Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001077055
Ethics application status
Approved
Date submitted
2/12/2010
Date registered
7/12/2010
Date last updated
7/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Girls in Sport Action Research Project
Scientific title
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.
Secondary ID [1] 253228 0
None
Universal Trial Number (UTN)
Trial acronym
GIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 258762 0
Low physical self-esteem 258764 0
Low physical confidence 258765 0
Condition category
Condition code
Public Health 258910 258910 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 257697 0
Behaviour
Intervention code [2] 257699 0
Prevention
Intervention code [3] 257700 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 259766 0
Physical activity using accelerometers (MTI model 7164, GT1M and GT3X)
Timepoint [1] 259766 0
Baseline, 18-months
Secondary outcome [1] 268532 0
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).
Timepoint [1] 268532 0
Baseline, 18-months
Secondary outcome [2] 268541 0
Physical activity self-efficacy will be measured using an eight-item questionnaire originally developed by Motl, et al. (2000).
Timepoint [2] 268541 0
Baseline, 18-months

Eligibility
Key inclusion criteria
Adolescent girls in Year 8 (age 12-15) attending a public secondary school.
Minimum age
12 Years
Maximum age
15 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be ineligible if they have a medical condition or physical injury preventing testing or participation in the intervention.

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



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258171 0
Government body
Name [1] 258171 0
New South Wales Department of Education and Training
Country [1] 258171 0
Australia
Primary sponsor type
Government body
Name
New South Wales Department of Education and Training
Address
35 Bridge Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 257345 0
None
Name [1] 257345 0
Address [1] 257345 0
Country [1] 257345 0
Other collaborator category [1] 251710 0
University
Name [1] 251710 0
University of Sydney
Address [1] 251710 0
The University of Sydney
NSW 2006
Country [1] 251710 0
Australia
Other collaborator category [2] 251711 0
University
Name [2] 251711 0
University of Newcastle
Address [2] 251711 0
University Drive
Callaghan NSW 2308
Country [2] 251711 0
Australia
Other collaborator category [3] 251712 0
University
Name [3] 251712 0
University of New England
Address [3] 251712 0
University of New England
Armidale NSW 2351
Country [3] 251712 0
Australia
Other collaborator category [4] 251713 0
University
Name [4] 251713 0
Southern Cross University
Address [4] 251713 0
Military Road
East Lismore NSW 2480
Country [4] 251713 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260159 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 260159 0
Ethics committee country [1] 260159 0
Australia
Date submitted for ethics approval [1] 260159 0
Approval date [1] 260159 0
04/12/2008
Ethics approval number [1] 260159 0
HE08/296

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

Contacts
Principal investigator
Name 31983 0
Address 31983 0
Country 31983 0
Phone 31983 0
Fax 31983 0
Email 31983 0
Contact person for public queries
Name 15230 0
Dr Lauren Puglisi
Address 15230 0
University of Wollongong
Northfields Ave
Wollongong
NSW 2500
Country 15230 0
Australia
Phone 15230 0
+61 2 42213321
Fax 15230 0
+61 2 4221 3892
Email 15230 0
[email protected]
Contact person for scientific queries
Name 6158 0
A/Pr Anthony Okely
Address 6158 0
University of Wollongong
Northfields Ave
Wollongong
NSW 2500
Country 6158 0
Australia
Phone 6158 0
+61 2 42214641
Fax 6158 0
+61 2 4221 3892
Email 6158 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
EmbaseA school-based intervention to promote physical activity among adolescent girls: rationale, design, and baseline data from the Girls in Sport group randomised controlled trial.2011
EmbasePromoting physical activity among adolescent girls: The Girls in Sport group randomized trial.2017https://dx.doi.org/10.1186/s12966-017-0535-6
N.B. These documents automatically identified may not have been verified by the study sponsor.