Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000382875
Ethics application status
Approved
Date submitted
28/03/2012
Date registered
3/04/2012
Date last updated
2/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical Activity 4 Every1: preventing the decline in moderate-to-vigorous (MVPA) physical activity among students attending secondary schools in low-income communities
Scientific title
Physical Activity 4 Every1 a: a multi-component physical activity intervention aiming to prevent the decline in moderate-to-vigorous (MVPA) physical activity among students attending secondary schools in low-income communities
Secondary ID [1] 280236 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
PA4E1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Improvement in physical inactivity in Year 7 students in secondary schools in low-income communities' 286187 0
Condition category
Condition code
Public Health 286383 286383 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the Physical Activity 4 Every1 (PA4E1) program - a multi-component physical activity intervention which aims to prevent the decline in moderate-to-vigorous (MVPA) physical activity among students attending secondary schools in low-income communities.
The program will provide students with an opportunity to increase their knowledge, skills and attitudes toward physical activity. The PA4E1 program was developed in reference to Bandura's Social Cognitive Theory and will target the following mediators of behaviour change: self-efficacy, social support, personal regulation of health behaviour, environmental perceptions, outcome expectations and expectancies. The intervention will be delivered within consenting intervention schools, with support from an in-school physical activity consultant. Based on the evidence from descriptive and experimental research the intervention will comprise the following components:

Formal Curriculum
1. Implementation of teaching strategies to maximise student activity levels within physical education (PE) classes. Regular pedometer-based PE lessons and curriculum material will be introduced to assist students meet the recommended 50% of PE class time in MVPA.
2. Implementation of annual individual physical activity plans in Health and Physical Education (HPE) that include: fitness assessments; long and short term personal goals for improving or maintaining regular physical activity; specific actions and timelines to achieve those goals; methods to be used to record actions and assess progress; and rewards for achieving goals.
3. Modification of school policies that encourage low-active students to be more physically active. The policies within each intervention school will be reviewed with the aim of establishing policies that enhance physical activity, and modifying existing policies that may be inhibiting policies.
4. Implementation of enhanced sports programs for all students. All students will be scheduled to participate in age appropriate 10 week programs during sport while they are in Years 7, 8 or 9. The sports programs will be based on Program X (for girls) and PALs (for boys), both of which have been shown to be efficacious. The programs include; health-related fitness activities, pedometers for self-monitoring, lunch-time activities (PALs only), information for parents, e-mail support (Program X only) and interactive seminars.
5. Implementation of daily accessible evidence based PA programs for boys and girls during school breaks including increasing the availability of facilities and equipment.

Partnerships and Services
6. Implementation of weekly accessible after-school PA programs through linkages with community sporting groups or fitness industry.
7. Parent engagement: A number of strategies will be employed to encourage parents to; increase their children’s physical activity, be active with their children at home and in the community. Regular information will be sent to parents via existing schools newsletters and newly developed program newsletters to support the activities occurring within the school.

The overall duration in which these interventions will be applied is 1.5 school years.
Intervention code [1] 284575 0
Prevention
Intervention code [2] 284576 0
Lifestyle
Intervention code [3] 284577 0
Behaviour
Comparator / control treatment
Wait list control. Students in the control group will receive standard treatment (i.e. regular school sport program and health and physical education curriculum) during the intervention period. Following the intervention period, the control schools will receive an evaluation report along with the materials and equipment required to self deliver the intervention strategies at their own pace.
Control group
Active

Outcomes
Primary outcome [1] 286840 0
Physical activity (minutes of moderate-to-vigorous physical activity (MVPA) per day) using accelerometers (Actigraph GT3X+)
Timepoint [1] 286840 0
Baseline, 12-months and 24-months
Secondary outcome [1] 296799 0
Mediators of physical activity - a survey will be used to assess the following- physical activity self-efficacy, social support for physical activity, physical activity intentions, physical activity outcome expectations and expectancies, behavioural strategies for physical activity, environmental perceptions of the physical activity environment. The survey questions developed for a previous study (NEAT girls ACTRN12610000330044)
Timepoint [1] 296799 0
Baseline, 12-months and 24-months

Eligibility
Key inclusion criteria
Students in Year 7 (age 11-13) attending secondary schools in low-income communities. Schools will be classified as low-income based on being classified as disadvantaged by the SEIFA Index of Relative Socio-Economic Advantage/Disadvantage.
Minimum age
11 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with severe intellectual or phsyical disabilities.

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)
Secondary schools within the study region that meet the following criteria will be considered eligible: Government and Catholic schools; classified as being disadvantaged by the SEIFA Index of Relative Socio-Economic Advantage/Disadvantage; have between 120-200 Year 7 students (in order to provide adequate sample size); within a 2.5 hour radius of the study team; and are not participating in other major physical activity or health intervention studies will be included in the sampling frame. Ten secondary schools that meet this criteria will be invited to participate in the study. A random number function in Microsoft Excel will be used to determine the order in which eligible secondary schools are 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 will be sent to schools. Approximately two weeks after the invitation letter is sent to the school, School Principals will be contacted by phone by a member of the research team and invited to participate in the study. A face-to-face meeting will be 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 will then be provided with information and consent letters.
Following baseline data collection, the school, parents and students will receive a letter from the study team outlining if the school will form part of the intervention or control group.
Randomization of the secondary schools will be undertaken by a statistician, not involved in contacting schools or in the study delivery and will occur after baseline data collection to reduce participation bias from students, teachers and researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Secondary schools will be randomly allocated to the intervention or control condition using a computerised random number function in Microsoft Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait list control design. Participants assigned to the control group will receive the intervention at the completion of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5166 0
2250
Recruitment postcode(s) [2] 5162 0
2264
Recruitment postcode(s) [3] 5160 0
2289
Recruitment postcode(s) [4] 5165 0
2290
Recruitment postcode(s) [5] 5164 0
2299
Recruitment postcode(s) [6] 5163 0
2325
Recruitment postcode(s) [7] 5161 0
2428
Recruitment postcode(s) [8] 5167 0
2443

Funding & Sponsors
Funding source category [1] 284997 0
Government body
Name [1] 284997 0
NSW Ministry of Health - Heath Promotion Demonstration Grant
Country [1] 284997 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 283861 0
University
Name [1] 283861 0
University of Newcastle
Address [1] 283861 0
Callaghan Campus
University Drive Callaghan NSW 2308
Country [1] 283861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287003 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 287003 0
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 287003 0
Australia
Date submitted for ethics approval [1] 287003 0
Approval date [1] 287003 0
08/04/2011
Ethics approval number [1] 287003 0
11/03/16/4.05
Ethics committee name [2] 287004 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 287004 0
Callaghan Campus
University Drive Callaghan NSW 2308
Ethics committee country [2] 287004 0
Date submitted for ethics approval [2] 287004 0
Approval date [2] 287004 0
02/08/2011
Ethics approval number [2] 287004 0
H-2011-0210
Ethics committee name [3] 287005 0
Diocese of Maitland-Newcastle Catholic Schools Office
Ethics committee address [3] 287005 0
PO Box 714
Newcastle NSW 2300
Ethics committee country [3] 287005 0
Australia
Date submitted for ethics approval [3] 287005 0
Approval date [3] 287005 0
15/09/2011
Ethics approval number [3] 287005 0
N/A
Ethics committee name [4] 287006 0
State Education Research Approvals Process
Ethics committee address [4] 287006 0
Locked Bag 53
Darlinghurst NSW 1300
Ethics committee country [4] 287006 0
Australia
Date submitted for ethics approval [4] 287006 0
Approval date [4] 287006 0
08/06/2011
Ethics approval number [4] 287006 0
2011111

Summary
Brief summary
Physical Activity 4 Every1 (PA4E1) is a multi-component physical activity intervention implemented in secondary schools in low-income communities over two years, which aims to prevent the decline in moderate-to-vigorous (MVPA) physical activity among students. The study will be the first Australian study in disadvantaged schools with objectively measured outcome data over an extended follow up period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33993 0
Address 33993 0
Country 33993 0
Phone 33993 0
Fax 33993 0
Email 33993 0
Contact person for public queries
Name 17240 0
Rachel Sutherland
Address 17240 0
Locked Bag 10
Wallsend NSW Australia 2287
Country 17240 0
Australia
Phone 17240 0
+61 2 49246133
Fax 17240 0
+61 2 49246215
Email 17240 0
Rachel.Sutherland@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 8168 0
Rachel Sutherland
Address 8168 0
Locked Bag 10
Wallsend NSW Australia 2287
Country 8168 0
Australia
Phone 8168 0
+61 2 49246133
Fax 8168 0
+61 2 49246215
Email 8168 0
Rachel.Sutherland@hnehealth.nsw.gov.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
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