Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000860066
Ethics application status
Approved
Date submitted
11/10/2010
Date registered
14/10/2010
Date last updated
14/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Girls! Lead! Achieve! Mentor! Activate! project: a pilot leadership and physical activity intervention for Year 7 and Year 10 girls
Scientific title
A process evaluation of a pilot leadership and physical activity intervention for improving self confidence, self efficacy, social behaviours, school and social satisfaction in Year 7 and Year 10 Girls
Secondary ID [1] 252847 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
GLAMA- Girls! Lead! Achieve! Mentor! Activate!
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical activity stage of change 258364 0
physical activity pros and cons 258396 0
physical activity self efficacy 258397 0
self efficacy 258398 0
leadership 258399 0
quality of life 258400 0
Condition category
Condition code
Public Health 258542 258542 0 0
Health promotion/education
Diet and Nutrition 258565 258565 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Leadership Training (Year 10 Girls)

Over a 6 hour period, Year 10 girls will receive leadership training by an experienced physical educator that will enable them to successfully implement the GLAMA program.

The leadership training will be administerd during classtime in an informal lecture environment with discussion, activities to reinforce concepts and feedback provided. Leaders have their own manual to work through.

The leadership training focuses on the following topics: communication, leadership skills, dealing with groups, problem solving, decision making, motivation, and the GLAMA activities.


The leadership training will be followed by supported implementation of the GLAMA program within two Year 7 Physical Education (PE) classes with the same Year 7 girls on each occasion. The ratio is one leader to 4-5 Year 7 girls.

There will be follow-up leader only focus groups after the implementation in the PE classes. An important element of the leadership program is to provide the Year 10 girls with the skills to implement the GLAMA program independently over three lunchtimes. The focus groups will be once weekly after the implementation of the activities.

GLAMA program (Year 7 Girls)
Year 7 girls will be provided with the GLAMA program by the Year 10 girls during their regular timetabled physical education classtime for 2 weeks. The total duration is 1 x physical education class (120minutes) per week for two weeks. They will be supported by an experienced physical educator and their normal PE staff.

A further three lunchtime GLAMA sessions will be provided by the Year 10 girls. These lunchtime sessions will go for a total of 30 minutes, once a week for 3 weeks.

The activities are a combination of physical, cognitive and team building activities based on amazing race and adventure racing concepts.
Intervention code [1] 257367 0
Behaviour
Intervention code [2] 257368 0
Lifestyle
Intervention code [3] 257398 0
Prevention
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259379 0
Process evaluation of program, leadership training effectiveness (Year 10) and implementation (Year 7)
Timepoint [1] 259379 0
Immediately post leadership training/process questionnaire (week1, Year 10)

Focus groups/discussions/process questionnaire (post running each session)

Final Process questionnaire (post intervention- week7, Year 10)
Primary outcome [2] 259380 0
Self confidence, self efficacy, social behaviours, school and social satisfaction.
Timepoint [2] 259380 0
Measured via questionnaire Pre to post (7 weeks, Year 7 and 10)

PedSQL
Bandura's Self Efficacy Questionnaire
Dishman (2004) Physical Activity self efficacy
Primary outcome [3] 259413 0
Physical Activity behaviours and readiness for change
Timepoint [3] 259413 0
Measured via questionnaire Pre to post (7 weeks, Year 7 and 10)

Hagler, Calfas, Norman, Sallis & Patrick (2006)
Secondary outcome [1] 265904 0
Physical activity behaviours
Timepoint [1] 265904 0
All participants will wear an accelerometer for the whole day at the following time points;
Pre intervention- on the same day of the week as the intervention will be run
Weeks 1-2 (in class intervention)
Weeks 3-5 (lunchtime intervention)
Post intervention- on the same day of the week as the original PRE test

Eligibility
Key inclusion criteria
Year 7 Girls
Year 10 Girls
Within a Secondary School in Rural Victoria
Minimum age
11 Years
Maximum age
17 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Males
Any girls not in those Year levels
No consent given
Not in study 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 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
12/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3298 0
3730

Funding & Sponsors
Funding source category [1] 257815 0
University
Name [1] 257815 0
Royal Melbourne Institute of Technology(RMIT)
Country [1] 257815 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
School of Medical Sciences
Discipline of Excercise Sciences
Plenty Road
Bundoora, Victoria
3083
Country
Australia
Secondary sponsor category [1] 257019 0
None
Name [1] 257019 0
Address [1] 257019 0
Country [1] 257019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259836 0
RMIT University Science Engineering and Health College Human Ethics Advisory Network
Ethics committee address [1] 259836 0
Ethics committee country [1] 259836 0
Australia
Date submitted for ethics approval [1] 259836 0
Approval date [1] 259836 0
14/09/2010
Ethics approval number [1] 259836 0
ASEHAPP71-10
Ethics committee name [2] 259837 0
Department of Education and Early Childhood Development
Ethics committee address [2] 259837 0
Ethics committee country [2] 259837 0
Australia
Date submitted for ethics approval [2] 259837 0
Approval date [2] 259837 0
03/09/2010
Ethics approval number [2] 259837 0
2010_000829

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

Contacts
Principal investigator
Name 31754 0
Address 31754 0
Country 31754 0
Phone 31754 0
Fax 31754 0
Email 31754 0
Contact person for public queries
Name 15001 0
Kate Jenkinson
Address 15001 0
School of Medical Sciences
Discipline of Excercise Sciences
Plenty Road
Bundoora, Victoria
3083
Country 15001 0
Australia
Phone 15001 0
+61 3 99257337
Fax 15001 0
Email 15001 0
[email protected]
Contact person for scientific queries
Name 5929 0
Kate Jenkinson
Address 5929 0
School of Medical Sciences
Discipline of Excercise Sciences
Plenty Road
Bundoora, Victoria
3083
Country 5929 0
Australia
Phone 5929 0
+61 3 99257337
Fax 5929 0
Email 5929 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.