Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000045516
Ethics application status
Approved
Date submitted
24/11/2023
Date registered
18/01/2024
Date last updated
18/01/2024
Date data sharing statement initially provided
18/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The potential effectiveness of a school-based physical activity program on primary school children's physical activtiy levels in Rabat, Morocco.
Scientific title
The feasibility, acceptability and potential efficacy of a physical activity intervention with a professional development component on primary school students’ physical activity, movement skill and self-perceived physical literacy outcomes in Rabat, Morocco: A Randomised Control Trial
Secondary ID [1] 310943 0
Nil known
Universal Trial Number (UTN)
U1111-1300-3053
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 332014 0
Condition category
Condition code
Public Health 328751 328751 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: A physical activity games manual, complimented with teacher professional development focused on delivering physical activity games during class time.
WHY: Primary school children in Morocco do not currently benefit from sufficient levels of physical activity at school, this is partly due to a lack of professional development for teachers.
WHAT: Teachers will be provided with an evidence-based physical activity games manual and professional development program developed for this study. The program has been developed to improve student physical activity levels in addition to movement skill and physical literacy outcomes. Teachers will be responsible for delivering the intervention to students during class time for 20 minutes, 3 times a week for 12 weeks. Games are focused on different skills eg. throwing, locomotion, kicking etc., examples include the commonly known game 'rob the nest', variations of relays and small-sided soccer and netball games. Intervention school teachers will be provided with the physical activity equipment needed to implement the games from the manual. A Professor with expertise in physical activity coaching will be responsible for delivering the professional development utilising a hybrid approach. Teachers will participate in 3 x 1 hour face to face sessions, 3 short reflection sessions following SOFIT observations and will engage in an online forum throughout the intervention period.
The study will involve three arms:
Arm 1: Control group
Arm 2: Intervention group 1 (receives the physical activity games manual)
Arm 3: Intervention group 2 (receives the physical activity games manual in addition to professional development)
Fidelity will be assessed using activity logs for the 12 weeks and observations conducted using the system for observing fitness instruction time (SOFIT) at three time points. The SOFIT observations will be conducted by the Ministry’s inspectors who are responsible for regularly attending schools to assess teacher practice.
Intervention code [1] 327388 0
Behaviour
Intervention code [2] 327389 0
Lifestyle
Comparator / control treatment
The control group will continue with their usual daily practices at school during the intervention period and will act as a wait-list control. The control group will be provided with all components of the intervention in the following school year beginning October 2024.
Control group
Active

Outcomes
Primary outcome [1] 336574 0
Physical activity levels
Timepoint [1] 336574 0
The monitors will be worn for 7 complete, consecutive days, at baseline and again at follow up (immediately after 12 weeks of intervention).
Secondary outcome [1] 428837 0
Fundamental movement skills
Timepoint [1] 428837 0
Baseline and follow up (immediately after 12 weeks of intervention)
Secondary outcome [2] 428838 0
Self-perceived physical literacy
Timepoint [2] 428838 0
Baseline and follow up (immediately after 12 weeks of intervention), test-retest assessments of the questionnaire from the Canadian Assessment of Physical Literacy version 2 will also be conducted at baseline.
Secondary outcome [3] 430258 0
Feasibility (process measure)
Timepoint [3] 430258 0
Follow up, immediately after 12 weeks of intervention.
Secondary outcome [4] 430259 0
Fidelity (process measure)
Timepoint [4] 430259 0
- SOFIT: At 3 points throughout the intervention period (4-, 8- and 12-weeks post-commencement of the intervention),
- Teacher logs: Throughout the 12 weeks of intervention teachers must log all activity that they do with their class
Secondary outcome [5] 430748 0
Acceptability (process measure)
Timepoint [5] 430748 0
- Focus groups: Follow up, immediately after 12 weeks of intervention
- Teacher logs: Throughout the 12 weeks of intervention teachers must log all activity that they do with their class

Eligibility
Key inclusion criteria
Primary school students in grade 5 or 6 (ages 9-13) in Rabat, Morocco
Minimum age
9 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Primary school students that are not in grade 5 or 6 (aged 9-13 years) at one of the schools selected for the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools will not be randomised until after baseline data collection. An off-site administrative representative will randomly allocate each school to one of the three arms.
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
Pilot studies are not adequately powered to detect statistically significant differences between groups. Therefore, a sample-size calculation is not appropriate for this study.
Quantitative analysis
Statistical analyses will be performed using R studio. Statistical procedures will include descriptive analysis, t-test, analysis of variance (ANOVA), correlations, and general linear model regression analyses. Analyses of outcome measures included will be adjusted for common confounders: age at time of testing, gender, class level clustering and accelerometry wear time. Standardised mean differences (SMD), or effect sizes (Cohen, 1988), will be calculated as a change measured in the intervention schools relative to the control schools as a proportion of the pooled standard deviation of the change. An SMD of 0.2–0.5 is considered to be small, an SMD of 0.5–0.8 is considered to be medium and an SMD of 0.8 or above is considered to be large (Cohen, 1992). The Statistical Consulting Service at UOW will be utilised once the data has been collected, to ensure that the appropriate analyses are performed.
Teacher and Student Focus Groups
Digital audio files from each focus group will be transcribed verbatim and translated to English for analysis in consultation with researchers in Morocco. Data analysis will follow the guidelines for thematic analysis outlined by Braun and Clarke (2006). To enhance trustworthiness of the analysis a “critical friend”, a colleague who is not involved in the project, will provide feedback on the process of the analysis (Braun and Clarke, 2006). The Chief investigator in Morocco and the doctoral student will read and/or listen to the audio recording to become familiarised with the data. Each transcript will then be coded thematically; this is an open coding process, whereby meaningful quotes or key examples from educators and students will be assigned a code. These “emergent” codes will then be grouped together to develop themes (Braun and Clarke, 2006). Once themes are developed, the second and third author provides critical feedback on the analysis and interpretations of the study. The peer debrief is concerned with the ongoing process of data collection and analysis. This process will take place through regular meetings with the research team.
Demographic characteristics
Demographic characteristics (ie., age and gender), collected through the questionnaire will be tabulated and compared using descriptive statistics. Categorical variables will be summarised using total numbers and percentages. Continuous variables will be summarised using mean and standard deviation for normally distributed data, or median and interquartile range for data that are not normally distributed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment outside Australia
Country [1] 25983 0
Morocco
State/province [1] 25983 0

Funding & Sponsors
Funding source category [1] 315204 0
Government body
Name [1] 315204 0
Ministry of National Education, Preschool and Sports, Kingdom of Morocco
Country [1] 315204 0
Morocco
Funding source category [2] 315226 0
Government body
Name [2] 315226 0
National Health and Medical Research Council Investigators Grant
Country [2] 315226 0
Australia
Primary sponsor type
University
Name
University of Wollongong, Australia
Address
Northfields Ave, Wollongong NSW 2522, Australia
Country
Australia
Secondary sponsor category [1] 317228 0
Government body
Name [1] 317228 0
Ministry of National Education, Preschool and Sports, Morocco
Address [1] 317228 0
Annexe lalla Aicha Avenue Chellah MA - 10000 Rabat, Morocco
Country [1] 317228 0
Morocco
Other collaborator category [1] 282878 0
Individual
Name [1] 282878 0
Dr Asmaa EL Hamdouchi
Address [1] 282878 0
Unité de recherche en nutrition et alimentation (UNA) CNESTEN.BP 1382 RP. 10001 RABAT . MAROC.
Country [1] 282878 0
Morocco

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314129 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 314129 0
Northfields Ave Wollongong, NSW 2522 Australia
Ethics committee country [1] 314129 0
Australia
Date submitted for ethics approval [1] 314129 0
02/02/2023
Approval date [1] 314129 0
07/03/2023
Ethics approval number [1] 314129 0
2023/022

Summary
Brief summary
Primary school children in Morocco do not currently benefit from sufficient physical activity during class time. The purpose of this study is to trial a physical activity games manual intervention, including professional development for teachers, and to examine the feasibility, acceptability and potential efficacy of the intervention on primary school children's physical activity levels in Morocco. Movement skills and self-percevied physical literacy will also be assessed as secondary outcomes.
Trial website
Trial related presentations / publications
Public notes
The study has approval from the Ministry of National Education, Preschool and Sports in Morocco and will also be submitted to the Ethics Committee for Biomedical Research, Rabat, Morocco.

Contacts
Principal investigator
Name 130514 0
Prof Anthony Okely
Address 130514 0
University of Wollongong, Northfields Ave, Wollongong NSW 2522, Australia
Country 130514 0
Australia
Phone 130514 0
+61 425227616
Fax 130514 0
Email 130514 0
tokely@uow.edu.au
Contact person for public queries
Name 130515 0
Miss Kayla Elliott
Address 130515 0
University of Wollongong, Northfields Ave, Wollongong NSW 2522, Australia
Country 130515 0
Australia
Phone 130515 0
+61 421211527
Fax 130515 0
Email 130515 0
ke588@uowmail.edu.au
Contact person for scientific queries
Name 130516 0
Miss Kayla Elliott
Address 130516 0
University of Wollongong, Northfields Ave, Wollongong NSW 2522, Australia
Country 130516 0
Australia
Phone 130516 0
+61 421211527
Fax 130516 0
Email 130516 0
ke588@uowmail.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.