Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000414213
Ethics application status
Approved
Date submitted
27/05/2009
Date registered
4/06/2009
Date last updated
4/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting Physical Activity and Preventing Obesity in Economically Disadvantaged Schools: The Physical Activity Leaders Program for Adolescent Boys
Scientific title
Effects of a School-based Physical Activity Program on Unhealthy Weight Gain, Physical Activity and Physical Fitness in Adolescent Boys
Universal Trial Number (UTN)
Trial acronym
PALs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 4864 0
Condition category
Condition code
Public Health 237216 237216 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will assess changes in physical activity and health-related fitness over a 6-month period. The study will evaluate the Physical Activity Leaders (PALs) program, which is a school-based physical activity intervention for low-active adolescent boys in economically disadvantaged secondary schools. The program will provide students with an opportunity to increase their knowledge, skills and attitudes toward physical activity and nutrition. The PALs program was developed in reference to Bandura's Social Cognitive Theory and the program will target the following mediators of behaviour change: self-efficacy, social support and self-monitoring. The intervention will include the following components:

1) Health-related fitness activities - the physical activity sessions will focus on resistance training and circuit training using elastic tubing resistance training devices.
2) Interactive seminars - the seminars will focus on strategies to promote physical activity and healthy eating, training principles and fitness programming. A summary of the key messages to be reinforced in the physical activity sessions and interactive seminars are listed below:

a) Monitor your physical activity, fitness, and nutrition levels
b) Use training principles to set goals for physical activity and fitness
c) Reduce your time spent watching television, using the computer and playing electronic games immediately after school
d) Provide physical activity social support for your family and friends
e) Keep track of fruit and vegetable intake (using goals/diary) and aim for 2 pieces of fruit and 5 servings of vegetables each day
f) Drink more water and swap sugary drinks for diet drinks
g) Consider your portion sizes and eat at the dinner table
h) Reduce your junk food snacks

Total number of sessions are provided below:
1) 8 x 90 minute sessions focusing on health-related fitness activities. These will be delivered during school sport (Term 3).
2) 8 x 30 minute sessions focusing on enjoyable physical activities. These will occur during lunch-time (Term 3).
3) 3 x 40 minute interactive seminars focusing on physical activity and nutrition and fitness leadership delivered during school sport or at lunch-time (start of Term 3, end of Term 3 and end of Term 4).
4) 6 x 30 minute physical activity mentoring sessions working with year 7 boys. Mentoring will take place during lunch-time (Term 4).
Intervention code [1] 236646 0
Behaviour
Intervention code [2] 236648 0
Prevention
Comparator / control treatment
Wait list control. Students in the control group will receive the intervention at the completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 238026 0
Anthropometric. (1) Height and weight- will be measured to using a portable scale and stadiometer. (2) Waist circumference- will measured using non-extensible steel tapes. (3) Fat mass and fat-free mass- will be determined using the ImpSFB7 bioelectrical impedance (BIA) machine. The ImpSFB7 is a single channel, tetra polar bioimpedance spectroscopy (BIS) device.
Timepoint [1] 238026 0
Baseline, 10-weeks and 6-months
Secondary outcome [1] 242170 0
1) Physical activity- will be assessed using Yamax pedometers, which will be worn for 5 week days and 1 weekend day. (2) Muscular strength- will be assessed using an isometric leg strength test and the 7-stage abdominal strength test. (3) Muscular endurance- will be assessed using the wall squat test and a timed push-up test.
Timepoint [1] 242170 0
Baseline, 10-weeks and 6-months
Secondary outcome [2] 242171 0
1) Mediators of behavior change- a questionnaire will be used to assess the following- physical activity self-efficacy, social support for physical activity, resistance training self-efficacy, resistance training outcome expectancy.
Timepoint [2] 242171 0
Baseline, 10-weeks and 6-months
Secondary outcome [3] 242172 0
1) Physical self-perception will be assessed using the Physical Self-Perception Profile for adolescents (Fox and Corbin, 1989).
Timepoint [3] 242172 0
Baseline, 10-weeks and 6-months
Secondary outcome [4] 242173 0
Nutrition behaviours will be assessed using items from the NSW Schools Physical Activity and Nutrition Survey (SPANS)
Timepoint [4] 242173 0
Baseline, 10-weeks, 6-months

Eligibility
Key inclusion criteria
Adolescents boys in year 9 (age 13-16) attending a secondary school identified as high priority by the NSW Department of Education and Training. Boys will be identified as low-active by physical education teachers at the study schools.
Minimum age
13 Years
Maximum age
16 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will also be ineligible if they currently have a medical condition or physical injury preventing testing or training.

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)
Four low socio-economic status (SES) secondary schools from the Hunter Region will be invited to participate in the study. Schools will be classified as low-SES based on the Priority Schools Program (PSP). The PSP was set up in 2006 by the NSW Department of Education & Training. Additional funding, staffing and consultancy are provided through the PSP to targeted government schools that support students from communities with the highest concentrations of low SES families.

1) Initial contact - Schools that satisfy the criteria above will be initially contacted by letter. School principals will be sent letters inviting their school to participate in the study.

2) Recruitment – Once schools have expressed interest in the project, the chief investigator (CI) will contact the schools and request an opportunity to present the research proposal to the physical education (PE) teaching staff. The PE staff will then be asked to identify students who they perceive to be low-active and/or not currently participating in organised sport or physical activity. Interested students will be provided with information and consent letters.
Once baseline data has been collected randomisation will occur at the school level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation method of coin tossing will be used to allocate schools to treatment conditions. This method ensures an equal chance of allocation to each group.
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
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1731 0
2308

Funding & Sponsors
Funding source category [1] 5028 0
Charities/Societies/Foundations
Name [1] 5028 0
Hunter Medical Research Institute
Country [1] 5028 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Callaghan Campus
University Drive
NSW 2308
Country
Australia
Secondary sponsor category [1] 4545 0
Charities/Societies/Foundations
Name [1] 4545 0
Hunter Medical Research Institute
Address [1] 4545 0
Lookout Road
New Lambton
Locked Bag 1
NSW 2310
Country [1] 4545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239125 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 239125 0
Ethics committee country [1] 239125 0
Australia
Date submitted for ethics approval [1] 239125 0
Approval date [1] 239125 0
02/03/2009
Ethics approval number [1] 239125 0
H-2008-0453

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

Contacts
Principal investigator
Name 29654 0
Address 29654 0
Country 29654 0
Phone 29654 0
Fax 29654 0
Email 29654 0
Contact person for public queries
Name 12901 0
Dr David Lubans
Address 12901 0
School of Education
Callaghan Campus
University Drive
NSW 2308
Country 12901 0
Australia
Phone 12901 0
+61 2 49212049
Fax 12901 0
+61 2 49217407
Email 12901 0
[email protected]
Contact person for scientific queries
Name 3829 0
Dr David Lubans
Address 3829 0
School of Education
Callaghan Campus
University Drive
NSW 2308
Country 3829 0
Australia
Phone 3829 0
+61 2 49212049
Fax 3829 0
+61 2 49217407
Email 3829 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4896Study results articleYeshttps://doi.org/10.1016/j.ypmed.2011.01.009 Lubans DR, Morgan PJ, Aguiar EJ, Callister R. Rand... [More Details] Lubans et al 2011 PALs outcome effects PM.pdf

Documents added automatically
No additional documents have been identified.