Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000925640
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
An after-school program to promote physical activity, cognitive development, and academic achievement in children in Skoolzout Centres.

Scientific title
An after-school program to promote physical activity, cognitive development, and academic achievement in children in Skoolzout Centres: The Wollongong Sport Pilot Effectiveness Trial.
Secondary ID [1] 284545 0
nil
Universal Trial Number (UTN)
U1111-1156-6289
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 291809 0
Condition category
Condition code
Public Health 292171 292171 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over the past 6 years, our research team has developed an evidence-based after-school program called Wollongong Sport. The aim of this study is to evaluate the efficacy of Wollongong SPORT when implemented in Big Fat Smile after-school centres. We hypothesise that, over a 18 week period, children in centres randomised to implement Wollongong SPORT will significantly increase their after-school physical activity, academic performance and cognitive development compared with children in the control group.

Wollongong SPORT is a physical activity and academic enrichment program for 5-10 year-old children. It will be implemented three afternoons per week in the intervention centres.
The Program has two components: one is optional tutoring, and two is the physical activity sessions (90min). BFS Centre staff and pre- service UOW education students will be trained to implement the Program over a six-month period. The UOW students will be recruited through a compulsory 4th year undergraduate subject (EDSE401) in which they are required to complete a minimum of 30 hours of service in a local community-based organisation. The aim of the physical activity sessions is to engage children for at least 50% of the time in Moderate to Vigorous Physical Activity (MVPA), which is consistent with international policy and has been achieved in our pilot studies. Children will participate in team sports such as soccer and basketball, and activity sessions based on popular TV shows such as The Amazing Race and Survivor. All activities have been designed to be fun whilst at the same time challenging (both tactically and physiologically). There is an optional tutoring element available if the participant child wishes to take part in tutoring before the afternoon's sports session. The optional tutoring session will run for a maximum of 30 minutes. The sports program will run for 90 minutes. Giving a total program time of 2 hours, if the child takes part in the optional tutoring. Otherwise the participant will take part in up to 90 minutes of sports games.
Currently there are two intervention centres, requiring 6 students per centre to run the program. Each intervention centre will receive equipment up to the value of $500 to assist with running the program.

Physical activity and cognitive development data will be collected at baseline and 6-month follow-up by trained research assistants blinded to group allocation. Physical activity will be measured during centre hours using the Actigraph accelerometer (worn on child’s hip using an elastic belt). Cognitive development will be measured using the Figural Intersections Task (a measure of working memory/attentional capacity). All instruments are valid and reliable among primary school-aged children.
Intervention code [1] 289306 0
Lifestyle
Comparator / control treatment
Centres randomised to the control group will continue with their usual after- school programs. The Wollongong SPORT Program, including $500 worth of equipment, will be provided to these centres at the end of the intervention period.

Physical activity and cognitive development data will be collected at baseline and 6-month follow-up by trained research assistants blinded to group allocation. Physical activity will be measured during centre hours using the Actigraph accelerometer (worn on child’s hip using an elastic belt). Cognitive development will be measured using the Figural Intersections Task (a measure of working memory/attentional capacity). All instruments are valid and reliable among primary school-aged children.
Control group
Active

Outcomes
Primary outcome [1] 292709 0
Physical activity data will be collected at baseline and 18 week follow-up by trained research assistants blinded to group allocation. Physical activity will be measured during centre hours using the Actigraph accelerometer (worn on child’s hip using an elastic belt). This data will be analysed to assess the effectiveness of the intervention of the sports program that has been implemented into the after school care centres. All instruments are valid and reliable among primary school-aged children.

Timepoint [1] 292709 0
baseline and follow-up at 18 weeks into the intervention.
Secondary outcome [1] 309535 0
Cognitive development will be measured using three tasks, presented as games. All instruments are valid and reliable among primary school-aged children.
The tasks (positioned as 'games') we will be administering measure executive functions (i.e., working memory, inhibition, shifting) and non-verbal performance intelligence/reasoning.
Details of the Executive Functioning tests are below:

The tasks (positioned as 'games') we will be administering measure executive functions (i.e., working memory, inhibition, shifting) and non-verbal performance intelligence/reasoning. The tasks are as follows:
-Matrix Reasoning Subtest of the Weschler Intelligence Scale for Children (non-verbal performance intelligence) - children are presented with an array of designs that form a pattern. Children are required to select the next design in the pattern from a range of options presented at the bottom of the page.
-Mr. Ant (visual-spatial working memory) - children see a cartoon ant with 1 to 8 coloured stickers on his person. Children are required to remember the placement of these stickers and, after a delay, indicate these spatial locations.
-Go/No-Go (inhibition) - children see a series of fish and sharks quickly swim across the screen. Children are required to 'catch' the fish (by tapping the screen) and 'avoid' the sharks (withhold tapping the screen). Because of the speeded nature of the task, and the majority of trials being go trials (fish), the prepotent tendency to respond needs to be overcome for no-go trails (sharks).
-Dimensional Change Card Sorting Task (shifting) - children are required to sort cards by one dimension (e.g., colour) before switching to a new sorting dimension (e.g., shape). If completed successfully, children are required to flexibly switch between colour and shape sorting rules on the basis of the presence/absence of a border around the stimulus.
Together, these 4 tasks take approximately 20 minutes to complete (in some cases shorter, due to stop rules). These measures will be administered at both baseline and follow-up.
Timepoint [1] 309535 0
Baseline and follow-up at 18 weeks into the intervention.
Secondary outcome [2] 309850 0
We will collect demographic data on the BFS staff and UOW students who delivered the program and on the facilities at each centre.
We will collect demographic data on the participants. Including Parent/Guardian employment status, marital status.
Timepoint [2] 309850 0
This data will be collected during the 18 week intervention.

Eligibility
Key inclusion criteria
Participants must be enrolled and attend the Intervention Centre. This is a Big Fat Smile After School Care Centre. Participants must attend two out of three specific days across the week. They must also be aged between 5 and 10 years old.
Minimum age
5 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are inelegible if they do not attend the centre on the correct number of specified days, or are out of the specified age range.

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)
Numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a Cohen’s d effect size of 0.4 (i.e. a moderate effect size) and a two-tailed, 5% alpha level test, a total sample size of approximately 104 children (52 in each group) would provide 80% power to detect an effect of at least this size. This calculation is based on estimating the effect of the F statistic of the interaction term in a repeated measures design, and is inflated to account for a mild intra-class correlation coefficient (ICC; 0.01) to reflect the group randomised design. As some attrition may occur, we will increase the sample by 15% for a total of 120 children (60 in each group or 30 per centre). This will require four centres to be recruited. Sample size calculations were done using G*Power and the adjustment for the ICC using the Killip formula.

Data analysis Plan: Each matching pair of Centres will be randomised to treatment or control group using the biased-coin method. As participants are treated within one group it is likely that, over time, their outcomes will be correlated and ignoring this correlation may result in an inflated type I error. Post hoc the ICC for the treatment arm will be estimated, however, a priori the results of the primary outcomes will be analysed using a mixed model approach where the group is included as a nested random effect and the degrees of freedom are altered based on the number of groups. Baseline measures and relevant covariates will be included with the treatment term in the model. The analysis will be conducted using PROC MIXED in SAS.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/05/2014
Actual
5/05/2014
Date of last participant enrolment
Anticipated
23/05/2014
Actual
23/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8213 0
2526 - Unanderra
Recruitment postcode(s) [2] 8214 0
2500 - West Wollongong
Recruitment postcode(s) [3] 8215 0
2500 - Wollongong West
Recruitment postcode(s) [4] 8216 0
2529 - Oak Flats

Funding & Sponsors
Funding source category [1] 289335 0
Other
Name [1] 289335 0
Big Fat Smile
Country [1] 289335 0
Australia
Primary sponsor type
University
Name
University of Wollongong URC/ESRI
Address
Northfields Ave, Univeristy of Wollongong. Wollongong. NSW 2522.
Country
Australia
Secondary sponsor category [1] 288322 0
None
Name [1] 288322 0
Address [1] 288322 0
Country [1] 288322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291107 0
The Social Sciences Human Research Ethics Committee, University of Wollongong
Ethics committee address [1] 291107 0
Ethics committee country [1] 291107 0
Australia
Date submitted for ethics approval [1] 291107 0
05/03/2014
Approval date [1] 291107 0
01/05/2014
Ethics approval number [1] 291107 0
HE14/067

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 63 63 0 0
/AnzctrAttachments/366264-14-067 Amendment Approval 090514.pdf
Attachments [2] 64 64 0 0
/AnzctrAttachments/366264-Appendix A PIS Final 02-05-14.docx
Attachments [3] 65 65 0 0
/AnzctrAttachments/366264-Appendix B Consent FINAL 02_05_2014.docx
Attachments [4] 66 66 0 0
/AnzctrAttachments/366264-Appendix E Survey Educators Ver1 29_01_2014.doc
Attachments [5] 67 67 0 0
/AnzctrAttachments/366264-Appendix F Survey Parents Ver2 02_06_2014.docx
Attachments [6] 146 146 0 0
/AnzctrAttachments/366264-14-067 Final Approval After Response to Review 010514.pdf
Attachments [7] 148 148 0 0
/AnzctrAttachments/366264-14-067 Amendment Approval 080514.pdf
Attachments [8] 149 149 0 0
/AnzctrAttachments/366264-14-067 Amendment Approval 100614.pdf

Contacts
Principal investigator
Name 48114 0
Prof Tony Okely
Address 48114 0
School of Education.
Building 22, room 106.
Northfields Ave,
University of Wollongong.
Wollongong.
NSW 2522.
Country 48114 0
Australia
Phone 48114 0
+61 02 42214641
Fax 48114 0
Email 48114 0
[email protected]
Contact person for public queries
Name 48115 0
Tony Okely
Address 48115 0
School of Education.
Building 22, room 106.
Northfields Ave,
University of Wollongong.
Wollongong.
NSW 2522.
Country 48115 0
Australia
Phone 48115 0
+61 02 42214641
Fax 48115 0
Email 48115 0
[email protected]
Contact person for scientific queries
Name 48116 0
Tony Okely
Address 48116 0
School of Education.
Building 22, room 106.
Northfields Ave,
University of Wollongong.
Wollongong.
NSW 2522.
Country 48116 0
Australia
Phone 48116 0
+61 02 42214641
Fax 48116 0
Email 48116 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePromoting Physical Activity and Executive Functions Among Children: A Cluster Randomized Controlled Trial of an After-School Program in Australia.2020https://dx.doi.org/10.1123/jpah.2019-0381
N.B. These documents automatically identified may not have been verified by the study sponsor.