Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001470280
Ethics application status
Approved
Date submitted
28/08/2018
Date registered
3/09/2018
Date last updated
28/10/2019
Date data sharing statement initially provided
28/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Fundamental Motor Skills Video Education for Parents Program: FUN MOVES Program
Scientific title
The effect of a parent video education program on motor skills in preschoolers: FUN MOVES Program
Secondary ID [1] 295705 0
Nil
Universal Trial Number (UTN)
Trial acronym
FUN MOVES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor Skill Development 309436 0
Condition category
Condition code
Public Health 308283 308283 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-week Intervention. Parents of participants will receive a video weekly for 12 weeks. The 2-minute long animated video will provide information on the fundamental motor skills and physical activity as well as break down how to teach one skill and provide ideas for games that can be used to practice the skill. The videos have been created specifically for this study.
Once they have received the video parents are then expected to demonstrate and practice the skill with their child. They will keep a log book of their activities tracking how long they practice each skill. The time spent on each skill is up to the discretion of the caregiver as the research team would like to see the effectiveness of the program in a real world setting. There are no strategies to assess adherence to the videos other than parents self report of having watched it in in their logbooks
Intervention code [1] 312258 0
Behaviour
Intervention code [2] 312259 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. The parents of the control group will receive all video content at the completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 307251 0
Fundamental motor skills assessed by Test of Gross Motor Development 2 (TGMD-2)
Timepoint [1] 307251 0
Baseline (week 0) and post-intervention (week 12)
Secondary outcome [1] 351269 0
Physical activity levels assessed by accelerometry and Preschool-Aged Children Physical Activity Questionnaire (PrePAQ)
Timepoint [1] 351269 0
Baseline (week 0) and post-intervention (week 12)
Secondary outcome [2] 351270 0
Body mass index measured by height and weight. Height will be measured using a stadiometer and weight measured on digital scales.
Timepoint [2] 351270 0
Baseline (week 0) and post-intervention (week 12)

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 and their parents of any age. There is no inclusion/exclusion criteria based on the parents.
Minimum age
3 Years
Maximum age
No limit
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2018
Date of last participant enrolment
Anticipated
1/03/2019
Actual
27/02/2019
Date of last data collection
Anticipated
7/06/2019
Actual
17/07/2019
Sample size
Target
60
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300292 0
University
Name [1] 300292 0
University of NSW
Country [1] 300292 0
Australia
Primary sponsor type
University
Name
University of NSW
Address
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 300010 0
None
Name [1] 300010 0
Address [1] 300010 0
Country [1] 300010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301325 0
UNSW Human Research Ethics and Compliance - Low risk
Ethics committee address [1] 301325 0
UNSW Sydney NSW 2052 Australia
Ethics committee country [1] 301325 0
Australia
Date submitted for ethics approval [1] 301325 0
Approval date [1] 301325 0
12/07/2018
Ethics approval number [1] 301325 0
HC180298

Summary
Brief summary
This project will involve a FMS program that will be implemented with the parents of children enrolled at the UNSW Early Years Childcare Centres. FUN MOVES will be a 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. Parents of children in the control group will be offered the videos 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

Contacts
Principal investigator
Name 85886 0
Mr Alexander Engel
Address 85886 0
Level 2 West. Wallace Building UNSW, Sydney NSW 2052
Country 85886 0
Australia
Phone 85886 0
+61 423771797
Fax 85886 0
Email 85886 0
[email protected]
Contact person for public queries
Name 85887 0
Alexander Engel
Address 85887 0
Level 2 West. Wallace Building UNSW, Sydney NSW 2052
Country 85887 0
Australia
Phone 85887 0
+61 423771797
Fax 85887 0
Email 85887 0
[email protected]
Contact person for scientific queries
Name 85888 0
Alexander Engel
Address 85888 0
Level 2 West. Wallace Building UNSW, Sydney NSW 2052
Country 85888 0
Australia
Phone 85888 0
+61 423771797
Fax 85888 0
Email 85888 0
[email protected]

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?

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
No additional documents have been identified.