Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000898257
Ethics application status
Approved
Date submitted
24/05/2018
Date registered
29/05/2018
Date last updated
16/12/2020
Date data sharing statement initially provided
3/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian Joy of Moving intervention in primary school children.
Scientific title
An evaluation of the Australian Joy of Moving program on getting primary school aged children moving for healthy development and wellbeing.
Secondary ID [1] 294570 0
None
Universal Trial Number (UTN)
U1111-1212-2127
Trial acronym
AJoM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological wellbeing 307436 0
Condition category
Condition code
Mental Health 306524 306524 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 306525 306525 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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. The AJoM intervention promotes the connection between movement and wellbeing using fun active breaks that are administered by the classroom teacher. 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 resources and instructions provided to teachers were specifically designed for this study. The intervention will involve teachers administering a psychoeducation component (a series of 8 storybooks and videos [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.

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/children:
Primary care-givers will consent and child assent via a hardcopy or online form if they wish for their child to participate in the evaluations of this program. Children will receive a hardcopy survey from the teachers to be completed in class approx. 4-6 weeks before the roll out of the AJoM program. Surveys will take 20 minutes. Children who complete the pre-intervention survey will then be given the post intervention survey after roll out of the intervention. During the program, children will also be asked to complete a 2 minute child diary, once a week for the duration of the program (8 weeks). For the intervention group this will occur immediately before and after the AJoM movement break. 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.

Teachers:
Teachers will be asked to send home consent packages to parents, inviting their child to participate in the program. Teachers will also be invited to complete an online or hardcopy survey and a semi-structured interview with researchers approx. 4-6 weeks before the specified school term. Surveys will take 20 minutes. Teachers that complete the pre-intervention survey and interview will then be emailed or sent 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.
Intervention code [1] 300910 0
Behaviour
Intervention code [2] 300911 0
Lifestyle
Comparator / control treatment
If they are in the Waitlist Control Group, teachers and children will be invited to complete the survey’s (using the same procedure as the intervention group) pre and post the specified school term, child diaries and teacher interviews. Child diaries will be completed once a week, immediately before and after any 10 minute period. Teachers and children will not engage in the AJOM program during the specific roll out term (as we need this group to be ‘treatment as usual’ for comparison). However, the school will have access to the AJOM program in the following term, after the surveys have been done.

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 surveys 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.
Control group
Active

Outcomes
Primary outcome [1] 305604 0
Change in classroom behaviour assessed by pre and post assessment questionnaire (The Behaviour and Assets of Students at the Classroom Level Scale). This measure has been validated to evaluate classroom behaviour for primary school aged children.
Timepoint [1] 305604 0
Teachers will complete a baseline survey (pre-assessment questionnaire) 4-6 weeks prior to the target school term, Information to access the survey online will be sent out by the researchers. Teachers will also have 4-6 weeks to complete a post assessment survey after the target school term,
Primary outcome [2] 305610 0
Changes in child wellbeing measured using the Strengths and Difficulties Questionnaire which has been validated in primary school aged children.
Timepoint [2] 305610 0
Children will complete a hardcopy baseline survey (pre-assessment questionnaire) 4-6 weeks prior to the target school term. Surveys will be handed out by teachers who receive them from researchers. Children will also have 4-6 weeks to complete a post assessment survey after the target school term,
Primary outcome [3] 306016 0
Changes in children's knowledge of mind body connection. This questionnaire has been specifically designed for this study.
Timepoint [3] 306016 0
Children will complete a baseline survey (pre-assessment questionnaire) 4-6 weeks prior to the target school term as part of their hardcopy survey. Surveys will be handed out by teachers who receive them from researchers. Children will also have 4-6 weeks to complete a post assessment survey after the target school term.
Secondary outcome [1] 347319 0
Changes in children's Enjoyment of Physical Activity using the Physical Activity Enjoyment Scale (PACES).
Timepoint [1] 347319 0
Children will complete a baseline survey (pre-assessment questionnaire) 4-6 weeks prior to the target school term as part of their hard copy survey. The survey will be handed out by teachers in class, who will receive surveys from the researchers. Children will also have 4-6 weeks to complete a post assessment survey after the target school term as part of their second hard copy survey,
Secondary outcome [2] 347421 0
The acceptability and feasibility of the intervention program (The Australian Joy of Moving program) will be measured using a custom survey designed for this study.
Timepoint [2] 347421 0
These questions will be included in an online survey that will be administered post intervention implementation to participants allocated to the intervention group.
Secondary outcome [3] 374468 0
Changes in teacher beliefs using the Teacher Self-Efficacy Scale
Timepoint [3] 374468 0
Teachers will complete a baseline survey (pre-assessment questionnaire) 4-6 weeks prior to the target school term, Information to access the survey online will be sent out by the researchers. Teachers will also have 4-6 weeks to complete a post assessment survey after the target school term,

Eligibility
Key inclusion criteria
Child inclusion criteria:
Primary school aged children (both male and female) attending a Victorian primary school that has agreed to pilot the Australian Joy of Moving program. We will recruit participants from public, catholic, private and independent primary schools in Victoria. Children must be aged 4-14 years.

Parent inclusion criteria:
Parents (of all ages both male and female) of children attending a Victorian primary school that has agreed to pilot the Australian Joy of Moving program.

Teacher inclusion criteria:
Teachers (of all ages, both male and female) of Victorian primary schools that have agreed to pilot the Australian Joy of Moving program.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child exclusion criteria:
There are no specific exclusion criteria. We would like to obtain a sample of convenience and will control for severity of emotional behavioural symptoms using our baseline measure of psychological functioning. The AJOM program has also been carefully developed/designed to be rolled out to all children including children with developmental difficulties.

Parent exclusion criteria:
There are no specific exclusion criteria.

Teacher exclusion criteria:
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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will randomise participants (by school) using a computer-generated random number sequence to be allocated to either the intervention program group or the waitlist control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our sample size will consist of at least 1000 participants. We calculated a power analysis using G power and found that to find a small effect size (0.2) with 80% power we will require a total sample size of 314 participants, therefore our anticipated sample size of 1000 (500 in the treatment group and 500 in the waitlist control group) will meet this requirement. This calculation will allow us to run group comparison analysis (t-test) which will allow us to compare the psychological wellbeing of the Australian Joy of Moving treatment group and the Waitlist control group pre and post intervention and ultimately evaluate the impact of the Australian Joy of Moving program.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
6/06/2018
Date of last participant enrolment
Anticipated
14/06/2021
Actual
Date of last data collection
Anticipated
20/09/2021
Actual
Sample size
Target
1000
Accrual to date
233
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299187 0
Commercial sector/Industry
Name [1] 299187 0
The Ferrero Group
Country [1] 299187 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 298450 0
None
Name [1] 298450 0
Address [1] 298450 0
Country [1] 298450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300111 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 300111 0
Ethics committee country [1] 300111 0
Australia
Date submitted for ethics approval [1] 300111 0
09/11/2017
Approval date [1] 300111 0
22/12/2017
Ethics approval number [1] 300111 0
2017-347
Ethics committee name [2] 301484 0
Department of Education and Training-Victoria
Ethics committee address [2] 301484 0
Ethics committee country [2] 301484 0
Australia
Date submitted for ethics approval [2] 301484 0
01/02/2018
Approval date [2] 301484 0
15/03/2018
Ethics approval number [2] 301484 0
2018_003620
Ethics committee name [3] 301485 0
Catholic Education Melbourne
Ethics committee address [3] 301485 0
Ethics committee country [3] 301485 0
Australia
Date submitted for ethics approval [3] 301485 0
31/05/2018
Approval date [3] 301485 0
08/06/2018
Ethics approval number [3] 301485 0
0776

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

Contacts
Principal investigator
Name 82606 0
Dr Nicole Papadopoulos
Address 82606 0
Deakin University
221 Burwood Highway, Burwood Victoria 3125
Country 82606 0
Australia
Phone 82606 0
+61 3 924 45295
Fax 82606 0
Email 82606 0
[email protected]
Contact person for public queries
Name 82607 0
Nicole Papadopoulos
Address 82607 0
Deakin University
221 Burwood Highway, Burwood Victoria 3125
Country 82607 0
Australia
Phone 82607 0
+61 3 924 45295
Fax 82607 0
Email 82607 0
[email protected]
Contact person for scientific queries
Name 82608 0
Nicole Papadopoulos
Address 82608 0
Deakin University
221 Burwood Highway, Burwood Victoria 3125
Country 82608 0
Australia
Phone 82608 0
+61 3 924 45295
Fax 82608 0
Email 82608 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.