Trial from ANZCTR


Trial ID ACTRN12610001077055
Trial Status: Registered
Date Submitted: 2/12/2010
Date Registered: 7/12/2010
Retrospectively registered

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Public title Girls in Sport Action Research Project
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Group randomised controlled trial to assess the effect of a school-based intervention promoting moderate-to-vigorous physical activity of adolescent girls from secondary schools in New South Wales.
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Secondary ID [1] 253228 0
None
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UTN
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Trial acronym GIS
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Health condition(s) or problem(s) studied:
Physical inactivity 258762 0
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Low physical self-esteem 258764 0
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Low physical confidence 258765 0
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Condition category: Condition code:
Public Health Health promotion/education
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258910 258910 0 0

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Descriptions of intervention(s) / exposure The research project will involve 24 schools, 12 of which will be involved in the intervention and 12 as comparison schools. The agreement of the 12 comparison schools will be secured through a letter to each school. Four clusters of schools will be utilised in the Sydney, Illawarra, Hunter/New England and North Coast regions. This would allow a breadth of coverage across diverse socio-economic, rural, regional and urban schools. To address the geographical scope and the number of schools, we have a consortium of researchers as Chief Investigators, including academics with local knowledge and more immediate access to schools. The Chief Investigators will act as critical friends to schools within their region to provide ongoing support and assistance to these schools over the course of the project. The participants of the Girls in Sport intervention are only those Year 8 students (in 2009) who have consented to participate. The Girls in Sport program will look different in each school. The intervention schools will receive the Girls in Sport intervention which is individualised for each school and each school develops themselves based on information that was collected in the formative stage of the project. This stage identified needs and interests of girls and teachers. For most schools, the Girls in Sport intervention will take place in the school sport period each week (approximately two hours), however, for others it will focus on lunchtime activities, physical education, before, and/or after school periods. It will take place on a weekly basis, however, the duration and frequency will differ from school to school depending on their intervention. Mostly the strategies will be implemented by the PDHPE staff, however, schools are encouraged to establish a Girls in Sport committee which includes PDHPE teachers, teachers from different faculties and girls from different year groups.
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Intervention Code:
Behaviour 257697 0
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Prevention 257699 0
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Lifestyle 257700 0
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Comparator / control treatment The comparison schools will participate in their regular school sport. Comparison schools will be offered casual relief for teachers involved in the project, access to information collected from the research and funds to implement some of the strategies used by other schools at a later date. It is voluntary for these schools to implement these strategies at a later date.
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Control group Active
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Primary Outcome: Physical activity using accelerometers (MTI model 7164, GT1M and GT3X) 259766 0
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Timepoint: Baseline, 18-months 259766 0
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Secondary Outcome: Enjoyment of physical activity and school sport is to be assessed using the Physical Activity Enjoyment Scale (S-PACES; Dishman, Motl, Sallis et al, 2005). 268532 0
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Timepoint: Baseline, 18-months 268532 0
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Secondary Outcome: Physical activity self-efficacy will be measured using an eight-item questionnaire originally developed by Motl, et al. (2000). 268541 0
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Timepoint: Baseline, 18-months 268541 0
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Key inclusion criteria Adolescent girls in Year 8 (age 12-15) attending a public secondary school.
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Minimum age 12 Years
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Maximum age 15 Years
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Gender Females
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Healthy volunteers? Yes
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Key exclusion criteria Students will be ineligible if they have a medical condition or physical injury preventing testing or participation in the intervention.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) The NSW Department of Education and Training emailed all principals of secondary schools in NSW (N=500), calling for expressions of interest to participate in the Project. Interested schools were asked to contact the Department and then complete a profile for their school which was used to pair-match schools prior to randomization. This profile requested information about the school’s population (number of boys and girls), proportion of students from non-English speaking and Aboriginal and Torres Strait Islander backgrounds, number and total Grades teaching experience of the physical and health education staff, and how school sport and physical education were organised in the school. Schools were then matched based on these criteria in addition to their type of school (for example, girls only, central school [found in rural areas where primary and secondary schools are combined on the one site under the same school executive], and technology high schools and their geographic location. A member of the research team was then assigned to be a ‘critical friend’ at each school. This involved working with the school as it collected and interpreted their own data and assisting with the development, implementation, and evaluation of the school’s action plan. Within each school, all girls in Grade 8 (second Grade of secondary schooling) were invited to participate in the study. Information sheets and consent forms were distributed by staff, and students were required to return these in order to participate. If a student did not consent, they were still able to participate in the intervention activities but did not participate in data collection. The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed by contacting the holder of the allocation schedule who was 'off-site'.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) This was a group randomized trial with school as the unit of randomization. Each matched pair of schools was randomly allocated to the intervention or control group using a computer-based random number producing algorithm. This was undertaken by a researcher independent of the project and then communicated to the research team who informed each school of its allocation. Due to the timeframe of the study, formative research was required to be conducted in the intervention schools in Term 4 (October to December 2008). This meant randomization needed to occur prior to baseline data collection.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/01/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 1500
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 258171 0
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Name: New South Wales Department of Education and Training 258171 0
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Address: 35 Bridge Street
Sydney NSW 2000
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Country: Australia 258171 0
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Primary Sponsor Government body
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Name: New South Wales Department of Education and Training
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Address: 35 Bridge Street
Sydney NSW 2000
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Country: Australia
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Secondary Sponsor: None 257345 0
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Name: 257345 0
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Other Collaborator: University 251710 0
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Name: University of Sydney 251710 0
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Address: The University of Sydney
NSW 2006
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Country: Australia 251710 0
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Other Collaborator: University 251711 0
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Name: University of Newcastle 251711 0
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Address: University Drive
Callaghan NSW 2308
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Country: Australia 251711 0
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Other Collaborator: University 251712 0
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Name: University of New England 251712 0
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Address: University of New England
Armidale NSW 2351
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Country: Australia 251712 0
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Other Collaborator: University 251713 0
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Name: Southern Cross University 251713 0
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Address: Military Road
East Lismore NSW 2480
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Country: Australia 251713 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Wollongong Human Research Ethics Committee 260159 0
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Address: University of Wollongong
Northfields Ave
Wollongong NSW 2500
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Country: Australia 260159 0
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Approval Date: 04/12/2008 260159 0
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Submitted Date: 260159 0
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HREC: HE08/296 260159 0
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Brief summary The overarching aim of the project is to investigate the impact of a NSW Department of Education and Training (DET) initiated program designed to promote girls’ regular participation in sport and physical activity. The research will use both quantitative and qualitative methods to: assess changes in physical activity and sports participation over the duration of the Girls in Sport (GIS) project; measure the impact of the GIS intervention on the enjoyment of physical activity, social support and self-efficacy of female students; evaluate the impact of the professional learning and participation in the intervention on teachers involved in sport and physical education at the GIS intervention schools; and evaluate the impact of GIS interventions on functional links between schools and community sport, physical activity facilities and services.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Lauren Puglisi
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Address: University of Wollongong Northfields Ave Wollongong NSW 2500
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Country: Australia
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Tel: +61 2 42213321
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Fax: +61 2 4221 3892
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Email: lpuglisi@uow.edu.au
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Contact person for scientific queries
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Name: A/Pr Anthony Okely
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Address: University of Wollongong Northfields Ave Wollongong NSW 2500
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Country: Australia
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Tel: +61 2 42214641
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Email: tokely@uow.edu.au
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Contact person responsible for updating information
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Name: Dr Lauren Puglisi
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Address: University of Wollongong Northfields Ave Wollongong NSW 2500
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Country: Australia
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Fax: +61 2 42213892
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Email: lpuglisi@uow.edu.au
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Addition Cancer fields
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