Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000703404
Ethics application status
Approved
Date submitted
17/06/2025
Date registered
2/07/2025
Date last updated
2/07/2025
Date data sharing statement initially provided
2/07/2025
Date results provided
2/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and preliminary efficacy of the Muscle Movers program: A teacher-delivered intervention to support children's skills and participation in muscle-strengthening activity
Scientific title
Feasibility and preliminary efficacy of the Muscle Movers program: A teacher-delivered intervention to support children's skills and participation in muscle-strengthening activity
Secondary ID [1] 314680 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 337846 0
Condition category
Condition code
Public Health 334177 334177 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Muscle Movers is a 6-week, teacher-delivered school-based intervention designed to support primary school children’s development of muscle-strengthening activity (MSA) skills. Children participate in moderate-to-vigorous intensity activities, as they would during usual PE lessons. The intensity of physical activity is assumed, but not formally assessed. The intervention includes three components:

(1) A curriculum-aligned physical education (PE) program (1 × 45 mins/week), The PE program is structured around four foundational bodyweight exercises (‘Master Moves’) and supported by teacher and student resources including a handbook with lesson plans (designed specifically for this trial), skill cards outlining key skill criteria for perform the Master Moves, equipment pack (including cones, bean bags, bluetooth speaker, skipping ropes, balls, and fitness dice), and wall charts (1 x 'managers' chart for allocating students as 'helpers' to carry/set up equipment, and 1 x 'motivators' chart to publicly recognise students' demonstration of 'self-management' and 'interpersonal' skills, as outlined within the NSW K-10 PDHPE syllabus). Week 1 introduces students to all four Master Moves (i.e., Scorpion squat, Lemur Lunge, Python plank and Panther Push-up), weeks 2-5 focused on each Master Move individually in sequence, and Week 6 aims to consolidate students’ understanding of all Master Moves. PE lessons follow a format comprised of three parts: i) Start Strong, a fun/simple warm-up activity; ii) Main Muscles, the main body of the lesson focused on the allocated Master Move, involving explicit skill instruction, a short individual challenge activity, and a game-based skill application activity; and iii) Muscle-Up, a separate activity to add further variety. To address common barriers, PE lesson activities are intended to be simple to organise and explain, engaging for children, and able to be delivered with limited space and equipment. The Main Muscles lesson segment uses familiar minor games, adapted to incorporate fitness infusion (i.e., the inclusion of vigorous exercise, in our case via the Master Moves, in the context of game play). Teachers receive initial modelling of lesson delivery by a researcher in week 1 but independently deliver the program thereafter. The intervention is aligned with the NSW PDHPE curriculum and informed by behaviour change and pedagogical frameworks to promote skill development, engagement, and autonomy in a primary school setting.

(2) Classroom-based MSA energiser breaks (2 × 5 mins/week). Teachers deliver weekly movement breaks in the classroom on days the PE lesson is not being delivered. There are two 'styles' of energiser breaks: 'Would you rather' breaks are based on a distinct theme (e.g., food, occupations etc) and present students with two options to select from. Students chose which option ‘they’d rather’ and perform a corresponding exercise depicted on screen for 20 seconds (or until volitional failure). 'Rock, paper, scissors' breaks are based on the classic game, with students aiming to beat the result displayed on screen. After physically presenting their choice, one of the options is displayed on screen and students determine whether they won, lost or drew the round. They then perform an exercise corresponding with the appropriate outcome for 20 seconds (or until volitional failure). Each energiser includs five rounds and takes just under five minutes to complete. The breaks are teacher facilitated but supported by electronic resources (i.e., Microsoft PPT files) diplayed using a projector or smartboard. Slide transitions are pre-programmed so the teacher can simply press play, and then focus on encouraging students, and promoting correct exercise skill execution, rather than modelling all exercises.

(3) Active homework tasks (1 × 10 mins/week). Students complete 1 weekly home task, designed to facilitate self-directed practice of the 4 x Master Moves outside of the school setting, and supported by a hard copy student handbook. The student handbook includes six distinct activities. Example tasks includ: i) guessing the number of repetitions of a selected exercise that could be completed in a given timeframe and comparing guess with result, ii) selecting a song with a repetitive lyric and performing a self-selected exercise each time the lyric appeared when the song was played, iii) teaching a family member how to complete a self-selected Master Move by providing a demonstration and giving feedback using the information on the skill card within the handbook, iv) selecting household chores, allocating exercises to each, and completing self-selected repetitions to indicate to caregivers when the chore was completed, v) searching within home reader for words that rhyme with Master Moves and completing a repetition of the corresponding exercise when found, and vi) locating facts corresponding to the animals linked to Master Moves and completing repetitions after recording the fact in the handbook.

Teacher monitoring of adherence: Teachers log their completion and rate their satisfaction with each of the PE lesson activities within the teacher handbook. The handbook is returned to the research team to ascertain teachers' completion of the PE lesson activities. Teachers report the number of weekly energiser breaks they facilitate, and also report the number of homework tasks assigned, and an estimate of the proportion of children that complete the assigned homework tasks.
Intervention code [1] 331289 0
Lifestyle
Intervention code [2] 331290 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342002 0
Implementation (dose-delivered)
Timepoint [1] 342002 0
6-weeks post commencement of intervention
Primary outcome [2] 342003 0
Implementation (confidence to deliver)
Timepoint [2] 342003 0
6-weeks post commencement of intervention
Primary outcome [3] 342004 0
Implementation (perceived barriers)
Timepoint [3] 342004 0
6-weeks post commencement of intervention
Secondary outcome [1] 449274 0
Acceptability (satisfaction - Teacher); THIS IS A PRIMARY OUTCOME
Timepoint [1] 449274 0
6-weeks post commencement of intervention
Secondary outcome [2] 449275 0
Acceptability (satisfaction - student); THIS IS A PRIMARY OUTCOME
Timepoint [2] 449275 0
6-weeks post commencement of intervention
Secondary outcome [3] 449276 0
Acceptability (future intentions to deliver - teacher); THIS IS A PRIMARY OUTCOME
Timepoint [3] 449276 0
6-weeks post commencement of intervention
Secondary outcome [4] 449277 0
Acceptability (perceived benefits - Teacher); THIS IS A PRIMARY OUTCOME
Timepoint [4] 449277 0
6-weeks post commencement of intervention
Secondary outcome [5] 449278 0
Adaptation; THIS IS A PRIMARY OUTCOME
Timepoint [5] 449278 0
6-weeks post commencement of intervention
Secondary outcome [6] 449279 0
Practicality (use of resources - teacher); THIS IS A PRIMARY OUTCOME
Timepoint [6] 449279 0
6-weeks post commencement of intervention
Secondary outcome [7] 449280 0
Practicality (perceived quality of resources - teacher); THIS IS A PRIMARY OUTCOME
Timepoint [7] 449280 0
6-weeks post commencement of intervention
Secondary outcome [8] 449281 0
Practicality (perceived suitability of school facilities - teacher); THIS IS A PRIMARY OUTCOME
Timepoint [8] 449281 0
6-weeks post commencement of intervention
Secondary outcome [9] 449282 0
Upper body muscular endurance
Timepoint [9] 449282 0
Baseline, 6-weeks post commencement of intervention
Secondary outcome [10] 449283 0
Lower body strength/power
Timepoint [10] 449283 0
Baseline, 6-weeks post commencement of intervention
Secondary outcome [11] 449284 0
Perceived strength
Timepoint [11] 449284 0
Baseline, 6-weeks post commencement of intervention
Secondary outcome [12] 449285 0
Confidence to teach muscle-strengthening activity
Timepoint [12] 449285 0
Baseline, 6-weeks post commencement of intervention
Secondary outcome [13] 449286 0
Perceived barriers to teaching muscle-strengthening activities
Timepoint [13] 449286 0
Baseline, 6-weeks post commencement of intervention

Eligibility
Key inclusion criteria
Teachers: Generalist classroom teacher of stage 2 (grade 3-4) students at a primary school

Children: Students in stage 2 (grade 3-4) of the class of an enrolled teacher
Minimum age
9 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with an injury or condition that would preclude their safe participation in foundational muscle-strengthening physical activities.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics (feasibility measures) and paired-samples t-test (preliminary efficacy measures)

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
28/10/2022
Date of last participant enrolment
Anticipated
Actual
7/11/2022
Date of last data collection
Anticipated
Actual
21/12/2022
Sample size
Target
80
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319228 0
Charities/Societies/Foundations
Name [1] 319228 0
National Heart Foundation of Australia
Country [1] 319228 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 321698 0
None
Name [1] 321698 0
Address [1] 321698 0
Country [1] 321698 0
Other collaborator category [1] 283550 0
University
Name [1] 283550 0
The University of Western Sydney
Address [1] 283550 0
Country [1] 283550 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317807 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 317807 0
Ethics committee country [1] 317807 0
Australia
Date submitted for ethics approval [1] 317807 0
18/08/2022
Approval date [1] 317807 0
19/10/2022
Ethics approval number [1] 317807 0
H-2022-0273
Ethics committee name [2] 317809 0
The Catholic Schools Office of the Diocese of Maitland-Newcastle
Ethics committee address [2] 317809 0
Ethics committee country [2] 317809 0
Australia
Date submitted for ethics approval [2] 317809 0
04/10/2022
Approval date [2] 317809 0
21/10/2022
Ethics approval number [2] 317809 0

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

Contacts
Principal investigator
Name 142222 0
Dr Jordan Smith
Address 142222 0
University of Newcastle, Room V128 University Drive, Callaghan, New South Wales, 2308
Country 142222 0
Australia
Phone 142222 0
+61249217704
Fax 142222 0
Email 142222 0
[email protected]
Contact person for public queries
Name 142223 0
Dr Jordan Smith
Address 142223 0
University of Newcastle, Room V128 University Drive, Callaghan, New South Wales, 2308
Country 142223 0
Australia
Phone 142223 0
+61249217704
Fax 142223 0
Email 142223 0
[email protected]
Contact person for scientific queries
Name 142224 0
Dr Jordan Smith
Address 142224 0
University of Newcastle, Room V128 University Drive, Callaghan, New South Wales, 2308
Country 142224 0
Australia
Phone 142224 0
+61249217704
Fax 142224 0
Email 142224 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    BC04 Expedited Approval.pdf
Ethical approval    Approval Letter UoN Jordan Smith October 2022.pdf
Informed consent form    Parent/carer Parent information statement and consent form_FINAL.pdf
Informed consent form    Teacher Teacher information statement and consent form_FINAL.pdf
Study protocol    Project description.docx


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleNo Pre-print Muscle Movers feasibility paper_FOR ANZCTR.docx

Documents added automatically
No additional documents have been identified.