Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000035426p
Ethics application status
Submitted, not yet approved
Date submitted
4/12/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Strength in Numbers: A classroom based resistance training and mathematics intervention
Scientific title
Feasibility of a classroom based resistance training and mathematics intervention: Protocol and preliminary findings from the Strength in Numbers Pilot Study
Secondary ID [1] 313519 0
Nil known
Universal Trial Number (UTN)
U1111-1316-4841
Trial acronym
SIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maths anxiety 335955 0
Attention 335956 0
Condition category
Condition code
Mental Health 332544 332544 0 0
Anxiety
Mental Health 332545 332545 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Brief name: Strength in Numbers

2. What materials: The materials for the Strength in Numbers program include a series of eight 5-minute videos, designed to be delivered at the beginning of each mathematics lesson. These videos will integrate resistance training exercises with mathematics content, providing short, focused movement breaks that align with the curriculum.

3. What procedures: Access to the Intervention videos will be available to classroom teachers via email after the completion of baseline measures. Teachers will then deliver the video intervention at the beginning of the lesson to their Stage 5 mathematics class on two occasions throughout the week. The procedure that will be followed in the classroom is that teachers will:
- Allow students to enter the classroom with your regular procedure
- Ask students to place their bag away from their chair or under their desk
- No equipment, especially laptops should be removed from the student’s bag.
- Students stand behind their desk, with their chair behind them.
- Once all students are ready, play the Strength in Numbers video. The video lasts 5 minutes. During the video could you please encourage participation and ensure students perform exercises safely within their own desk area. You may also participate as this often encourages class participation.
- Record each completed session to monitor adherence to the program.

4. Who provided: The materials for the Strength in Numbers program are provided online as a video to increase consistency across classes. Each classroom teacher will play the video, and they are encouraged to use suggested strategies to promote student participation. The video prescribes body weight exercises such as lunges, chair tricep dips and isometric contractions.

5. How: Stage 5 Mathematics classes occur 2-3 times per week. Teachers can select the most suitable lessons to deliver the intervention but this must occur at least twice during the week.

6. Where: Participants will complete the intervention while at their own desk in the mathematics classroom.

7. When and how much: The Strength in Numbers videos are 5 minutes long. They are designed using a Tabata protocol (20 seconds exercising and 10 seconds break, Total = 4 minutes). At the completion of the exercise there is 1 minute to complete a numeracy question, relating to the topic as a class. The video will be delivered 2 x per week for 4 weeks (Total sessions = 8). The intensity of the sessions are designed to be moderate.

8. Tailoring: All participants will take part in the Strength in Numbers program. The introduction video advises students to modify exercises if they can't do them because of an injury or their surroundings. For example, if someone has an arm injury, they can do squats instead of chair tricep dips. Each exercise has different difficulty levels, and participants are encouraged to try the highest level they feel comfortable with.
Intervention code [1] 330095 0
Treatment: Other
Comparator / control treatment
No control group for Phase 1
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340066 0
Examine the feasibility of the Strength in Numbers intervention. This will be assessed as a composite outcome
Assessment method [1] 340066 0
Focus group discussions Trained research assistants will conduct focus groups. The focus group is designed to assess participants' current thoughts and feelings about the Strength in Numbers intervention that they have been participating in over the past four weeks. Students who provided consent will be randomly selected to participate (n=2 per class, total n=4). The focus group discussion will take no more than 30 minutes. The focus group is semi structured and includes questions relating to three categories: 1. Research design E.g., How did you feel about the structure of the SiN program (4 weeks, 2 videos per week)? 2. Intervention Fidelity E.g., Did you find the resistance training exercises easy to complete in the classroom? 3. Acceptability E.g., How often would you choose to start your mathematics lessons with a SiN video? Privacy will be maintained by removing names during the interview and recordings will be stored securely at completion. Transcriber AI will be used to convert audio to text. This program prioritizes your privacy with stringent security measures, encrypting all stored files and transcriptions, accessible only to the Chief Investigator. Interviews Trained research assistants will conduct interviews. The interview is designed to assess only the teachers thoughts and feelings about the Strength in Numbers intervention that they have been delivering over the past four weeks. The discussion will take no more than 15 minutes. The interview is semi structured and includes questions relating to three categories: 1. Research design E.g., How did you find the overall structure of the program (4 weeks, 2 videos per week)? 2. Intervention Fidelity E.g., How easy was it for students to follow the resistance training exercises in the classroom setting? 3. Acceptability E.g., Do you think you would continue using this program or a similar one in your classroom? Privacy will be maintained by removing names during the interview and recordings will be stored securely at completion. Transcriber AI will be used to convert audio to text. This program prioritizes your privacy with stringent security measures, encrypting all stored files and transcriptions, accessible only to the Chief Investigator. Survey To evaluate the Capability, Opportunity and Motivation to deliver the Strength in Numbers program we will use a validated survey designed by Verdonschot et al., (2024). This survey sues the COM-PASS approach. The questions will be moved to Question Pro after ethics approval and delivered to participating teachers via email.
Timepoint [1] 340066 0
Post-completion of 8-session program
Secondary outcome [1] 442523 0
Evaluate the preliminary efficacy of the Strength in Numbers program on Stage 5 mathematics students' Acute Maths anxiety
Assessment method [1] 442523 0
To assess Acute Maths Anxiety participants will complete the the Maths Anxiety Survey adapted from: Ersozlu, Z. (2024). The Acute Math Anxiety Scale (AMAS): Psychometric Properties and Applications for Immediate Anxiety Assessment. [Unpublished Manuscript]. This measure that includes 6 questions assessing Maths anxiety and will be completed before and after each Strength in Numbers session. This will be completed on an online survey platform which participants will access on their personal devices. Three questions must be answered before you do the program and three questions after you finish. 1. How are you feeling BEFORE the maths lesson? Nervous, Okay, Excited 2. Rate your readiness for learning BEFORE doing the Strength in Numbers Program. Not ready, a little ready, ready, very ready. 3. Rate your confidence level BEFORE doing the Strength in Numbers Program. Not confident, a little confident, confident, very confident. PERFORM THE STRENGTH IN NUMBERS EXERCISE PROGRAM 4. How are you feeling AFTER the maths lesson? Nervous, Okay, Excited 5. Rate your readiness for learning AFTER doing the Strength in Numbers Program. Not ready, a little ready, ready, very ready. 6. Rate your confidence level AFTER doing the Strength in Numbers Program. Not confident, a little confident, confident, very confident.
Timepoint [1] 442523 0
Acute Maths Anxiety will be measured before and after each session.
Secondary outcome [2] 442524 0
Evaluate the preliminary efficacy of the Strength in Numbers program on Stage 5 mathematics students On-Task behaviour.
Assessment method [2] 442524 0
A measure of On-Task behaviour will be conducted on 12 students in the class after completing each of the Strength in Numbers sessions. On Task Behaviour assessment tool is adapted from: Alberto.P and Troutman.A (2003) Applied Behaviour Analysis for Teachers-6th edition, Pearson Education, Australia. Two researchers to enter the room and select 6 CONSENTING students each to assess (Total = 12). Collect the names of these students from the demographic survey. Agree on a start time. Begin timers together and track student behaviour over a 30 minute time frame. At intervals indicated on the Momentary time sampling sheets researchers will use the following codes to determine activity: AE = Actively engaged Answering questions, completing set tasks, discussing class content with peers PE = Passively engaged Listing to teacher instructions, listening to peers instructions OM = Off task motor Out of seat, distracted by equipment around them, drawing off task, phone use. OV = Off Task Verbal Non subject specific discussion with peers or teacher. OP= Off task passive At the completion of the 30 minutes researchers can leave the room without interruption.
Timepoint [2] 442524 0
This acute measure is completed at the end of each participation in the intervention.
Secondary outcome [3] 443583 0
Evaluate the preliminary efficacy of the Strength in Numbers program on Stage 5 mathematics students' Chronic Maths anxiety
Assessment method [3] 443583 0
Chronic Maths Anxiety will be assessed using the The Math Anxiety Scale: Adapted from Betz, N. E. (1978). The survey will be provided to students prior to the start of the Strength in Numbers program. Consenting students will complete the 10 questions in class. The questions will be provided as hard copies under the supervision of a trained research assistant. The questions are below and answers are provided on a 1,2,3,4,5 likert scale: 1. It wouldn't bother me at all to take more maths classes. 2. I have usually been at ease during maths tests. 3. I have usually been at ease in maths courses. 4. I usually don't worry about my ability to solve maths problems. 5. I almost never get uptight while taking maths tests. 6. I get really uptight during maths tests. 7. I get a sinking feeling when I think of trying hard maths problems. 8. My mind goes blank, and I am unable to think clearly when working on mathematics. 9. Mathematics makes me feel uncomfortable and nervous 10. Mathematics makes me feel uneasy and confused.
Timepoint [3] 443583 0
Chronic Maths Anxiety will be measured before the start of the program and at the completion of the 8 sessions.

Eligibility
Key inclusion criteria
Typically developing Year 9 and 10 High school students studying mathematics.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with severe learning disabilities.

Study design
Purpose of the study
Treatment
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
Data analysis

In this feasibility study, data analysis will concentrate on evaluating the Strength in Numbers program's feasibility. Analysis will be conducted using research software including SPSS, R data and NVivo. Each measure is aligned with the project's objectives and will be analysed using the techniques mention in the next section.

i) Examine the feasibility of the Strength in Numbers intervention
Analysis of recruitment data will be mainly descriptive (means and SD, median and 25th to 75th centiles for non-normal distributions, or N and %) as appropriate. Loss to post test will be reported. Interviews and focus groups will be analysed using computer software NVivo v12. Thematic analysis will be used to analyse all focus groups and interviews. Triangulation of the survey data will be used to combine qualitative and quantitative data analysis.

ii) Evaluate the preliminary efficacy of the Strength in Numbers program on Stage 5 mathematics students Maths anxiety and On-Task behaviour.
Demographic characteristics will be summarized descriptively. Categorical data will be reported as frequency counts, while continuous data will be expressed as means and standard deviations. For the self-perception of mathematics, the responses will be categorized into groups (e.g., low, medium, high self-perception) for further analysis. On Task behaviour final scores will be reported as percentages of time spent on-task or off-task. Repeated measures ANOVA will be used to assess significant differences in on-task behaviour across recorded time points. Additionally, a correlation analysis will explore the relationship between on-task behaviour scores and self-perception of mathematics. Scores from the Maths Anxiety Measure 1 will be totalled. A paired samples t test will be conducted to compare the means between the two time points. Pre and post exercise scores from the Maths Anxiety 2 measure will be assessed using a repeated measures ANOVA. Additionally, a correlation analysis will explore the relationship between maths anxiety scores and self-perception of mathematics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 43468 0
2308 - Callaghan
Recruitment postcode(s) [2] 43469 0
2320 - Maitland
Recruitment postcode(s) [3] 43470 0
2289 - Adamstown Heights

Funding & Sponsors
Funding source category [1] 317970 0
University
Name [1] 317970 0
University of Newcastle
Country [1] 317970 0
Australia
Primary sponsor type
University
Name
Univeristy of Newcastle
Country
Australia
Secondary sponsor category [1] 320311 0
None
Name [1] 320311 0
Country [1] 320311 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316640 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 316640 0
Ethics committee country [1] 316640 0
Australia
Date submitted for ethics approval [1] 316640 0
03/12/2024
Approval date [1] 316640 0
Ethics approval number [1] 316640 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138506 0
Dr Katie Robinson
Address 138506 0
V125, Callaghan Campus, University of Newcastle, NSW, 2308
Country 138506 0
Australia
Phone 138506 0
+61 412578572
Email 138506 0
katie.robinson@newcastle.edu.au
Contact person for public queries
Name 138507 0
Katie Robinson
Address 138507 0
V125, Callaghan Campus, University of Newcastle, NSW, 2308
Country 138507 0
Australia
Phone 138507 0
+61 412578572
Email 138507 0
katie.robinson@newcastle.edu.au
Contact person for scientific queries
Name 138508 0
Katie Robinson
Address 138508 0
V125, Callaghan Campus, University of Newcastle, NSW, 2308
Country 138508 0
Australia
Phone 138508 0
+61 412578572
Email 138508 0
katie.robinson@newcastle.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Feasibility data will not be made public due to the inherent possibility that even though data is unidentified participants may be able to be identified through other means.



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24383Study protocol    V1_Research Protocol Strength in Numbers 2024.pdf



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.