Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000923662
Ethics application status
Approved
Date submitted
21/07/2014
Date registered
28/08/2014
Date last updated
28/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting Gross motor skills among toddlers in childcare settings. The Active Beginnings Pilot RCT.
Scientific title
Development of a fundamental movement skill program to enhance gross motor skill development and physical activity among children aged 1-3 years.
Secondary ID [1] 284856 0
nil
Universal Trial Number (UTN)
U1111-1158-3390
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gross Motor Skill Development in Toddlers 292254 0
Condition category
Condition code
Public Health 292597 292597 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this project is to develop a motor skill development resource for toddlers aged 1-3 years. The expected outcomes will be an evidence-based resource that meets the needs and wants of the community partner, Big Fat Smile. After development, educators will be trained in the area of toddler motor development for improved pedagogy and practice. Then, the toddlers will receive instruction in how to develop these motor skills, resulting in increased learning and motor skill development.

Participants will comprise toddlers aged 1-3 years from four Big Fat Smile Community Pre-schools: Stewart Street, Kenny Street, Warrawong, and Barrack Heights. Two services will be randomised to the intervention group and two to the control group. The control group will receive the training and the resource at the end of the intervention.
Toddlers will be asked to participate in a gross motor skills development intervention program.

Pre-intervention and post-intervention assessments of gross motor skills will be conducted using the Gross motor sub-scale of the Bayley Scale of Infant and Toddler Development. Assessments will be conducted in Intervention and control groups. The intervention will last for 9 weeks in which toddlers will be better instructed by educators in how to develop these motor skills, resulting in increased learning and motor skill development. During the intervention, a process evaluation will be done to assess feasibility and accessibility. This will involve the research assistant observing the number of sessions that were implemented and gathering feedback from the educators through informal discussions and an interview their thoughts regarding the resource and its implementation.
The educators will develop confidence in this area through working together with UOW researchers, enabling them to repeat this process when refining resources in the future (sustainability).

Educators will receive training through a group session, coordinated by the centre director. This session will be attended by all Educators. There will be one session of two hours training. The training will be instructed by Chief Investigator Tony Okely.

The toddler intervention duration and frequency will be a daily session of 10 minutes for the 9 week program.
Intervention code [1] 289655 0
Lifestyle
Comparator / control treatment
The control group will receive the training and the resource at the end of the intervention.
Assessments of gross motor skills will be conducted using the Gross motor sub-scale of the Bayley Scale of Infant and Toddler Development. Assessments will be conducted in Intervention and control groups, at baseline timepoint and 9 week follow up time point.

The Control group will receive their normal curriculum.


Control group
Active

Outcomes
Primary outcome [1] 292450 0
The purpose of this project is to develop and assess a gross motor skill development resource for toddlers aged 1-3 years. To assess the effect of the program on the toddlers they will perform an assessment of Gross Motor Skills at Baseline and followup.

Gross Motor Skills will be assessed using the Bayley Scale of Infant and Toddler Development. Areas to be assessed will be Jump, Kick and Balance. Two researchers and two assistants will assess the gross motor skills of the children included in this study. To reduce the chance in differences between ratings, and thereby influencing the inter-rater reliability, all assessors attended a two-hour training workshop and were provided opportunities to discuss and practice the measurements.
During baseline measurements all four assessors were blinded. At follow-up only the research assistants will be blinded, since the researchers will have been facilitating the ‘Active Beginnings’ program in the two intervention centres.
When assessing, the assessor will demonstrate each skill to the children and then the children will be asked to perform the skill to the best of their ability. While performing their balance, jump and kick skills, the assessor will then rate the different components of the skill according to the assessment tool.
This assessment will provide data on the impact of the resource on the children and effect the further development of the resource.

The expected outcome will be an evidence-based resource that meets the needs and wants of the community partner, Big Fat Smile.



No power calculations were performed since this is a pilot study and is not designed to detect statistically significant differences but rather to determine feasibility and acceptability of the resource.
Timepoint [1] 292450 0
Baseline data collection at start. Follow-up data collection at 10 weeks.
Secondary outcome [1] 308981 0
Feasability data: Data on the amount of children in the centres, the amount of eligible children and the amount of recruited children was collected. The retention rate was calculated after the follow-up measurements were completed. Additionally, feasibility data were collected through overall questions on the program and the resource at the end of the intervention period.

Timepoint [1] 308981 0
During intervention and at 10 week post intervention.
Secondary outcome [2] 309849 0
Acceptability data: During the intervention period the researcher collected data on acceptability by collecting data on the participation of the children and the educators in the experiences. Also data on the duration of the intentional learning experiences and the content were collected daily.

Educators from the intervention centres completed a standardized evaluation form after the facilitation of every gross motor skill. For some skills, this would be after two weeks, for others this would be after three weeks. Educators were asked to assess the different aspects of the resource including the appropriateness of the activities, the duration of the lessons and the equipment needed. Rating was done on a five scale, varying from highly inappropriate to highly appropriate. Additionally, they were asked to give suggestions for improvements and additional activities to add to the resource.
Timepoint [2] 309849 0
During intervention and at 10 week post intervention.

Eligibility
Key inclusion criteria
Participants must be actively enrolled in the nominated Big Fat Smile Childcare Centre. Participants must be aged between 1 to 3 years old.
Educators involved in assistting the implementation of the program must be actively employed by Big Fat Smile.
Minimum age
12 Months
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children participants must be within the eligible age range to participate.

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)
Simple randomisation using procedure used - Names of centres were written on paper and randomly selected from a box. This box was out of the line of sight of the person selecting the names.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using numbered containers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Approximately 50 children aged 1 and 3 years and six educators will be recruited across four Early Childhood services. Approximately 25 children will be from the intervention services and 25 from the control services

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
22/04/2014
Actual
22/04/2014
Date of last participant enrolment
Anticipated
6/05/2014
Actual
9/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8322 0
2500 - Wollongong
Recruitment postcode(s) [2] 8378 0
2528 - Barrack Heights
Recruitment postcode(s) [3] 8379 0
2502 - Warrawong

Funding & Sponsors
Funding source category [1] 289468 0
Other
Name [1] 289468 0
Big Fat Smile.
Country [1] 289468 0
Australia
Primary sponsor type
University
Name
University of Wollongong, School of Education, Faculty of Social Sciences, Faculty Research Grant.
Address
School of Education.
Northfields Ave.
University of Wollongong.
NSW, 2522, Australia
Country
Australia
Secondary sponsor category [1] 288156 0
None
Name [1] 288156 0
Address [1] 288156 0
Country [1] 288156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291226 0
The Social Sciences Human Research Ethics Committee, University of Wollongong
Ethics committee address [1] 291226 0
Ethics committee country [1] 291226 0
Australia
Date submitted for ethics approval [1] 291226 0
05/03/2014
Approval date [1] 291226 0
22/04/2014
Ethics approval number [1] 291226 0
HE14/068

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 95 95 0 0
/AnzctrAttachments/366587-Appendix A, Ver1 03-03-2014.docx
Attachments [2] 96 96 0 0
/AnzctrAttachments/366587-Appendix B, Ver 1 03-03-14.doc
Attachments [3] 97 97 0 0
/AnzctrAttachments/366587-Appendix C, Ver 1 03-03-14.doc
Attachments [4] 98 98 0 0
/AnzctrAttachments/366587-Appendix D, Ver 1 03-03-14.doc

Contacts
Principal investigator
Name 49406 0
Prof Tony Okely
Address 49406 0
Tony Okely.
School of Education
Faculty of Social Sciences.
Northfields ave
University of Wollongong
NSW
2522
Country 49406 0
Australia
Phone 49406 0
+61 02 42214641
Fax 49406 0
Email 49406 0
[email protected]
Contact person for public queries
Name 49407 0
Tony Okely
Address 49407 0
Tony Okely.
School of Education
Faculty of Social Sciences.
Northfields ave
University of Wollongong
NSW
2522
Country 49407 0
Australia
Phone 49407 0
+61 02 42214641
Fax 49407 0
Email 49407 0
[email protected]
Contact person for scientific queries
Name 49408 0
Tony Okley
Address 49408 0
Tony Okely.
School of Education
Faculty of Social Sciences.
Northfields ave
University of Wollongong
NSW
2522
Country 49408 0
Australia
Phone 49408 0
+61 02 42214641
Fax 49408 0
Email 49408 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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