Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001075279
Ethics application status
Approved
Date submitted
14/12/2009
Date registered
15/12/2009
Date last updated
15/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kids - 'Go for your life': An initiative to support healthy eating and physical activity and reduce the risk of overweight and obesity in children
Scientific title
An initiative for children (0-12 years of age) to support healthy eating and physical activity and reduce the risk of overweight and obesity
Secondary ID [1] 1200 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 252385 0
Condition category
Condition code
Public Health 256567 256567 0 0
Health promotion/education
Diet and Nutrition 256576 256576 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kids - 'Go for your life' is a state-wide initiative aimed to improve healthy eating and physical activity levels of children and in doing so reduce the risk of overweight and obesity. Currently the initiative will be implemented for 5 years.

The primary element of the inititiative - the Award Program, works with primary schools and early childhood services, such as child care, family day care and kindergartens, to support healthy eating and physical activity through an Award Program, using a health promoting schools approach.

Involvement in the Award Program is voluntary and those settings that join are provided with free resources, professional development for staff and links with local health professionals to support them to make policy and practise changes to reach award status. These policy and practise changes include implementing a range of evidence based health promotion activities to promote and support children's healthy eating and physical activity, including these activities within policy and including these healthy messages within curriculum and communication with parents.

The program also builds the capacity of local communities to further support implementation of the Award Program in children's settings and promote broader supportive environments for children's healthy eating and phsycial activity.

Local capcacity is built through:
1. Developing networks of existing local health professionals and providing them with resources, training and support to implement the Award program locally within schools and services.
2. Funding is also provided to local governments to employ a local "champion" to drive the Award Program locally and influence local policies that will support healthy eating and physical activity for children.

Social marketing is also undertaken to support healthy eating and physical activity behaviour change within schools, early chilhood services and within the home.
Intervention code [1] 255687 0
Prevention
Intervention code [2] 255688 0
Lifestyle
Intervention code [3] 255689 0
Behaviour
Comparator / control treatment
No comparison
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257457 0
Children's healthy eating and physical activity behaviours and, therefore their risk of overweight and obesity. This outcome is assessed using questionnaires with staff and parents across each setting, focus groups and observation.
Timepoint [1] 257457 0
measured at 2 year timepoints for 6 years post implementation
Secondary outcome [1] 262628 0
healthy eating policies and practises within children's settings. This is assessed using questionnaires.
Timepoint [1] 262628 0
measured at 2 year timepoints for 6 years post implementation.
Secondary outcome [2] 262633 0
Local government capacity and policy to support children's healthy eating and physical activity. This is assessed using questionnaires, focus groups, case studies and key informant interviews.
Timepoint [2] 262633 0
measured at 3 yearly timepoints for 6 years post implementation.
Secondary outcome [3] 262634 0
Capacity of local organisations to promote and support healthy eating and physical activity for children. This will be assessed using questionnaires, key informant interviews and case studies.
Timepoint [3] 262634 0
measured at 3 yearly timepoints for 6 years post implementation.
Secondary outcome [4] 262635 0
Awareness of program and healthy messages by parents. This will be assessed using focus group testing and questionnaires.
Timepoint [4] 262635 0
measured at 3 yearly timepoints for 6 years post implementation.

Eligibility
Key inclusion criteria
Children in early childhood settings, including: primary school; kindergarten; child care; family day care.
Minimum age
0 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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)
Involvement in the intervention is voluntary - Schools and services join the program as members and receive a range of resources, training and support as they work through a number of criteria to improve their policies and practices and reach award status. Children attending these settings will be receiving the intervention.

In addition, local governments and local organisations can also nominate to promote and support the intervention locally.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No allocation was required for this intervention. The intervention is available to all schools and early childhood settings across Victoria.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
cross sectional for Award Program within schools and early childhood services.

Quasi-experimental for local governements and local organsiations
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256175 0
Government body
Name [1] 256175 0
Victorian Government - Go for your life initative
Country [1] 256175 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Cancer Council Victoria & Diabetes Australia - Vic
Address
C/
1 Rathdowne Street
Carlton
Victoria 3053
Country
Australia
Secondary sponsor category [1] 251515 0
University
Name [1] 251515 0
Melbourne University
Address [1] 251515 0
207Bouverie St
Carlton
VIC 3053
Country [1] 251515 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258277 0
Department of Human Services Victoria, Human Research Ethics Committee and the Department of Education and Early Childhood Development Victoria, Research in Schools Committee
Ethics committee address [1] 258277 0
Ethics committee country [1] 258277 0
Australia
Date submitted for ethics approval [1] 258277 0
Approval date [1] 258277 0
01/01/2007
Ethics approval number [1] 258277 0

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

Contacts
Principal investigator
Name 30614 0
Address 30614 0
Country 30614 0
Phone 30614 0
Fax 30614 0
Email 30614 0
Contact person for public queries
Name 13861 0
Dr. Suzy Honisett
Address 13861 0
Manager, Kids - 'Go for your life'
The Cancer Council Victoria and
Diabetes Australia - Vic
C/O 1 Rathdowne St
Carlton Vic 3053
Country 13861 0
Australia
Phone 13861 0
+61 3 9635 5422
Fax 13861 0
+ 61 3 8648 1826
Email 13861 0
[email protected]
Contact person for scientific queries
Name 4789 0
Dr. Lauren Prosser
Address 4789 0
The Cancer Council Victoria and
Diabetes Australia - Vic
C/O 1 Rathdowne St
Carlton Vic 3053
Country 4789 0
Australia
Phone 4789 0
+61 409533469
Fax 4789 0
+61 3 8648 1826
Email 4789 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.