Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
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).
Secondary ID [1] 263023 0
Phase 1 of this trial was registered on the ANZCTR, Registration ID: ACTRN12610000642088
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 270748 0
Physical activity in primary school children 270749 0
Condition category
Condition code
Public Health 270926 270926 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) 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.
Intervention code [1] 269364 0
Behaviour
Intervention code [2] 269365 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] 279593 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 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).
Timepoint [1] 279593 0
Baseline, immediate post-intervention (10 weeks after basline measures) and 6-month follow-up.
Secondary outcome [1] 294005 0
1) Physical Activity will be assessed using at least 4 days of pedometery (3 week days and 1 weekend day)
Timepoint [1] 294005 0
Baseline, immediate post-intervention (10 weeks after basline measures) and 6-month follow-up.
Secondary outcome [2] 294006 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] 294006 0
Baseline, immediate post-intervention (10 weeks after basline measures) and 6-month follow-up.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Control received all resources and intervention materials
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
30/04/2011
Date of last data collection
Anticipated
Actual
20/12/2012
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 269825 0
Self funded/Unfunded
Name [1] 269825 0
Narelle Eather
Country [1] 269825 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
The University of Newcastle
University Drive,
Callaghan, NSW. 2308
Country
Australia
Secondary sponsor category [1] 268857 0
Other
Name [1] 268857 0
Sports Medicine Australia
Address [1] 268857 0
New South Wales
PO Box 3176
RHODES NSW 2138
Country [1] 268857 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271792 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 271792 0
Callaghan Campus,
University Drive, Callaghan, NSW, 2308.
Ethics committee country [1] 271792 0
Australia
Date submitted for ethics approval [1] 271792 0
Approval date [1] 271792 0
28/03/2010
Ethics approval number [1] 271792 0
H-2009-0397

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 33140 0
Mrs Narelle Eather
Address 33140 0
The University of Newcastle
HPE310 University Drive
Callaghan, NSW, 2301
Country 33140 0
Australia
Phone 33140 0
+612 425302312
Fax 33140 0
Email 33140 0
[email protected]
Contact person for public queries
Name 16387 0
Narelle Eather
Address 16387 0
The University of Newcastle
School of Education
Callaghan Campus,
University Drive,
NSW, 2308.
Country 16387 0
Australia
Phone 16387 0
+61 2 49216232
Fax 16387 0
+61 2 49217407
Email 16387 0
[email protected]
Contact person for scientific queries
Name 7315 0
Narelle Eather
Address 7315 0
The University of Newcastle
School of Education
Callaghan Campus,
University Drive,
NSW, 2308.
Country 7315 0
Australia
Phone 7315 0
+61 2 49216232
Fax 7315 0
+61 2 49217407
Email 7315 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseImproving 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.