Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000637741
Ethics application status
Approved
Date submitted
30/05/2013
Date registered
5/06/2013
Date last updated
5/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Encouraging Activity to Stimulate Young Minds Program (E.A.S.Y Minds Program): Evaluation of a school-based program that integrates physical activity across the primary school curriculum
Scientific title
Encouraging Activity to Stimulate Young Minds (E.A.S.Y Minds): Evaluation of a school-based program that integrates physical activity across the primary school curriculum

Secondary ID [1] 282595 0
Nil
Universal Trial Number (UTN)
Trial acronym
E.A.S.Y. Minds
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity Levels across the school day 289289 0
Condition category
Condition code
Public Health 289609 289609 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The E.A.S.Y. Minds Program involves the integration of PA in the Primary school curriculum. The Classroom Teacher will be primarily responsible for the delivery of the program during normal lessons. The program will run for 6 weeks.E.A.S.Y. Minds will involve the modification of a stage 3 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. 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.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:

Height and Weight: height will be measured using a portable stadiometer and weight will be measured using calibrated weight scales.

Learning Styles: will be measured using the Barsch Learning Style Reference Form (Barsch, 1991).From this, an indication of students preferred perceptual modality will be determined. Student’s intelligence strengths will be assessed using a Multiple Intelligences Checklist for Upper Primary and Secondary (MICUPS) (Mcgrath and Noble, 2005)

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

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.

Academic performance: Academic performance in Mathematics will be measured using an ACER Progressive Achievement test in Mathematics delivered by the classroom teacher.

Enjoyment of Maths Survey: Students enjoyment of maths will be evaluated using a validated mathematics attitude scale.

Evaluation: All teachers and Students will be asked to complete an evaluation survey at the completion of the program.
Intervention code [1] 287262 0
Behaviour
Intervention code [2] 287263 0
Prevention
Comparator / control treatment
Wait list control. Schools in the control group will recieve the intervention at the completion of the study. During the intervention period the control schools will their usual school curriculum.
Control group
Active

Outcomes
Primary outcome [1] 289701 0
The impact of EASY Minds on children’s daily school time PA levels.
Physical activity (PA): Accelerometers will be used to provide an objective measure of both PA intensity and duration. Accelerometers will be worn throughout the school day.
Timepoint [1] 289701 0
Baseline and Immediate post intervention (6 weeks from baseline measures)
Secondary outcome [1] 303052 0
The impact of the program on children’s on task behaviour.

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] 303052 0
Baseline and immediately post intervention.
Secondary outcome [2] 303125 0
The effect of the program on children’s enjoyment of mathematics.
Enjoyment of Maths Survey: Students enjoyment of maths will be evaluated using a validated mathematics attitude scale.
Timepoint [2] 303125 0
Baseline and immediately post intervention.
Secondary outcome [3] 303126 0
The feasibility of the EASY Minds program.
Process evaluation questionnaires.
Timepoint [3] 303126 0
Post intervention
Secondary outcome [4] 303127 0
Academic performance: Academic performance in Mathematics will be measured using an ACER Progressive Achievement test in Mathematics delivered by the classroom teacher.
Timepoint [4] 303127 0
Baseline and post intervention

Eligibility
Key inclusion criteria
Stage 3 Primary School Children (Year 5 and 6)
Minimum age
9 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All students from Stage 3 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 8 schools of similar size from a variety of demographic locations, all within 60 minutes’ drive from The University of Newcastle, Callaghan Campus; The 8 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. E.A.S.Y. Minds will involve the modification of a stage 3 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
Parallel
Other design features
Wait list Control. Participants assigned to control list will recieve the intervention at the completion of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data obtained via accelerometers will be analysed using meterplus software 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 E.A.S.Y. Minds analysis of co-variance will be used.
We are planning a study of a continuous response variable from independent control and experimental subjects with 1 control(s) per experimental subject. In a previous study the response within each subject group was normally distributed with standard deviation 250. If the true difference in the experimental and control means is 100, we will need to study 132 experimental subjects and 132 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.9. The Type I error probability associated with this test of this null hypothesis is 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287379 0
Self funded/Unfunded
Name [1] 287379 0
Country [1] 287379 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
The University of Newcastle
University Drive
CALLAGHAN
NSW
2308
Country
Australia
Secondary sponsor category [1] 286125 0
None
Name [1] 286125 0
Address [1] 286125 0
Country [1] 286125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289353 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 289353 0
Callaghan Campus
University drive
Callaghan
NSW
2308
Ethics committee country [1] 289353 0
Australia
Date submitted for ethics approval [1] 289353 0
Approval date [1] 289353 0
29/01/2013
Ethics approval number [1] 289353 0
H-2010-1183

Summary
Brief summary
To produce an evidenced based physical activity intervention for classroom teachers that will integrate PA across the primary school curriculum as highlighted in the Auditor General’s Report June 2012. The Easy Minds intervention has run a successful feasibility trial that demonstrated that integrating PA into other subjects can lead to: Increased moderate to vigorous physical activity (MVPA) within both the intervention session and the school day, reduce sitting time and improve classroom behaviour.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40434 0
Mr Nick Riley
Address 40434 0
HPE 3.11
University of Newcastle
School of Education
Callaghan Campus
University Drive
NSW
2308
Country 40434 0
Australia
Phone 40434 0
+61 2 49854254
Fax 40434 0
Email 40434 0
Nicholas.Riley@newcastle.edu.au
Contact person for public queries
Name 40435 0
Mr Nick Riley
Address 40435 0
HPE 3.11
University of Newcastle
School of Education
Callaghan Campus
University Drive
NSW
2308
Country 40435 0
Australia
Phone 40435 0
+61 2 49854254
Fax 40435 0
Email 40435 0
Nicholas.Riley@newcastle.edu.au
Contact person for scientific queries
Name 40436 0
Mr Nick Riley
Address 40436 0
HPE 3.11
University of Newcastle
School of Education
Callaghan Campus
University Drive
NSW
2308
Country 40436 0
Australia
Phone 40436 0
+61 2 49854254
Fax 40436 0
Email 40436 0
Nicholas.Riley@newcastle.edu.au

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
EmbaseRationale and study protocol of the EASY Minds (Encouraging Activity to Stimulate Young Minds) program: cluster randomized controlled trial of a primary school-based physical activity integration program for mathematics.2014https://dx.doi.org/10.1186/1471-2458-14-816
N.B. These documents automatically identified may not have been verified by the study sponsor.