Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000191392
Ethics application status
Approved
Date submitted
16/03/2008
Date registered
11/04/2008
Date last updated
11/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Sport 4 Fun Program: A Secondary School based physical activity program for adolescent girls
Scientific title
The Sport 4 Fun Program: A school-based movement skills program to improve the actual physical competence, perceived physical competence, enjoyment and participation in physical activity.
Universal Trial Number (UTN)
Trial acronym
The Sport 4 Fun Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity/inactivity 3030 0
Condition category
Condition code
Public Health 3183 3183 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial is a 20-week randomised control trial at a coeducational high school in the Macarthur Region of Sydney, NSW. The participants will be randomised into either the intervention or 'active' control group. The intervention program will consist of 3x15mins theory sessions, with two practical sessions (1x1.5 hours and 1 x 1.25 hours) each week. These sessions will focus on improving movement skills, perceived physical competence and enjoyment of physical activity as well as behaviour modification, motivation and goal setting activities.
Intervention code [1] 2659 0
Prevention
Intervention code [2] 2660 0
Lifestyle
Comparator / control treatment
The 'active' control group will receive scheduled sporting and homeroom activities, as already taught in the regular school environment.
Control group
Active

Outcomes
Primary outcome [1] 3950 0
Primary Outcome 1: Physical Activity, objectively measured using Accelerometers (MTI Health Services, Fort Walton Beach, FL, USA).
Timepoint [1] 3950 0
At Pre-test and post-test (25 weeks after pre-test, including school holidays)
Secondary outcome [1] 6636 0
Secondary outcome 1: Actual competence (Fundamental Movement Skills), video assessed using "Get Skilled, Get Active" (NSW DET, 2000).
Timepoint [1] 6636 0
At Pre-test and post-test (25 weeks after pre-test, including school holidays)
Secondary outcome [2] 6637 0
Secondary Outcome 2: Perceived Physical Competence, assessed using Harter's Perceived Competence Scale for Children.
Timepoint [2] 6637 0
At Pre-test and post-test (25 weeks after pre-test, including school holidays)
Secondary outcome [3] 6638 0
Secondary Outcome 3: Enjoyment of Physical Activity, assessed using a validated instrument among children and adolescent (Motl et al., 2001).
Timepoint [3] 6638 0
At Pre-test and post-test (25 weeks after pre-test, including school holidays)
Secondary outcome [4] 6639 0
Secondary Outcome 4: Anthropometry Measures of Height and Weight, assessed using Tanita HD646 Scales.
Timepoint [4] 6639 0
At Pre-test and post-test (25 weeks after pre-test, including school holidays)
Secondary outcome [5] 6640 0
Secondary Outcome 5: Anthropometry Measure of waist circumference, assessed using non-extensible steel tape, measured at the level of the mid point between the lower costal border and the iliac crest, by same gender assessors.
Timepoint [5] 6640 0
At Pre-test and post-test (25 weeks after pre-test, including school holidays)

Eligibility
Key inclusion criteria
Eighty students with the lowest cardio-respiratory results will be invited to participate in the trial. According to the NSW SPANS survey, in comparison to other girls of similar age, these girls' cardio-respiratory fitness results were lower than the 30th percentile (Booth et al., 2006).
Booth, M., Okely, A.D., Denney-Wilson, E., Hardy, L.L., Yang, B. & Dobbins, T. (2006). NSW Schools Physical Activity and Nutrition Survey (SPANS) 2004: Full Report. Sydney: NSW Department of Health.
Minimum age
12 Years
Maximum age
15 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Girls in only Year 7, 8 or 9 attending the school where the trial is being conducted are eligible. In addition, those students with medium to high levels of cardio-respiratory fitness (above the 30th percentile) were not invited to participate in the trial.

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)
Central randomisation by computer using bias coin method of allocation. The allocation code was only known by one of the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 611 0
2567

Funding & Sponsors
Funding source category [1] 3181 0
Other
Name [1] 3181 0
New South Wales Institute for Educational Research Inc.
Country [1] 3181 0
Australia
Primary sponsor type
Individual
Name
Dr Tony Okely
Address
Child Obesity Research Centre
Faculty of Education
University of Wollongong
Northfields Avenue,
Wollongong. NSW. 2500.
Country
Australia
Secondary sponsor category [1] 2851 0
Individual
Name [1] 2851 0
Phil Pearson
Address [1] 2851 0
Faculty of Education
University of Wollongong
Northfields Avenue,
Wollongong. NSW. 2500.
Country [1] 2851 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5165 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 5165 0
Ethics committee country [1] 5165 0
Australia
Date submitted for ethics approval [1] 5165 0
22/09/2007
Approval date [1] 5165 0
13/12/2007
Ethics approval number [1] 5165 0
HE05/06

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

Contacts
Principal investigator
Name 28438 0
Address 28438 0
Country 28438 0
Phone 28438 0
Fax 28438 0
Email 28438 0
Contact person for public queries
Name 11595 0
Jodie Andruschko
Address 11595 0
PDHPE Teacher
PO Box 222,
Narellan. NSW. 2567.
Country 11595 0
Australia
Phone 11595 0
+61 4647 7055
Fax 11595 0
Email 11595 0
[email protected]
Contact person for scientific queries
Name 2523 0
Dr Tony Okely
Address 2523 0
Child Obesity Research Centre
Faculty of Education
University of Wollongong
Northfields Ave,
Wollongong. NSW. 2500.
Country 2523 0
Australia
Phone 2523 0
+61 4221 4641
Fax 2523 0
Email 2523 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
No additional documents have been identified.