Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000446662
Ethics application status
Approved
Date submitted
11/04/2014
Date registered
30/04/2014
Date last updated
30/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting physical activity and wellbeing of rural- and regional-living girls
Scientific title
Effect of a school-community program on physical activity and wellbeing among adolescent girls living in low-socioeconomic rural and regional settings
Secondary ID [1] 284062 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
wellbeing 291668 0
Public Health 291118 0
physical inactivity 291667 0
Condition category
Condition code
Public Health 291460 291460 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A school- community-linked program was designed, implemented and evaluated in a cluster-randomised-controlled trial. The intervention program included a school and community component, which were underpinned with student-centered teaching and coaching approaches and behavioral skill-development theory.

The school component involved two six-session units – sport unit (football or tennis) and recreational unit (YMCA) – which were incorporated into the physical education curriculum for Year 7 - 9 girls. The classes were delivered in a collaborative manner by PE teachers, community fitness instructors and sports coaches. The school component was conceptually and practically linked to PA opportunities for continued participation outside school in sports clubs and recreation facilities via a subsequent 8-week program that was promoted during the school component.

The theoretical framework for the intervention was the socioecological model that was underpinned by both individual-level (social cognitive theory) and organizational-level (building organizational/community capacity) strategies.
Capacity-building strategies were applied to create supportive school and
community environments that facilitate the engagement of girls in physical activities (i.e., the organizations and communities). PE teachers, coaches and instructors were provided with professional development opportunities and program resources (e.g. lesson plans).

This was a real-world intervention and the frequency and duration varied slightly between settings; particularly as all schools organise PE timetabling differently. The program was designed on the basis that the school program equated to approx. 1 x 100min session per week for 6 weeks per unit, however sometimes this was delivered as 2 x 50min sessions per week for 6 weeks per unit.
Each student received two units during the 2011 school year and the school program was followed by a subsequent 8-week community program which was generally 45 – 60 minutes once a week for 8 weeks per unit.

Strategies to monitor adherence relied on the teachers and coaches keeping attendance logs.
Intervention code [1] 288756 0
Prevention
Intervention code [2] 288757 0
Lifestyle
Intervention code [3] 289235 0
Behaviour
Comparator / control treatment
The control arm involved schools going about their usual curricular and co-curricular programming and did not include any engagement strategy beyond those currently employed on a routine basis by the intervention program partners: Tennis Victoria, Football Federation Victoria and YMCA Victoria.
Control group
Active

Outcomes
Primary outcome [1] 291442 0
Health-related Quality of Life (HRQoL) measured using PedsQL 4.0 Generic Core Scales for Teens aged 13 – 18
Timepoint [1] 291442 0
baseline and 12-months
Primary outcome [2] 291441 0
Physical activity (MET-mins of leisure-time moderate-vigorous physical activity, using self-report PD-PAR24)
Timepoint [2] 291441 0
baseline and 12-months
Secondary outcome [1] 306777 0
Physical activity mediators - self report survey to assess: perceived sports competence, self management, perceived behavioral control, outcome expectation and expectancy value, self-efficacy, enjoyment, barriers, family and friend support.

The survey was designed specifically for this study and where possible (in most cases) validated questions were used to assess the outcomes.
Timepoint [1] 306777 0
baseline and 12-months

Eligibility
Key inclusion criteria
Year 7 - 9 female students attending schools in low-SES non-metropolitan communities in the Australian state of Victoria with the requisite combination of sports clubs and leisure centres for potential delivery of the intervention.

School communities were classified as low-income based on being classified as disadvantaged by the SEIFA Index of Relative Socio-Economic Advantage/Disadvantage.
Minimum age
12 Years
Maximum age
15 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

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)
Low-SES non-metropolitan communities in the Australian state of Victoria that had the requisite combination of sports clubs and leisure centres for delivery of the community component of the intervention were identified. The communities were matched in pairs on population size with one randomly selected community receiving the intervention, and the other acting as a control. Government and Catholic schools within these matched communities were then eligible for inclusion. A random number function in Microsoft Excel was used to determine the order in which eligible secondary schools were approached to participate in the study.

A letter inviting schools to be involved in the project and detailing all levels of involvement by all parties was sent to schools. School Principals were then contacted by phone by a member of the research team and invited to participate in the study. A face-to-face meeting was requested with both the Principal and the Head PE teacher to outline the requirements of the study and gain consent. Parents, students and PE staff were then provided with information and consent letters.

Schools were assigned to control or intervention and all female students within the school were eligible. Concealment was not required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Communities were randomly allocated to the intervention or control condition using a computerised random number function in Microsoft Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
4/10/2010
Date of last participant enrolment
Anticipated
6/05/2011
Actual
3/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
788
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288693 0
Other Collaborative groups
Name [1] 288693 0
Tennis Victoria
Country [1] 288693 0
Australia
Funding source category [2] 288691 0
Government body
Name [2] 288691 0
Department of Planning and Community Development–Sport and Recreation Victoria
Country [2] 288691 0
Australia
Funding source category [3] 288692 0
Charities/Societies/Foundations
Name [3] 288692 0
Helen Macpherson Smith Trust
Country [3] 288692 0
Australia
Funding source category [4] 288689 0
Government body
Name [4] 288689 0
Australian Research Council
Country [4] 288689 0
Australia
Funding source category [5] 288690 0
Government body
Name [5] 288690 0
The Victorian Health Promotion Foundation
Country [5] 288690 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Victoria University
Footscray Park Campus
Ballarat Rd. Footscray
PO Box 14428
Melbourne Vic 8001
Australia
Country
Australia
Secondary sponsor category [1] 287397 0
University
Name [1] 287397 0
Federation University Australia
Address [1] 287397 0
PO Box 663,
University Drive, Mt Helen
Vic 3353
Australia
Country [1] 287397 0
Australia
Other collaborator category [1] 277815 0
Other Collaborative groups
Name [1] 277815 0
Football Federation Victoria
Address [1] 277815 0
Level 3
436 St Kilda Road
Melbourne, VIC 3004
Country [1] 277815 0
Australia
Other collaborator category [2] 277816 0
Other Collaborative groups
Name [2] 277816 0
YMCA Victoria
Address [2] 277816 0
582 Heidelberg Road
Fairfield VIC 3078
Country [2] 277816 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290535 0
Federation Univeristy Australia (formerly University of Ballarat)
Ethics committee address [1] 290535 0
Ethics committee country [1] 290535 0
Australia
Date submitted for ethics approval [1] 290535 0
Approval date [1] 290535 0
18/09/2009
Ethics approval number [1] 290535 0
A09-133

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

Contacts
Principal investigator
Name 46134 0
Prof Warren Payne
Address 46134 0
Pro Vice-Chancellor (Research and Research Training)
Victoria University
Footscray Park Campus
Ballarat Rd. Footscray
PO Box 14428
Melbourne Vic 8001
Australia
Country 46134 0
Australia
Phone 46134 0
+61399195930
Fax 46134 0
Email 46134 0
warren.payne@vu.edu.au
Contact person for public queries
Name 46135 0
Meghan Casey
Address 46135 0
Federation University Australia
PO Box 663
Ballarat, Victoria 3353
Country 46135 0
Australia
Phone 46135 0
+61353279658
Fax 46135 0
Email 46135 0
m.casey@federation.edu.au
Contact person for scientific queries
Name 46136 0
Meghan Casey
Address 46136 0
Federation University Australia
PO Box 663
Ballarat, Victoria 3353
Country 46136 0
Australia
Phone 46136 0
+61353279658
Fax 46136 0
Email 46136 0
m.casey@federation.edu.au

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
EmbaseEffectiveness of a school-community linked program on physical activity levels and health-related quality of life for adolescent girls.2014https://dx.doi.org/10.1186/1471-2458-14-649
EmbaseLinking secondary school physical education with community sport and recreation for girls: a process evaluation.2014https://dx.doi.org/10.1186/1471-2458-14-1039
N.B. These documents automatically identified may not have been verified by the study sponsor.