ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001083381

Ethics application status

Approved

Date submitted

17/07/2017

Date registered

26/07/2017

Date last updated

19/07/2019

Date data sharing statement initially provided

19/07/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Physical Activity & Fundamental Motor Skills in Preschoolers: The PLAYFun Program

Scientific title

Effect of a physical activity and fundamental motor skills intervention on motor skills in preschoolers: The PLAYFUN Program

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

PLAYFUN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

motor skill development

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

12-week fundamental motor skills intervention for preschoolers aimed at improving motor skills and increasing physical activity. The intervention will consist of games designed to enhance the participants motor skills using equipment such as a variety of sports balls, witches hats, and jumping sacks. The intervention will run in the UNSW Early Years Childcare centres 5 days/week for 40 minutes with children to attend on the days they are present at the centre (between 1 and 5). The intervention will be run by an accredited exercise physiologist with assistance from 4th year exercise physiology practicum and research students.

Following the initial 12-week intervention period there will be a 12-week break followed by testing to investigate any ongoing effects of the program. Following this testing the original control group will be crossed over and receive the intervention. Further recruitment took place at this stage, and these children if eligible also took part. This group will only receive the 12-week intervention and not be assessed following a 12-week break.

Intervention code [1]

Lifestyle

Comparator / control treatment

The wait-list control group will initially receive their normal childcare curriculum: what the centres have developed as their curriculum based on the NSW government structures. They will receive the program following the 24-week from baseline follow-up assessment.

Control group

Active

Outcomes

Primary outcome [1]

Fundamental motor skills assessed by Test of Gross Motor Development 2 (TGMD-2)

Timepoint [1]

Baseline (week 0), post-intervention (week 12), and follow up (24 weeks)

Primary outcome [2]

Physical activity levels assessed by accelerometry and Preschool-Aged Children Physical Activity Questionnaire (PrePAQ)

Timepoint [2]

Baseline (week 0), post-intervention (week 12), and follow up (24 weeks)

Secondary outcome [1]

Body mass index measured by height and weight

Timepoint [1]

Baseline (week 0), post-intervention (week 12), and follow up (24 weeks)

Eligibility

Key inclusion criteria

Healthy children with no chronic conditions that would affect the child's participation in physical activity.
Age 3-5 and enrolled in the UNSW early years centers

Minimum age

3 Years

Maximum age

5 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Chronic condition that affects participants involvement in physical activity.
Diagnosed behavioral condition

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Study design: Recruitment -> Baseline Testing -> Cluster Randomization -> 12-week Intervention or Wait list Control -> Post Intervention Testing -> 12-week wait period -> follow up testing (original intervention group drop out at this point) -> second recruitment w baseline testing (joined original wait list control) -> 12-week intervention-> Post intervention testing

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

7/12/2016

Date of last participant enrolment

Anticipated

28/08/2017

Actual

20/08/2017

Date of last data collection

Anticipated

1/12/2017

Actual

24/11/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of NSW

Address [1]

Sydney NSW 2052

Country [1]

Australia

Primary sponsor type

Individual

Name

Alexander Engel

Address

Level 2 West. Wallace Building UNSW, Sydney NSW 2052

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of New South Wales

Address [1]

Sydney NSW 2052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW Human Research Ethics Committee

Ethics committee address [1]

Sydney NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/06/2016

Approval date [1]

04/08/2016

Ethics approval number [1]

HC16537

Summary

Brief summary

This project will involve a FMS program that will be implemented at the UNSW Early Years Childcare Centres. PLAYFUN will be a cluster randomised controlled trial in preschool aged children to be conducted over a 12-week period with fundamental motor skill testing to be completed at the beginning and end of the 12 weeks, with follow-up testing to be completed 12-weeks after the program has finished. If the program is shown to be beneficial, children in the control group will be offered the exercise program free of charge at the end of the study. Therefore, initially the control groups will be allocated as wait list for the program.
The primary outcome measure will be FMS measured using the Test of Gross Motor Development 2 (TGMD-2). Secondary outcome measures include both perceived and actual physical activity (PA) levels and anthropometric data (BMI).

Trial website

Trial related presentations / publications

Public notes

It should be noted that participants that started as controls and then crossed over to receive the intervention only received the 12-week intervention and were not assessed following a 12-week break. Participants who were enrolled at this stage also only took part in the 12-week intervention with no follow up.

Contacts

Principal investigator

Name

Mr Alexander Engel

Address

Level 2 West. Wallace Building UNSW, Sydney NSW 2052

Country

Australia

Phone

+61 423 771 797

Fax

alexander.engel@unsw.edu.au

Contact person for public queries

Name

Alexander Engel

Address

Level 2 West. Wallace Building UNSW, Sydney NSW 2052

Country

Australia

Phone

+61 423 771 797

Fax

alexander.engel@unsw.edu.au

Contact person for scientific queries

Name

Alexander Engel

Address

Level 2 West. Wallace Building UNSW, Sydney NSW 2052

Country

Australia

Phone

+61 423 771 797

Fax

alexander.engel@unsw.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3192	Study protocol		https://www.longdom.org/open-access/study-protocol-the-effect-of-a-fundamental-motor-skills-intervention-in-a-preschool-setting-on-fundamental-motor-skills-and-physic-2572-0775-1000129.pdf	alexander.engel93@y7mail.com		373316-(Uploaded-17-07-2019-15-46-42)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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