from our previous work in the LOOK study (ACTRN12612000027819) indicates that 16 centres will ensure internal validity of the design i.e. there is sufficient information to estimate the 'experimental' error and intervention and control effects with adequate precision 3) At least 15 children in each centre is needed to estimate centre effects with high precision. Window of opportunity for testing at the start and the end of the year precludes greater numbers of schools and students.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2019
Actual
Date of last participant enrolment
Anticipated
24/05/2019
Actual
Date of last data collection
Anticipated
19/12/2019
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 26320 0
2484 - Murwillumbah
Recruitment postcode(s) [2] 26318 0
4000 - Brisbane
Recruitment postcode(s) [3] 26319 0
4217 - Gold Coast
Recruitment postcode(s) [4] 26321 0
4551 - Caloundra

Funding & Sponsors
Funding source category [1] 302552 0
Commercial sector/Industry
Name [1] 302552 0
Edge Early Learning Centres
Country [1] 302552 0
Australia
Funding source category [2] 302553 0
Commercial sector/Industry
Name [2] 302553 0
Edge Early Learning centres
Country [2] 302553 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University Dr, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 302460 0
University
Name [1] 302460 0
Deakin University
Address [1] 302460 0
221 Burwood Hwy, Burwood VIC 3125
Country [1] 302460 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303196 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 303196 0
University Dr, Bruce, 2617, Australia
Ethics committee country [1] 303196 0
Australia
Date submitted for ethics approval [1] 303196 0
14/03/2019
Approval date [1] 303196 0
05/04/2019
Ethics approval number [1] 303196 0
Project ID number: 1853

Summary
Brief summary
A multi-centre randomised design will be utilised to compare control centre normal practice conditions with intervention centres receiving physical literacy educator professional development and curriculum support. Approximately 60 educators and 300 children (age 4 to 5 years) will be recruited from 16 Early Learning Centres in Queensland and NSW. Centres will be randomly allocated (stratified cluster randomization) to either intervention, or control over a 24-week period. The reach, effectiveness, adoption, implementation, of the intervention will be examined. Change in aspects of children’s physical literacy will also be assessed. Assessments will be conducted at baseline and 6 months (end of intervention),It is hypothesised that educators receiving the intervention will improve the provision of physical literacy activities to children and that children receiving the intervention will have greater improvements in physical literacy.
Trial website
nil
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 92818 0
Dr Rohan Telford
Address 92818 0
University of Canberra
University Drive,
Bruce, ACT 2617
Australia
Country 92818 0
Australia
Phone 92818 0
+61 413132501
Fax 92818 0
Email 92818 0
rohan.telford@canberra.edu.au
Contact person for public queries
Name 92819 0
Dr Rohan Telford
Address 92819 0
University of Canberra
University Drive,
Bruce, ACT 2617
Australia
Country 92819 0
Australia
Phone 92819 0
+61 413132501
Fax 92819 0
Email 92819 0
rohan.telford@canberra.edu.au
Contact person for scientific queries
Name 92820 0
Dr Rohan Telford
Address 92820 0
University of Canberra
University Drive,
Bruce, ACT 2617
Australia
Country 92820 0
Australia
Phone 92820 0
+61413132501
Fax 92820 0
Email 92820 0
rohan.telford@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As the children and educators that will participate in this study will be enrolled in identifiable early learning centres, data they provide may be potentially identifiable. To ensure anonymity and privacy, individual data will not be available or disseminated.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of a 6-month physical literacy intervention on preschool children's gross and fine motor skill: The Active Early Learning randomised controlled trial.2022https://dx.doi.org/10.1016/j.jsams.2022.04.009
EmbaseA peer coach intervention in childcare centres enhances early childhood physical activity: The Active Early Learning (AEL) cluster randomised controlled trial.2021https://dx.doi.org/10.1186/s12966-021-01101-2
N.B. These documents automatically identified may not have been verified by the study sponsor.