ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

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]

Change in The Movement Environment Rating Scale (MOVERS) scale

Timepoint [1]

6 months post randomisation

Primary outcome [2]

Change in the Movement Assessment Battery for Children 2 (MABC-2)

Timepoint [2]

6 months post randomisation

Primary outcome [3]

Change in accelerometer measured physical activity during early learning centre hours

Timepoint [3]

6 months post randomisation

Secondary outcome [1]

Change in executive function: inhibition, attention and visual-spatial working memory measured by the Early Years Toolbox

Timepoint [1]

6 months

Secondary outcome [2]

Change in educators Tolerance of Risk in Play Scale (TRiPS) questionnaire

Timepoint [2]

6 months post randomisation

Secondary outcome [3]

Change in child heart rate variability (heart rate sensor)

Timepoint [3]

6 months post randomisation

Secondary outcome [4]

Change in child cortisol levels (saliva sampling)

Timepoint [4]

6 months post intervention

Secondary outcome [5]

Change in Strengths and Difficulties Questionnaire (SDQ-2) :

Timepoint [5]

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]

4000 - Brisbane

Recruitment postcode(s) [2]

4217 - Gold Coast

Recruitment postcode(s) [3]

2484 - Murwillumbah

Recruitment postcode(s) [4]

4551 - Caloundra

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Edge Early Learning Centres

Address [1]

5/34 The Esplanade, Paradise Point QLD 4216

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Edge Early Learning centres

Address [2]

22 Marie Street, Milton QLD 4064

Country [2]

Australia

Primary sponsor type

University

Name

University of Canberra

Address

University Dr, Bruce, ACT, 2617

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Deakin University

Address [1]

221 Burwood Hwy, Burwood VIC 3125

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Canberra Human Research Ethics Committee

Ethics committee address [1]

University Dr, Bruce, 2617, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/03/2019

Approval date [1]

05/04/2019

Ethics approval number [1]

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

Dr Rohan Telford

Address

University of Canberra
University Drive,
Bruce, ACT 2617
Australia

Country

Australia

Phone

+61 413132501

Fax

rohan.telford@canberra.edu.au

Contact person for public queries

Name

Rohan Telford

Address

University of Canberra
University Drive,
Bruce, ACT 2617
Australia

Country

Australia

Phone

+61 413132501

Fax

rohan.telford@canberra.edu.au

Contact person for scientific queries

Name

Rohan Telford

Address

University of Canberra
University Drive,
Bruce, ACT 2617
Australia

Country

Australia

Phone

+61413132501

Fax

rohan.telford@canberra.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	A peer coach intervention in childcare centres enhances early childhood physical activity: The Active Early Learning (AEL) cluster randomised controlled trial.	2021	https://dx.doi.org/10.1186/s12966-021-01101-2
Embase	The effect of a 6-month physical literacy intervention on preschool children's gross and fine motor skill: The Active Early Learning randomised controlled trial.	2022	https://dx.doi.org/10.1016/j.jsams.2022.04.009

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically