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Trial registered on ANZCTR
Registration number
ACTRN12611000976987
Ethics application status
Approved
Date submitted
11/09/2011
Date registered
13/09/2011
Date last updated
15/11/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Fit 4 Fun Program: Promoting physical fitness and health in primary school children (phase 2)
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Scientific title
Effects of a school-based physical fitness intervention (Fit 4 Fun) on physical activity behaviours, physical fitness levels and attitudes towards physical fitness in primary school children (phase 2).
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Secondary ID [1]
263023
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Phase 1 of this trial was registered on the ANZCTR, Registration ID: ACTRN12610000642088
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Universal Trial Number (UTN)
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Trial acronym
Fit 4 Fun
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Physical fitness in primary school children
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Physical activity in primary school children
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Condition category
Condition code
Public Health
270926
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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) in four 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.
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Intervention code [1]
269364
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Behaviour
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Intervention code [2]
269365
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Prevention
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Comparator / control treatment
Wait list control. Schools in the control group will receive the intervention at the completion of the study.
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Control group
Active
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Outcomes
Primary outcome [1]
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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 STanding Jump. 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).
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Assessment method [1]
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Timepoint [1]
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Baseline, immediate post-intervention (10 weeks after basline measures) and 6-month follow-up.
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Secondary outcome [1]
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1) Physical Activity will be assessed using at least 4 days of pedometery (3 week days and 1 weekend day)
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Assessment method [1]
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Timepoint [1]
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Baseline, immediate post-intervention (10 weeks after basline measures) and 6-month follow-up.
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Secondary outcome [2]
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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.
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Assessment method [2]
294006
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Timepoint [2]
294006
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Baseline, immediate post-intervention (10 weeks after basline measures) and 6-month follow-up.
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Eligibility
Key inclusion criteria
Stage 3 Primary School Children (year 5 & 6).
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Minimum age
9
Years
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Maximum age
13
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Four primary schools will be invited to particpate in phase 2 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 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 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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple comuterised algorithm allocation 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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
Control received all resources and intervention materials
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/04/2011
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
30/04/2011
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Date of last data collection
Anticipated
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Actual
20/12/2012
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Sample size
Target
200
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Narelle Eather
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Address [1]
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Health and Physical Education Building (HPE)
The University of Newcastle
University Drive,
Callaghan, NSW. 2308
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Newcastle
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Address
The University of Newcastle
University Drive,
Callaghan, NSW. 2308
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Country
Australia
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Secondary sponsor category [1]
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Other
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Name [1]
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Sports Medicine Australia
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Address [1]
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New South Wales
PO Box 3176
RHODES NSW 2138
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
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Callaghan Campus,
University Drive, Callaghan, NSW, 2308.
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
271792
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Approval date [1]
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28/03/2010
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Ethics approval number [1]
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H-2009-0397
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Summary
Brief summary
The aim of this research project (RCT) is to evaluate the impact of a school-based health-related fitness intervention (Fit 4 Fun) on the fitness and activity levels, and attitudes towards physical fitness, of Stage 3 primary school students. The study will assess changes over 10 weeks and 6-months. Phase 1 of the study evaluated the preliminary feasibility and efficacy of the program for use in primary schools. This phase of the study (Phase 2) will evaluate the feasibility and efficacy of the program using a larger sample group.
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Trial website
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Trial related presentations / publications
17. Eather, N., Morgan, P. J., & Lubans, D. R. (2013). Feasibility and preliminary efficacy of the Fit4Fun intervention for improving physical fitness in a sample of primary school children: a pilot study. Physical Education and Sport Pedagogy, 18(4), 389-411.
18. Eather, N., Morgan, P. J., & Lubans, D. R. (2013). Improving the fitness and physical activity levels of primary school children: results of the Fit-4-Fun group randomized controlled trial. Preventive Medicine, 56(1), 12-19.
19. Eather, N., Morgan, P. J., & Lubans, D. R. (2013). Social support from teachers mediates physical activity behavior change in children participating in the Fit-4-Fun intervention. International Journal of Behavioiral Nutrition and Physical Activity, 10, 68.
20. Eather, N., P. J. Morgan and D. R. Lubans (2011). Improving health-related fitness in children: The fit-4-Fun randomized controlled trial study protocol. BioMedical Central Public Health 11(902): 1-12.
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Public notes
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Contacts
Principal investigator
Name
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Mrs Narelle Eather
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Address
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The University of Newcastle
HPE310 University Drive
Callaghan, NSW, 2301
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Country
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Australia
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Phone
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+612 425302312
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Narelle Eather
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Address
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The University of Newcastle
School of Education
Callaghan Campus,
University Drive,
NSW, 2308.
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Country
16387
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Australia
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Phone
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+61 2 49216232
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Fax
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+61 2 49217407
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mrs Narelle Eather
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Address
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The University of Newcastle
School of Education
Callaghan Campus,
University Drive,
NSW, 2308.
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Country
7315
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Australia
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Phone
7315
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+61 2 49216232
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Fax
7315
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+61 2 49217407
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Email
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
Improving health-related fitness in children: the Fit-4-Fun randomized controlled trial study protocol.
2011
N.B. These documents automatically identified may not have been verified by the study sponsor.
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