Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000562774
Ethics application status
Approved
Date submitted
2/03/2022
Date registered
12/04/2022
Date last updated
6/03/2023
Date data sharing statement initially provided
12/04/2022
Date results information initially provided
6/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Physical Literacy Breaks (PLBreaks) program on physical literacy in Portuguese schoolchildren
Scientific title
Effect of Physical Literacy Breaks (PLBreaks) program on physical literacy in Portuguese schoolchildren
Secondary ID [1] 306566 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical literacy 325465 0
Condition category
Condition code
Public Health 322845 322845 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group will carry out the program in the educational centres during break times, 3 times a week, for 3 months. The duration of each session will be between 20 and 30 minutes, according to the time pre-established by each educational centre for the students' breaks. During these sessions, activities will be carried out in which physical activity is practised at the same time as motivation is fostered and knowledge is acquired about healthy lifestyle habits and knowledge about conceptual aspects of physical activity and its benefits.
Every session will be divided into two 10-minute blocks. In the first block, activities will be carried out to develop knowledge and understanding of healthy lifestyle habits and active daily behaviours through body expression. For example, students in groups will have to represent ways of moving actively to school, a concept related to Physical Activity (strength, endurance, agility...), a healthy lifestyle habit, a sporting skill,... and their classmates will have to guess their actions.
The second block will be based on active play, as play is fundamental in the transmission of values and attitudinal content, also stimulating social and civic relations with others. During the games, basic skills will be developed, such as moving, jumping, spinning or throwing, thus trying to improve them, as well as the motivation of the pupils. The games will have a cooperative as well as a competitive component, due to the motivational benefits this can bring. All session will be supervised by the physical education teacher and a sports sciences professional researcher. The attendance will be checked using a checklist.
Intervention code [1] 322999 0
Treatment: Other
Comparator / control treatment
The control group will continue with their usual teaching activities, which involve spending allocated breaks outside, with no structured physical activity or play.
Control group
Active

Outcomes
Primary outcome [1] 330629 0
Physical literacy assessed using the Canadian Assessment of Physical Literacy Development (CAPL-2).
Timepoint [1] 330629 0
Prior to start the intervention (week 0), upon completion of the intervention (week 13, primary timepoint) and one month after the end of the intervention (week 17) as follow up measure.
Secondary outcome [1] 407045 0
Bodyweight shall be measured with a bioimpedance meter (Tanita MC-780 MA, Tanita Corporation, Tokyo, Japan). The assessment shall be performed in 'standard mode' by entering the participant's age, sex and height. The body weight will be recorded in kg, with an accuracy of 100 g. This instrument will also be used to assess participants' fat mass, fat mass percentage and fat-free mass. In addition, to obtain accurate measurements from the bioimpedance meter, preconditions will be standardised according to the manufacturer's guidelines: more than 3 hours after waking up, urinating before the measurement, not eating or drinking within the last 3 hours, not eating or drinking excessively the previous day, no heavy exercise within the last 12 hours, no alcohol consumption within the last 12 hours, and no use of metal objects or wearing a pacemaker.
Timepoint [1] 407045 0
Prior to start the intervention (week 0), upon completion of the intervention (week 13) and one month after the end of the intervention (week 17) as follow up measure.
Secondary outcome [2] 407757 0
Height shall be measured with a measuring rod (Tanita Tantois, Tanita Corporation, Tokyo, Japan). The instrument shall be placed on a vertical surface where the measuring scale shall be perpendicular to the ground. The height shall be measured while standing, with the shoulders balanced and the arms relaxed along the body. The measurement shall be made in cm, to the nearest mm.
Timepoint [2] 407757 0
Prior to start the intervention (week 0), upon completion of the intervention (week 13) and one month after the end of the intervention (week 17) as follow up measure.

Eligibility
Key inclusion criteria
Participants must meet the following inclusion criteria: (1) age between 8 and 16 years; (2) be registered and/or residing in Portugal; (3) not suffer from pathologies that contraindicate the exercise and physical activity programme or require special attention; (4) authorised by parents or legal guardians; and (5) acceptance of the child or young person to participate in the study.
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Simple randomisation using a randomisation table created by computer software. Participants will be randomly assigned to the experimental or control groups. Prior to enrolling participants (1:1) the Research Randomizer software (version 4.0, Geoffrey C. Urbaniak and Scott Plous, Middletown, CT, USA; http://www.randomizer.org) will be used in order to create a randomization sequence. A member of the research team with no active clinical involvement in the trial will conduct this process. Group assignment will be hidden in a password-protected computer file.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2022
Actual
16/01/2023
Date of last participant enrolment
Anticipated
Actual
31/01/2023
Date of last data collection
Anticipated
Actual
23/02/2023
Sample size
Target
128
Accrual to date
Final
128
Recruitment outside Australia
Country [1] 24628 0
Portugal
State/province [1] 24628 0

Funding & Sponsors
Funding source category [1] 310899 0
Government body
Name [1] 310899 0
Government of Spain; Ministry of Universities
Country [1] 310899 0
Spain
Funding source category [2] 310900 0
University
Name [2] 310900 0
Universidad de Extremadura
Country [2] 310900 0
Spain
Primary sponsor type
University
Name
Universidad de Extremadura
Address
Avda. de Elvas, s/n 06006, Badajoz
Country
Spain
Secondary sponsor category [1] 312185 0
None
Name [1] 312185 0
Address [1] 312185 0
Country [1] 312185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310462 0
Comissão de Ética da Universidade de Évora (CÉ-UÉ)
Ethics committee address [1] 310462 0
Largo dos Colegiais 2, 7004-516 Évora, Portugal
Ethics committee country [1] 310462 0
Portugal
Date submitted for ethics approval [1] 310462 0
21/03/2022
Approval date [1] 310462 0
31/03/2022
Ethics approval number [1] 310462 0
22047

Summary
Brief summary
Few studies have investigated the association between physical literacy and health. Therefore, the objectives of this project are to assess the level of physical literacy in schoolchildren and adolescents, to identify the domains with the greatest deficiencies, and to guide the intervention according to them and improve physical literacy, and therefore physical inactivity, as well as body composition after a programme of active breaks, through physical activity. A randomised controlled trial with a 3-month intervention phase will be conducted in school children and adolescents aged 8-16 years. Anthropometric and body composition measurements will be carried out and physical literacy will be assessed using the Canadian Assessment of Physical Literacy (CAPL-2). The intervention will consist of activities in which physical activity is practised while fostering motivation and acquiring knowledge about healthy lifestyle habits and knowledge about conceptual aspects of physical activity and its benefits. They will be carried out 3 times a week (30 min), in the participants' break periods of the school day.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117746 0
Dr María Mendoza-Muñoz
Address 117746 0
Facultad de Ciencias del Deporte, Universidad de Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres
Country 117746 0
Spain
Phone 117746 0
+34 927 25 74 60
Fax 117746 0
Email 117746 0
mamendozam@unex.es
Contact person for public queries
Name 117747 0
Dr María Mendoza-Muñoz
Address 117747 0
Facultad de Ciencias del Deporte, Universidad de Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres
Country 117747 0
Spain
Phone 117747 0
+34 927 25 74 60
Fax 117747 0
Email 117747 0
mamendozam@unex.es
Contact person for scientific queries
Name 117748 0
Dr María Mendoza-Muñoz
Address 117748 0
Facultad de Ciencias del Deporte, Universidad de Extremadura, Avenida de la Universidad, s/n, 10003 Cáceres
Country 117748 0
Spain
Phone 117748 0
+34 927 25 74 60
Fax 117748 0
Email 117748 0
mamendozam@unex.es

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.