Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000642088
Ethics application status
Approved
Date submitted
2/08/2010
Date registered
9/08/2010
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Fit 4 Fun Program: Promoting physical fitness and health in primary school children.
Scientific title
Effects of a school-based physical fitness intervention on physical activity behaviours, physical fitness levels and attitudes towards physical fitness in primary school children.
Secondary ID [1] 252358 0
Nil
Universal Trial Number (UTN)
Trial acronym
Fit 4 Fun
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical fitness in primary school children 257870 0
Physical activity in primary school children 257871 0
Condition category
Condition code
Public Health 258031 258031 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘Fit 4 Fun’ Program is an 8-week comprehensive school-based health-related fitness program designed for Stage 3 primary school students. Its effectiveness and suitability for use in primary schools will be evaluated through a Randomized Control Trial (RCT) feasibility study in two primary schools. The ‘Fit 4 Fun’ program will take a multi-faceted approach to physical fitness education by involving students, staff, parents and family members in a range of fun and challenging activities designed to increase knowledge, skills and attitudes regarding physical fitness and health. The Fit 4 Fun Program was developed in accordance to the NSW Personal Development, Health & Physical Education (PDHPE) K-6 curriculum and is grounded in Bandura's Social Cognitive Theory and Harter's Competence Motivation theory. The program facilitates behaviour change by targeting the following mediators of change: self-efficacy, social support, self-monitoring and enjoyment. The Fit 4 Fun program focuses on the three areas of a 'Health Promoting School' by having programs that combine to improve the physical fitness behaviours and attitudes of children and their families. They are:- 1) Home: the children complete an 8 week home activity program with their parents and siblings & / or friends. The program is completed 4 times for week and not only engages the participants in a range of innovative fitness-based activities and games but also provides activities specifically designed to enhance skills is self-evaluation, physical fitness assessment and goal-setting. The children are provided with a home activity booklet and access to equipment. 2) Curriculum: the students participate in 8 weekly PDHPE lessons (60min) that are specifically designed to improve knowledge, skills, understanding and appreciation of the role that physical fitness and fitness assessment plays in improving health. The lessons combine theoretical and practical learning experiences across the 4 health-related fitness components (flexibility, muscular fitness, body composition and cardio-respiratory fitness). The teachers and students are provided with work booklets, all resources and learning materials. 3) School Environment: during recess and lunch breaks, children are encouraged to participate in a wide range of fun activities, small-sided games and fitness challenges to not only get the children physically active but to improve their physical fitness levels. The children are provided with game cards and equipment, and are encouraged to be self-motivated & directed during their break times.
Intervention code [1] 256920 0
Behaviour
Intervention code [2] 256921 0
Prevention
Comparator / control treatment
Wait list control. Schools in the control group will receive the intervention at the completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 258880 0
Health-Related Physical Fitness 1) Cardiorespiratory fitness will be assessed using the 20m shuttle test (beep test) 2) Muscular fitness will be assessed using the 7-stage sit-up test, the Basketball Throw test, Cadence Push-Up test and Wall Squat Test. 3) Flexibility will be assessed using the Sit & Reach test and the Shoulder Stretch test. 4) Body Composition will calculated using measurements from height (stadiometer) and weight (callibrated scales).
Timepoint [1] 258880 0
Baseline and at the completion of the intervention (10 weeks after basline measures).
Secondary outcome [1] 265030 0
1) Physical Activity will be assessed using at least 5 days of pedometery (4 week days and 1 weekend day)
Timepoint [1] 265030 0
Baseline and at the completion of the intervention (10 weeks after basline measures).
Secondary outcome [2] 265031 0
1) Perceptions of physical fitness & fitness testing: using a questionnaire (students & teachers). The questionnaire is a purpose designed survey assessing participants thoughts and feelings about physical fitness and fitness testing. Demographic information will also be collected.
Timepoint [2] 265031 0
Baseline and at the completion of the intervention (10 weeks after basline measures).

Eligibility
Key inclusion criteria
Stage 3 Primary School Children (year 5 & 6).
Minimum age
9 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All students in the Stage 3 class will participate in the program, however, only the students who provide signed consent letters will complete the assessments and evaluations. Students will also be ineligible to be included in the program evaluation if they currently have a medical condition or physical injury preventing testing or training (they will be able to participate in the program).

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)
Two primary schools from the Lake Macquarie Region will be invited to participate in the feasibility study of the Fit 4 Fun Program. a) Initial contact – The school Principals will be contacted by Narelle Eather and invited to participate in the study. The Principals will be provided with an information statement outlining the feasibility study in detail. If the Principal consents to the school’s participation in the study then Narelle Eather will make contact with the Stage 3 teacher to seek permission to conduct the feasibility study with their class. The classroom teacher will also be given an information statement outlining the Fit 4 Fun program and their role during the delivery stage. A consent form will be collected from the participating teacher. b) Recruitment – Once a school has expressed interest in the project and have returned their consent forms, Narelle Eather will contact the school and request an opportunity to present the research proposal to students. Information leaflets will be distributed at a school assembly. All parents and students will be provided with information and consent letters. Once all consent letters have been collected and eligibility determined then baseline assesments will be conducted and randomisation will occur at the school level. Allocation will be concealed and conducted after eligibility has been determined. The allocation of groups will be conducted 'off-site' and the allocation schedule will be announced by the off-site administrator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation method of a coin test will be conducted to allocate schools to either the control or the treatment conditions. This method ensures that all schools will have an equal likelihood of allocation to either the control or intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait list control design. Participants assigned to the control group will receive the intervention at the completion of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
30/04/2010
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
50
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257370 0
Self funded/Unfunded
Name [1] 257370 0
Narelle Eather
Country [1] 257370 0
Australia
Primary sponsor type
Individual
Name
Narelle Eather
Address
Health and Physical Education Building (HPE)
The University of Newcastle
University Drive,
Callaghan, NSW. 2308
Country
Australia
Secondary sponsor category [1] 256610 0
University
Name [1] 256610 0
The University of Newcastle
Address [1] 256610 0
The University of Newcastle
University Drive,
Callaghan, NSW. 2308
Country [1] 256610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259391 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 259391 0
Ethics committee country [1] 259391 0
Australia
Date submitted for ethics approval [1] 259391 0
Approval date [1] 259391 0
28/03/2010
Ethics approval number [1] 259391 0
H-2009-0397

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

Contacts
Principal investigator
Name 31457 0
Dr Narelle Eather
Address 31457 0
HPE 310
University Drive
Callaghan NSW 2308
Country 31457 0
Australia
Phone 31457 0
0425302312
Fax 31457 0
Email 31457 0
narelle.eather@newcastle.edu.au
Contact person for public queries
Name 14704 0
Narelle Eather
Address 14704 0
The University of Newcastle
School of Education
Callaghan Campus,
University Drive,
NSW, 2308.
Country 14704 0
Australia
Phone 14704 0
+61 2 49216232
Fax 14704 0
+61 2 49217407
Email 14704 0
narelle.eather@newcastle.edu.au
Contact person for scientific queries
Name 5632 0
Narelle Eather
Address 5632 0
The University of Newcastle
School of Education
Callaghan Campus,
University Drive,
NSW, 2308.
Country 5632 0
Australia
Phone 5632 0
+61 2 49216232
Fax 5632 0
+61 2 49217407
Email 5632 0
Narelle.eather@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.