Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001009202
Ethics application status
Approved
Date submitted
1/06/2018
Date registered
15/06/2018
Date last updated
8/04/2020
Date data sharing statement initially provided
27/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
"Thinking while Moving in English": Evaluation of a school-based program that integrated physical activity across the primary school curriculum
Scientific title
"Thinking while Moving in English": Evaluation of a school-based program that integrated physical activity across the primary school curriculum
Secondary ID [1] 295041 0
Nil
Universal Trial Number (UTN)
Trial acronym
TWM-E
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity levels across the school day 308080 0
Condition category
Condition code
Public Health 307127 307127 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "Thinking While Moving in English" involves the integration of PA in primary school curriculum. Classroom teacher will be primarily responsible for the delivery of the program during normal English lessons. The program will run for 6 weeks. Primary school children will participate in active English lessons, that integrate physical activity during regular English lessons. The intervention lessons will run for 3 x 40 minutes per week over 6 weeks and will be delivered to the whole class during curriculum time.
TWM-E involves the modification of Stage 2 unit of work that will be developed from the NSW Board of Studies k-6 syllabi to maximise and create opportunities to integrate physical activity and enhance learning. Teaching ideas and resources will be supplied by the research team. Following the randomisation of the participant schools all baseline assessments will be undertaken.

Two professional development days will be carried out prior to the research project. All costs will be met by the University of Newcastle.
Dr. Nicholas Riley, University lecturer with 20 years of Primary School experience will deliver the professional learning workshop alongside other members of the research team.
The PL will consist of presentations and videos describing the benefits of including PA during learning, as well as examples of activities for teachers. Teachers will then plan and modify their existing unit of work with peer support. The PL will be delivered in all participating teachers as a group. A weekly email will be send to teachers to ensure the smooth delivery of the program. Additionally fortnightly fidelity checks will occur culminating in an open discussion between teachers and researchers.
Overall, the PL workshops will focus on the key principles of teaching of movement-based learning activities. Control schools will receive this workshop on the completion of the program. All schools will be provided with all lesson plans and a physical activity equipment pack containing all teaching resources (balls, drill ladders, stop watches, tape measures.The project will use a group randomised control trial. Schools will be randomly allocated to intervention or comparison groups for the study duration. Students and teachers in the control group will be provided all program information and resources following the collection of post-test data.

The following research methodologies will be used:

Physical activity (PA): Accelerometers will be used to provide an objective measure of both PA intensity and duration. Accelerometers are light instruments, small and robust that measure physical activity ( Freedson, Prober & Janz, 2005). Accelerometers will be worn throughout the school day.

On task behaviour: will be observed using a momentary time sampling procedure adapted from Behaviour Observation of students in Schools and Applied Behaviour Analysis for Teachers (Alberyo and Troutman) Students will be chosen at random and will be observed in 15 second intervals over a 30 minute period pre, during and post intervention
Academic performance: Academic performance in English will be measured using an ACER Progressive Achievement test in English delivered by the classroom teacher (Written Spelling, Punctuation & Grammar).

Enjoyment of English Survey: Students enjoyment of English will be evaluated using an attitude scale.

Evaluation: All students will be asked to complete an evaluation survey at the completion of the program.

Cognitive Assessments will be measured using the National Institute of Health (NIH) Toolbox for 7-17 years, which includes assessments of attention, cognitive control, episodic and working memory, language, and processing speed.
Intervention code [1] 301375 0
Behaviour
Intervention code [2] 301376 0
Prevention
Comparator / control treatment
Wait list control. Schools in the control group will receive the intervention at the completion of the study. During the intervention period the control schools will follow their usual school curriculum.

The control group will be offered the intervention after the 6-week intervention period. This will be in the form of registered professional learning and provision of lesson plans preparedby the research team.
Control group
Active

Outcomes
Primary outcome [1] 306081 0
The impact of TWM-E on children's daily school time PA levels.

Physical activity (PA) intensity : Accelerometers will be used to provide an objective measure of both PA intensity. Accelerometers will be worn throughout the school day.
Timepoint [1] 306081 0
Baseline and immediate post-test (6 weeks from baseline measures)
Primary outcome [2] 306160 0
The impact of TWM-E on children's daily school time PA levels.

Physical activity (PA) duration: Accelerometers will be used to provide an objective measure of PA duration. Accelerometers will be worn throughout the school day.
Timepoint [2] 306160 0
Baseline and 6-week post-test
Secondary outcome [1] 347496 0
The impact of the program on children's on-task behavior

On task behaviour: will be observed using a momentary time sampling procedure adapted from Behaviour Observation of students in Schools and Applied Behaviour Analysis for Teachers. Students will be chosen at random and will be observed in 15 second intervals over a 30 minute period pre, during and post intervention
Timepoint [1] 347496 0
Baseline and 6-week post-intervention
Secondary outcome [2] 347497 0
The effect of the program on children’s enjoyment of English.

Enjoyment of English Survey: Students enjoyment of English will be evaluated using an attitude scale especially designed for the purpose of this study
Timepoint [2] 347497 0
Baseline and 6-week post-intervention
Secondary outcome [3] 347499 0
Academic performance: Academic performance in English will be measured using an ACER Progressive Achievement test in English (Written Spelling, Grammar and Punctuation) delivered by the classroom teacher.
Timepoint [3] 347499 0
Baseline and 6-week post intervention
Secondary outcome [4] 347500 0
Cognition will be measured using the National Institute of Health (NIH) Toolbox for 7-17 years, which includes assessments of attention, cognitive control, episodic and working memory, language, and processing speed.
2 assessments will be used for this age group: Flanker Inhibitory Control and Attention test, and Dimensional Change Card Sort test
Timepoint [4] 347500 0
Baseline and 6-week post intervention

Eligibility
Key inclusion criteria
Stage 2 Primary School Children (Year 3 and 4)
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All students from Stage 2 classes in the study will participate in the program.
However only students who have provided consent letters will complete the assessments.

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)
The researcher will invite 10 schools of similar size from a variety of demographic locations, all within 60 minutes’ drive from The University of Newcastle, Callaghan Campus; The 10 schools will all be from the public sector. The research team will then randomly assign four schools to control and four schools to the intervention group.
The Classroom Teacher will be primarily responsible for the delivery of the program during normal lessons. TWM-E will involve the modification of a stage 2 unit of work that will be developed from the NSW Board of Studies k-6 syllabi to maximise and create opportunities to integrate physical activity and enhance learning. All teaching plans and resources will be supplied by the research team.
Following the randomisation of the participant schools all baseline assessments will be undertaken.
Two professional development days will be carried out prior to the research project. All costs will be met by the University of Newcastle. These days will focus on the key principles of teaching of movement-based learning activities. Control schools will receive this workshop on the completion of the program.
All schools will provided with all lesson plans and a physical activity equipment pack containing all teaching resources (balls, drill ladders, stop watches, tape measures).
Allocation concealment will be carried out by an independent researcher using a simple computer algorithm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple computer algorithm allocation will be conducted to allocate schools to either control or the treatment conditions. This method will ensure all schools have an equal liklehood of allocation to control or intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data obtained via accelerometers will be analysed and comparisons of the intervention and control groups will be made using the data from the pre -test and post- test assessments. Using the Statistical Package for Social Sciences (SPSS). Data analysis will explore preliminary associations between key variables using bivariate correlations. To determine the treatment effect of TWM-E analysis of co-variance will be used.

Power analysis using procedures appropriate for a RCT study design were conducted to determine the sample size required to detect changes in the primary outcome of accelerometer-determined physical activity. Calculations assumed baseline to post-test correlation scores of r = 0.30 and were based on 80% power and alpha level 0.05. Based on the reported physical activity effects (i.e., SD change = 200 counts per minute) after six weeks of the “Thinking While Moving in Maths” study (aka EASY Minds) pilot study and an intra-class correlation coefficient (ICC = 0.15), a study sample of N = 200 with 8 clusters (i.e., schools) of 25 students would provide adequate power to detect a between group difference of 200 counts per minute across the school day.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2018
Date of last participant enrolment
Anticipated
Actual
28/09/2018
Date of last data collection
Anticipated
Actual
28/09/2018
Sample size
Target
300
Accrual to date
Final
288
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299624 0
Government body
Name [1] 299624 0
NSW Department of Education
Country [1] 299624 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,

Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 298945 0
None
Name [1] 298945 0
Address [1] 298945 0
Country [1] 298945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300523 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 300523 0
Ethics committee country [1] 300523 0
Australia
Date submitted for ethics approval [1] 300523 0
12/07/2017
Approval date [1] 300523 0
29/03/2018
Ethics approval number [1] 300523 0
H-2017-0240

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83938 0
Dr Myrto Mavilidi
Address 83938 0
University Drive,
Callaghan,

University of Newcastle
NSW 2308
Country 83938 0
Australia
Phone 83938 0
+61249216242
Fax 83938 0
Email 83938 0
[email protected]
Contact person for public queries
Name 83939 0
Nicholas Riley
Address 83939 0
University Drive,
Callaghan,

University of Newcastle
NSW 2308
Country 83939 0
Australia
Phone 83939 0
+612 4985 4254
Fax 83939 0
Email 83939 0
[email protected]
Contact person for scientific queries
Name 83940 0
Nicholas Riley
Address 83940 0
University Drive,
Callaghan,

University of Newcastle
NSW 2308
Country 83940 0
Australia
Phone 83940 0
+612 4985 4254
Fax 83940 0
Email 83940 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.