Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000105943
Ethics application status
Approved
Date submitted
21/01/2011
Date registered
31/01/2011
Date last updated
31/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
GLAMA (Girls! Lead! Achieve! Mentor! Activate!) and BLAST (Boys! Lead! Activate! Succeed Together!) Project: a leadership and physical activity intervention for Year 7 and Year 10 students.
Scientific title
A non randomised control study of a leadership and physical activity intervention for improving self confidence, self efficacy, social behaviour, school and social connectedness, and physical activity in Year 7 and Year 10 students.
Secondary ID [1] 253428 0
NIL
Universal Trial Number (UTN)
Nil
Trial acronym
GLAMA- Girls! Lead! Achieve! Mentor! Activate!
BLAST- Boys! Lead! Activate! Succeed Together!
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leadership in physical activity 260970 0
physical activity self efficacy 260971 0
school transition and connectedness 260972 0
Condition category
Condition code
Public Health 259107 259107 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over 3 days, Year 10 students will receive leadership training by an experienced physical educator that will enable them to successfully implement the GLAMA & BLAST programs.

The leadership training will be administered during classtime initially over 2 days, with a following day "refresher" course. The format will include an informal lecture environment with discussion and activities to reinforce concepts. Feedback will be provided. Leaders will have their own manuals to work through.

The leadership training focuses on the following topics; communication, leadership skills, problem solving, decision making, bullying, assisting year 7 transition and the actual GLAMA and BLAST activities.

The leadership training will be followed by supported implementation of the GLAMA and BLAST program whilst Year 7 students are on camp. It is during this 2 hour session that leaders will visit camp and introduce themselves, the program and commence the first session of leading their own groups. The ratio is one leader to 4-5 students- all of the same gender. Leaders will have the opportunity to debrief and discuss following this implementation.

Following this initial 2 hour implementation, leaders will lead groups for 6x 48 minute sessions throughout Term 1. Debrief and feedback will be provided after each session to assist with the independent implementation.

Year 7 participants will be involved in a total of 7 sessions, including the initial introductory session with their leader whilst they are on camp. Then 6 sessions of the program with their leader over term 1. All sessions will be supported by an experienced physical educator and normal classroom teachers.

The sessions run by leaders include activities that are a combination of physical, cognitive and team building activities based on amazing race and adventure racing concepts.
Intervention code [1] 257871 0
Behaviour
Intervention code [2] 257880 0
Lifestyle
Comparator / control treatment
Control group will consist of students in the same Year levels (Year 7 and 10) who are not undertaking the GLAMA or BLAST program.
The school has been matched for SES and in considered a "like" school
Control group
Active

Outcomes
Primary outcome [1] 261961 0
Self confidence, self effiacy, social behaviours, school and social connectedness
Timepoint [1] 261961 0
Leaders- post training, pre-program, post program questionnaire

Year 7 participants(Control & Intervention)
Pre and post including use of PedsQL (1999), Bandura (1994), Dishman (2004) and Adolescent Health and Social Environment Questionnaire (Patton et al, 2003)
Secondary outcome [1] 268884 0
Physical activity behaviours and readiness to change
Timepoint [1] 268884 0
Leaders & Year 7 participants (Control & Intervention)
Measured via questionnaire (Hagler et al, 2006) pre and post program.
Secondary outcome [2] 268885 0
Physical activity behaviour- whole day activity patterns measured using accelerometers.
Timepoint [2] 268885 0
Year 7 participants
Measure 3 whole day activity patterns on the program days over 7 weeks.
Measure 3 whole day activity patterns NOT on the program days within the same week a day, including a PE class.

Eligibility
Key inclusion criteria
Year 7 students
Year 10 students
Within a Secondary school in Victoria
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any students not in those year levels
No consent given
Not within a state secondary school

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The leaders (year 10) receive leadership training and implement the intervention. Year 7 students receive the intervention only.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3536 0
3084
Recruitment postcode(s) [2] 3537 0
3204

Funding & Sponsors
Funding source category [1] 258338 0
University
Name [1] 258338 0
Royal Melbourne Insitute of Technology
Country [1] 258338 0
Australia
Primary sponsor type
University
Name
Royal Melbourne Insitute of Technology
Address
School of Medical Sciences
Discipline of Exercise Sciences
Plenty Road
Bundoora, Victoria
3083
Country
Australia
Secondary sponsor category [1] 257493 0
None
Name [1] 257493 0
Address [1] 257493 0
Country [1] 257493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260315 0
RMIT Unversity Science Engineering and Health College Human Ethics Advisory Network
Ethics committee address [1] 260315 0
Plenty Road
Bundoora, Victoria
3083
Ethics committee country [1] 260315 0
Australia
Date submitted for ethics approval [1] 260315 0
14/09/2010
Approval date [1] 260315 0
10/11/2010
Ethics approval number [1] 260315 0
ASEHAPP 71-10
A&bSEHAPP 92-10

Summary
Brief summary
The GLAMA and BLAST project aims to assess the effect of a Year 10 peer leadership program on self efficacy, school connectedness and physical activity during Year 7 transition into Secondary School.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 32101 0
Address 32101 0
Country 32101 0
Phone 32101 0
Fax 32101 0
Email 32101 0
Contact person for public queries
Name 15348 0
Kate Jenkinson
Address 15348 0
School of Medical Sciences
Discipline of Exercise Sciences
Plenty Road
Bundoora, Victoria
3083
Country 15348 0
Australia
Phone 15348 0
+61 3 99257337
Fax 15348 0
+61 3 94678181
Email 15348 0
[email protected]
Contact person for scientific queries
Name 6276 0
kate Jenkinson
Address 6276 0
School of Medical Sciences
Discipline of Exercise Sciences
Plenty Road
Bundoora, Victoria
3083
Country 6276 0
Australia
Phone 6276 0
+61 3 99257337
Fax 6276 0
+61 3 94678181
Email 6276 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
No additional documents have been identified.