Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000193178
Ethics application status
Approved
Date submitted
8/02/2019
Date registered
11/02/2019
Date last updated
9/03/2021
Date data sharing statement initially provided
11/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian Joy of Moving program in specialist schools.
Scientific title
The Australian Joy of Moving program in Specialist Schools: A pilot randomised controlled trial of feasibility and acceptability.
Secondary ID [1] 297312 0
Nil known
Universal Trial Number (UTN)
U1111-1228-0792
Trial acronym
AJoM
Linked study record
This project is a sister-study to a project registered with this trial registry (project ACTRN12618000898257)

Health condition
Health condition(s) or problem(s) studied:
Psychological Wellbeing 311418 0
Condition category
Condition code
Mental Health 310045 310045 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 310046 310046 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Australian Joy of Moving program.
The Australian Joy of Moving (AJoM) program is a classroom based psychoeducational program that aims to get children moving more by engaging in a 10-minute classroom active break 4 days per week for 8 weeks of a school term. This will be during normal class time and will be administered by classroom teachers. Teachers will be provided with resources and instructions on how to administer the intervention. The intervention will involve teachers administering a psychoeducation component (a series of 8 storybooks [1 per week] designed specifically for this study) for approx. 2 mins of the 10-minute break which teaches children about the joy of moving and the benefits of using physical activity as a coping strategy for negative emotions. The remaining 8 minutes will consist of the class engaging in a fun, play-based movement activity which will be chosen by teachers. Teachers can choose from their own activities or from a series of activity cards provided by researchers. This intervention also includes 2 information sheets for primary caregivers provided by researchers which provide education about the benefits of their child engaging in physical activity and what the AJoM program involves for the child at school. These will be sent during the term that teachers roll out the AJoM program in the classroom.

Teachers allocated to the intervention group will be responsible for attending training and implementing the AJoM program with their class. Researchers will conduct training at the school on how to administer the materials and teachers will be given opportunities to ask questions face-to-face so that they are confident in how to roll out the intervention in their classroom. This training will be conducted at a time that suits the staff and will go for approximately 30 minutes. At this training session teachers will complete a hardcopy survey about their perception of the training session.

Researchers will visit intervention schools twice throughout the 8 weeks of the term that teachers are implementing the program to provide face-to-face support and also check for fidelity. Two researchers will observe the class engaging in the AJoM program and complete a brief questionnaire about implementation in the classroom. Teachers will also be asked to complete a logbook for the duration of the time they roll out the intervention to monitor adherence to the intervention.

Primary care-givers:
Primary care-givers will consent via a hardcopy or online form if they wish to participate in the evaluations of this program. Primary care-givers will then receive a survey link provided in an email in order to participate in this study. Primary care-givers will complete an online survey approx. 4-6 weeks before the roll out of the AJoM program. Primary care-givers that complete the pre-intervention survey will then be emailed the post intervention survey after roll out of the intervention.

Teachers:
Teachers will be asked to send home consent packages to parents, inviting them and their child to participate in the program. Teachers will also be invited to complete an online survey and a semi-structured interview with researchers approx. 4-6 weeks before the specified school term. Teachers that complete the pre-intervention survey will then be emailed the post intervention survey and will be invited to complete a second semi-structured interview after roll out of the intervention. Teachers will also be asked to complete a very brief survey 6 months after implementing the program to ascertain whether they are still using the program.

Children:
All children will engage in the intervention at school (or receive treatment as usual depending on randomisation) but only children whose primary care-givers consent to take part in the study will be evaluated. This will involve children completing a series of measures with a researcher during school time before and after the specified school term.
Intervention code [1] 313564 0
Behaviour
Intervention code [2] 313565 0
Lifestyle
Comparator / control treatment
A waitlist control group will be used in this trial. If allocated to the waitlist control group, primary care-givers and teachers will still be invited to complete the surveys pre and post the specific school term, following the same procedure as the intervention group. Children with caregiver consent will also complete measures with a researcher at school pre and post the specific school term. The children will not engage in the AJoM program during the specific term (as we need this group to be ‘treatment as usual’). However, the school will have access to the AJoM program 2 terms later, after the post intervention evaluations have been completed.
Teachers and parents in the waitlist control group will experience the same procedure as the participants in the intervention group when taking part in the intervention (after evaluations are complete). That is, the process of implementing the intervention will be the same where teachers will receive the same training on how to administer the activities and any resources required, as well as the same level of support. Parents/caregivers will receive the same information sheets from researchers.
Control group
Active

Outcomes
Primary outcome [1] 320692 0
The acceptability and feasibility of the Australian Joy of Moving program will be measured by a series of custom questions designed for children and teachers in this study. Semi-structured interviews with teachers will also be conducted to provide qualitative data around feasibility and acceptability.
Timepoint [1] 320692 0
The child questions will be administered by researchers to children approx. 4-6 weeks after the target school term and will be collected in schools. The teacher questions will be completed in an online survey approx. 4-6 weeks after the target school term. Researchers will provide a link to access the surveys. The semi-structured interviews with teachers will take place 4-6 weeks before and after the program.
Secondary outcome [1] 366485 0
Change in children’s motor proficiency will be measured by the Movement Assessment Battery for Children-2 (MABC-2; Henderson et al., 2007).
Timepoint [1] 366485 0
This will be administered by researchers to children approx. 4-6 weeks before and after the target school term and will be collected in schools.
Secondary outcome [2] 366486 0
Change in children’s understanding about and attitude towards physical activity will be measured by three custom questions designed for this study.
Timepoint [2] 366486 0
These will be administered by researchers to children approx. 4-6 weeks before and after the target school term and will be collected in schools.
Secondary outcome [3] 366490 0
Change in the amount of primary care-giver support for facilitating their children’s engagement in physical activity will be measured using a Parental support for physical activity scale and an Importance of physical activity scale (Trost, 2003).
Timepoint [3] 366490 0
This will be completed by primary care-givers in an online survey approx. 4-6 weeks before and after the target school term. Researchers will email a link to access the surveys.
Secondary outcome [4] 366491 0
Change in children’s physical activity participation outside of school will be measured by the Modified Physical Activity Questionnaire-Children (MPAQ-C; Leung, Chung, Ransdell, & Gao, 2016).
Timepoint [4] 366491 0
This will be completed by primary care-givers in an online survey approx. 4-6 weeks before and after the target school term. Researchers will email a link to access the surveys.
Secondary outcome [5] 366492 0
Change in teacher perception of student behaviour in the classroom will be measured using a shortened version of the Behavior and Assets of Students at the Classroom Level Scale (Lee et al., 2009).
Timepoint [5] 366492 0
This will be completed by teachers in an online survey approx. 4-6 weeks before and after the target school term. Researchers will provide a link to access the surveys.
Secondary outcome [6] 369177 0
Change in teachers sense of efficacy will be measured using the Teachers’ Sense of Efficacy Scale (Tschannen-Moran & Woolfolk Hoy, 2001).
Timepoint [6] 369177 0
Teachers will complete the Teachers' Sense of Efficacy Scale in an online survey approx. 4-6 weeks before and after the target school term.
Secondary outcome [7] 372539 0
Change in children’s enjoyment of physical activity will be measured by an adapted version of the Physical Activity for Children Enjoyment Scale (PACES; Motl et al., 2001).
Timepoint [7] 372539 0
This will be administered by researchers to children approx. 4-6 weeks before and 4-6 weeks after the target school term and will be collected in schools.
Secondary outcome [8] 372540 0
Change in children’s preferences for physical activity will be measured by the Preferences for Activities for Children (PAC; King et al., 2004).
Timepoint [8] 372540 0
This will be administered by researchers to children approx. 4-6 weeks before and 4-6 weeks after the target school term and will be collected in schools.

Eligibility
Key inclusion criteria
Children:
Students attending Specialist Schools across all primary years of schooling (grade prep-6 or aged 5-14 years) whose school Principal, classroom teacher and primary care-giver provide consent. Children must attend the specialist school at least 4 days per week.

Care-givers:
A primary caregiver of children attending a Victorian Specialist Primary school and class that has agreed to pilot the Australian Joy of Moving program.

Teachers:
Teachers of Victorian Specialist Primary schools that have agreed to pilot the Australian Joy of Moving program.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children:
Children who do not attend the specialist school at least 4 days per week (i.e. part time students). These children will be excluded as it is unlikely that they will be able to participate in the intervention program adequately (4 times per week).

Care-givers:
Parents of children who attend the specialist school less than 4 days per week.

Teachers:
There are no specific exclusion criteria.

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)
An independent person to the project will randomise participants (by school) using a computer-generated random number sequence to allocate to either the intervention group or the waitlist control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on estimates of an average of 104 primary aged students per school at Specialist schools in Victoria, and with an estimate of 50% participation rate, the sample size is likely to be 312 students across six Specialist schools. A 30% attrition rate is estimated which will reduce the sample to 218 students. With an intraclass correlation (ICC) of .0035 (based on previous research of Australian primary school children) the effective sample size is 216 participants. This effective sample size is sufficient to detect an effect of d = .38 or higher based on a calculation in G*Power with alpha as .05 and 80% power. Therefore, 216 students will be recruited.

We plan to analyse a series of feedback questions to determine the feasibility of and satisfaction with the intervention according to teacher report. We also plan to analyse group differences across outcomes (e.g. children’s preference and enjoyment of physical activity, motor proficiency and parental support for physical activity) between participants who receive and don’t receive the intervention to determine the effectiveness of the Australian Joy of Moving program for primary school aged children with special needs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2019
Actual
27/03/2019
Date of last participant enrolment
Anticipated
26/07/2019
Actual
24/07/2019
Date of last data collection
Anticipated
29/11/2019
Actual
7/07/2020
Sample size
Target
216
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301875 0
Commercial sector/Industry
Name [1] 301875 0
The Ferrero Group
Country [1] 301875 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 301625 0
None
Name [1] 301625 0
Address [1] 301625 0
Country [1] 301625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302567 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 302567 0
Ethics committee country [1] 302567 0
Australia
Date submitted for ethics approval [1] 302567 0
25/05/2018
Approval date [1] 302567 0
02/07/2018
Ethics approval number [1] 302567 0
2018-179
Ethics committee name [2] 302576 0
Department of Education and Training- Victoria
Ethics committee address [2] 302576 0
Ethics committee country [2] 302576 0
Australia
Date submitted for ethics approval [2] 302576 0
06/07/2018
Approval date [2] 302576 0
03/08/2018
Ethics approval number [2] 302576 0
2018_003791

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

Contacts
Principal investigator
Name 90682 0
Dr Nicole Papadopoulos
Address 90682 0
Deakin University
Level 4 Building BC
221 Burwood Highway, Burwood Victoria 3125
Country 90682 0
Australia
Phone 90682 0
+61 3 924 45295
Fax 90682 0
Email 90682 0
[email protected]
Contact person for public queries
Name 90683 0
Nicole Papadopoulos
Address 90683 0
Deakin University
Level 4 Building BC
221 Burwood Highway, Burwood Victoria 3125
Country 90683 0
Australia
Phone 90683 0
+61 3 924 45295
Fax 90683 0
Email 90683 0
[email protected]
Contact person for scientific queries
Name 90684 0
Nicole Papadopoulos
Address 90684 0
Deakin University
Level 4 Building BC
221 Burwood Highway, Burwood Victoria 3125
Country 90684 0
Australia
Phone 90684 0
+61 3 924 45295
Fax 90684 0
Email 90684 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
The data in this study is confidential and available only to members of the research team.


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.