Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000331538
Ethics application status
Approved
Date submitted
18/03/2015
Date registered
13/04/2015
Date last updated
30/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Great Leaders, Active Students.- Evaluating the impact of a Peer Leadership Program for Grade 6 students on the movement skill competency and physical activity levels of students in Kindergarten, Grade 1 and 2
Scientific title
An efficacy study of a 10-week primary school peer-led fundamental movement skill intervention on children’s (aged 5-8) fundamental movement skill proficiency and physical activity.
Secondary ID [1] 286367 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
GLAS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity Prevention 294505 0
Condition category
Condition code
Public Health 294809 294809 0 0
Health promotion/education
Diet and Nutrition 294873 294873 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The GLAS program will run within the school for 10 weeks (i.e. 1 school term). The Yr6 student leaders will deliver 2 x 30min FMS sessions to students in K-Yr5 for the school term. In order for the Yr6 student leaders to be competent and confident to deliver the 10 week course they will receive the following evidence based components:
1. 1 x 3hr training for Yr6 student leaders. This workshop will be delivered during school sport by the research team. The workshop will address the following:
a. Qualities of good leaders: Yr6 student leaders will be provided an overview of transformational leadership and how to demonstrate these qualities to the K-Yr5 students for example being a good role model, being positive and enthusiastic.
b. Introduction to Fundamental Movement Skills (FMS). This will be a practical session (approx. 1.5hrs) where Yr6 student leaders are taught in small groups by a trained physical education teacher the basic components of 6 movement skills so that they can then deliver this to K-Yr5 students.
c. Running simple games and activities. The Yr6 student leaders will be taught by the physical education teacher how to run a 30 minute FMS session with the K-Yr5 students by introducing a warm up, basic skills practice and modified game.
2. Resources- schools will receive- equipment kits for the FMS sessions which will be taught, activity cards for leaders and handbooks for student leaders
3. Feedback for peer leaders- 1 and 3 weeks following the training Yr6 student leaders will receive a follow-up visit by the trained physical education teacher, who will observe them deliver a 30min FMS session to the K-Yr5 students and will provide the Yr6 student leaders positive feedback regarding the leadership practice and to problem solve any issues
4. Booster session (1 x 45 min session)- approx. week 5 of intervention all Yr6 student leaders will be provided another 45 min refresher session overviewing the important points of peer leadership and Fundamental Movement Skills (FMS).
Intervention fidelity and dose will be monitored through direct observation via research team attendance at GLAS sessions, physical education teacher’s attendance, student attendance sheets for both Yr6 student leaders and the K-Yr5 sessions.
Intervention code [1] 291427 0
Prevention
Intervention code [2] 291428 0
Behaviour
Intervention code [3] 291480 0
Lifestyle
Comparator / control treatment
Usual support - consisting of standard teacher development opportunities regarding healthy eating and physical activity programs in schools which could include staff training or resources.

The comparison school will be wait-list control and as such will be offered to receive the intervention in Term 3 2015.
Control group
Active

Outcomes
Primary outcome [1] 294555 0
The change in children's mean number of steps per school day as measured by pedometer.
Timepoint [1] 294555 0
Baseline and 10 weeks later
Primary outcome [2] 294556 0
The change in children's mean Fundamental Movement Skills (FMS) competency score will be assessed using TGMD3
Timepoint [2] 294556 0
Baseline and 10 weeks later
Secondary outcome [1] 313611 0
The change in children's mean leadership self-efficacy score will be assessed via student self report leadership self-efficacy survey.
Timepoint [1] 313611 0
Baseline and 10 weeks later

Eligibility
Key inclusion criteria
Schools- Two schools of convenience have been selected (one intervention, one comparison) for the efficacy trial.

Students- All students in Kinder to Year 6 will be invited to receive the intervention (as it is a whole school program). However. only children in K,1,2 and Yr 6 will be invited to participate in the evaluation of the program.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The School Principal will be sent an Information and Consent Letter describing the study. If the School Principal declines the study invitation we will contact another school. Once we have recruited a school, participants will learn about the study through a range of mediums including:
- announcements at school assembly delivered by the research team and
- classroom announcements delivered by teachers.
All students in Kindergarten, Grade 1, 2 and 6 at the study schools will be invited into the study by receiving an information sheet and consent letter by the research team at these announcements.
Participants will enter the study voluntarily. This will be explained to students, teachers and parents at the school and classroom announcements. Consent will be sought from both parent and child if interested to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/03/2015
Actual
23/03/2015
Date of last participant enrolment
Anticipated
27/03/2015
Actual
27/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9376 0
2289 - Adamstown
Recruitment postcode(s) [2] 9377 0
2291 - Merewether

Funding & Sponsors
Funding source category [1] 290935 0
University
Name [1] 290935 0
The University of Newcastle
Country [1] 290935 0
Australia
Funding source category [2] 290936 0
Government body
Name [2] 290936 0
Hunter New England Population Health
Country [2] 290936 0
Australia
Primary sponsor type
Individual
Name
Professor David Lubans
Address
School of Education
ATC Rm301C
Health and Physical Education Building Callaghan
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 289620 0
Individual
Name [1] 289620 0
Nicole Nathan
Address [1] 289620 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Australia
Country [1] 289620 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294710 0
The University of Newcastle
Ethics committee address [1] 294710 0
Ethics committee country [1] 294710 0
Australia
Date submitted for ethics approval [1] 294710 0
02/03/2015
Approval date [1] 294710 0
16/03/2015
Ethics approval number [1] 294710 0
H-2011-0214

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

Contacts
Principal investigator
Name 55738 0
Prof David Lubans
Address 55738 0
School of Education
ATC Rm301C
Health and Physical Education Building Callaghan
University Drive
Callaghan NSW 2308
Australia
Country 55738 0
Australia
Phone 55738 0
+61249212049
Fax 55738 0
+61249217407
Email 55738 0
David.Lubans@newcastle.edu.au
Contact person for public queries
Name 55739 0
David Lubans
Address 55739 0
School of Education
ATC Rm301C
Health and Physical Education Building Callaghan
University Drive
Callaghan NSW 2308
Australia
Country 55739 0
Australia
Phone 55739 0
+61249212049
Fax 55739 0
+61249217407
Email 55739 0
David.Lubans@newcastle.edu.au
Contact person for scientific queries
Name 55740 0
David Lubans
Address 55740 0
School of Education
ATC Rm301C
Health and Physical Education Building Callaghan
University Drive
Callaghan NSW 2308
Australia
Country 55740 0
Australia
Phone 55740 0
+61249212049
Fax 55740 0
+61249217407
Email 55740 0
David.Lubans@newcastle.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
No additional documents have been identified.