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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
Date results information 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] 292448 0
Nil
Universal Trial Number (UTN)
Trial acronym
PLAYFUN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
motor skill development 304059 0
Condition category
Condition code
Public Health 303385 303385 0 0
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] 298625 0
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] 302772 0
Fundamental motor skills assessed by Test of Gross Motor Development 2 (TGMD-2)
Timepoint [1] 302772 0
Baseline (week 0), post-intervention (week 12), and follow up (24 weeks)
Primary outcome [2] 302848 0
Physical activity levels assessed by accelerometry and Preschool-Aged Children Physical Activity Questionnaire (PrePAQ)
Timepoint [2] 302848 0
Baseline (week 0), post-intervention (week 12), and follow up (24 weeks)
Secondary outcome [1] 336980 0
Body mass index measured by height and weight
Timepoint [1] 336980 0
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297018 0
University
Name [1] 297018 0
University of NSW
Address [1] 297018 0
Sydney NSW 2052
Country [1] 297018 0
Australia
Primary sponsor type
Individual
Name
Alexander Engel
Address
Level 2 West. Wallace Building UNSW, Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 296016 0
University
Name [1] 296016 0
University of New South Wales
Address [1] 296016 0
Sydney NSW 2052
Country [1] 296016 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298203 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 298203 0
Sydney NSW 2052
Ethics committee country [1] 298203 0
Australia
Date submitted for ethics approval [1] 298203 0
20/06/2016
Approval date [1] 298203 0
04/08/2016
Ethics approval number [1] 298203 0
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 76322 0
Mr Alexander Engel
Address 76322 0
Level 2 West. Wallace Building UNSW, Sydney NSW 2052
Country 76322 0
Australia
Phone 76322 0
+61 423 771 797
Fax 76322 0
Email 76322 0
alexander.engel@unsw.edu.au
Contact person for public queries
Name 76323 0
Mr Alexander Engel
Address 76323 0
Level 2 West. Wallace Building UNSW, Sydney NSW 2052
Country 76323 0
Australia
Phone 76323 0
+61 423 771 797
Fax 76323 0
Email 76323 0
alexander.engel@unsw.edu.au
Contact person for scientific queries
Name 76324 0
Mr Alexander Engel
Address 76324 0
Level 2 West. Wallace Building UNSW, Sydney NSW 2052
Country 76324 0
Australia
Phone 76324 0
+61 423 771 797
Fax 76324 0
Email 76324 0
alexander.engel@unsw.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
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 3192 0
Study protocol
Citation [1] 3192 0
Email [1] 3192 0
alexander.engel93@y7mail.com
Other [1] 3192 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary