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Trial registered on ANZCTR


Registration number
ACTRN12609000892213
Ethics application status
Approved
Date submitted
12/10/2009
Date registered
12/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
‘Go for your life’ Health Promoting Communities: Being Active Eating Well
Scientific title
A quasi-experimental multi-level intervention demonstration project with comparison group to increase community capacity to promote healthy eating and physical activity, measured by changes in community capacity, environments, health behaviours and anthropometry.
Secondary ID [1] 273223 0
Nil
Universal Trial Number (UTN)
Trial acronym
HPC: BAEW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 251989 0
Condition category
Condition code
Diet and Nutrition 252182 252182 0 0
Obesity
Public Health 252183 252183 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention groups: multiple strategies in schools, workplaces and community organisations to promote healthy eating and physical activity. Examples of strategies include school and workplace food policies, community kitchens and gardens, walking groups, parent education programs, social marketing, training of local professionals and promoting active transport. The duration of the trial is approximately 4 years.
Intervention code [1] 241402 0
Prevention
Comparator / control treatment
Comparison groups used in 5 of 6 projects. Comparison groups are exposed to any healthy eating and physical activities that may be occcuring coincidentally in the regions but no specific interventions will be instituted for this study.
Control group
Active

Outcomes
Primary outcome [1] 253058 0
Body mass index z-score
Timepoint [1] 253058 0
At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).
Secondary outcome [1] 257873 0
Behavioural indicators of healthy eating and physical activity, measured by questionnaire.
Timepoint [1] 257873 0
At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).
Secondary outcome [2] 257874 0
Waist circumference
Timepoint [2] 257874 0
At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).
Secondary outcome [3] 257875 0
Body mass index
Timepoint [3] 257875 0
At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).
Secondary outcome [4] 257876 0
Prevalence of overweight and obesity, measured by body mass index and waist circumference.
Timepoint [4] 257876 0
At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).
Secondary outcome [5] 257877 0
School and workplace environmental changes, as measured by school/workplace environmental audits and expert assessment.
Timepoint [5] 257877 0
At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).
Secondary outcome [6] 257884 0
Community capacity to effect behaviour change around overweight and obesity, as evidenced by the development of new structures and partnerships, staff development, community awareness etc (measured by expert assessment).
Timepoint [6] 257884 0
At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).

Eligibility
Key inclusion criteria
Each project has a primary and secondary target group, with comparison groups selected to match primary targets. Target groups include children 0-12, adolescents 12-18, young people newly arrived to Australia, families, carers, working adults, older adults, seniors and an indigenous community.
Minimum age
No limit
Maximum age
No limit
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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Intervention participants were non-randomly allocated to the intervention by school/workplace. Comparison schools and workplaces were randomly selected from the same community or matched areas of Victoria.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243863 0
Government body
Name [1] 243863 0
Department of Health, Victoria
Country [1] 243863 0
Australia
Funding source category [2] 243864 0
Government body
Name [2] 243864 0
Department of Planning and Community Development, Victoria
Country [2] 243864 0
Australia
Primary sponsor type
Government body
Name
Department of Health, Victoria
Address
50 Lonsdale St
Melbourne Vic 3000
Country
Australia
Secondary sponsor category [1] 237211 0
Government body
Name [1] 237211 0
Department of Planning and Community Development, Victoria
Address [1] 237211 0
1 Spring St
Melbourne Vic 3000
Country [1] 237211 0
Australia
Other collaborator category [1] 891 0
University
Name [1] 891 0
Deakin University
Address [1] 891 0
Waterfront campus
1 Gheringhap St
Geelong, Victoria 3217
Country [1] 891 0
Australia
Other collaborator category [2] 892 0
Other Collaborative groups
Name [2] 892 0
Campaspe Primary Care Partnership
Address [2] 892 0
PO Box 164
Rochester Vic 3561
Country [2] 892 0
Australia
Other collaborator category [3] 893 0
Other Collaborative groups
Name [3] 893 0
Kingston Bayside Primary Care Partnership
Address [3] 893 0
Central Bayside CHS
335-337 Nepean Hwy
Parkdale Vic 3195
Country [3] 893 0
Australia
Other collaborator category [4] 894 0
Government body
Name [4] 894 0
City of Kingston
Address [4] 894 0
34 Brindisi St, Mentone
PO Box 1000
Mentone Vic 3194
Country [4] 894 0
Australia
Other collaborator category [5] 895 0
Other Collaborative groups
Name [5] 895 0
Southern Grampians & Glenelg Primary Care Partnership
Address [5] 895 0
Gray Street
Hamilton Vic 3300
Country [5] 895 0
Australia
Other collaborator category [6] 896 0
Other
Name [6] 896 0
Western District Health Service
Address [6] 896 0
Foster Street
Hamilton Vic 3300
Country [6] 896 0
Australia
Other collaborator category [7] 897 0
Other Collaborative groups
Name [7] 897 0
South East Health Communities Partnership
Address [7] 897 0
Level 2/15 Scott Street
Dandenong Vic 3175
Country [7] 897 0
Australia
Other collaborator category [8] 898 0
Government body
Name [8] 898 0
Cardinia Shire Council
Address [8] 898 0
PO Box 7
Pakenham Vic 3810
Country [8] 898 0
Australia
Other collaborator category [9] 899 0
Other Collaborative groups
Name [9] 899 0
Westbay Primary Care Partnership
Address [9] 899 0
PO Box 5102
Sunshine Vic 3020
Country [9] 899 0
Australia
Other collaborator category [10] 900 0
Other
Name [10] 900 0
Western Region Health Centre
Address [10] 900 0
72-79 Paisley St, Footscray 3011 (primary site)
and
107-139 Churchill Ave, Braybrook 3019 (for study coordinators)
Country [10] 900 0
Australia
Other collaborator category [11] 901 0
Charities/Societies/Foundations
Name [11] 901 0
Wathaurong Aboriginal Co-operative
Address [11] 901 0
Lot 62 Morgan St
North Geelong Vic 3215
Country [11] 901 0
Australia
Other collaborator category [12] 902 0
University
Name [12] 902 0
Royal Melbourne Institute of Technology (RMIT) University
Address [12] 902 0
Ballarat Road
Hamilton Vic 3300
Country [12] 902 0
Australia
Other collaborator category [13] 903 0
University
Name [13] 903 0
Monash University
Address [13] 903 0
PO Box 197
Caulfied East Vic 3145
Country [13] 903 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243986 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 243986 0
Ethics committee country [1] 243986 0
Australia
Date submitted for ethics approval [1] 243986 0
Approval date [1] 243986 0
25/06/2008
Ethics approval number [1] 243986 0
EC 98-2008
Ethics committee name [2] 243987 0
Department of Human Services Human Research Ethics Committee
Ethics committee address [2] 243987 0
Ethics committee country [2] 243987 0
Australia
Date submitted for ethics approval [2] 243987 0
Approval date [2] 243987 0
Ethics approval number [2] 243987 0
Ethics committee name [3] 244111 0
University of Melbourne HREC
Ethics committee address [3] 244111 0
Ethics committee country [3] 244111 0
Australia
Date submitted for ethics approval [3] 244111 0
Approval date [3] 244111 0
04/05/2009
Ethics approval number [3] 244111 0
0931490.1

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

Contacts
Principal investigator
Name 30377 0
Address 30377 0
Country 30377 0
Phone 30377 0
Fax 30377 0
Email 30377 0
Contact person for public queries
Name 13624 0
Rebecca Doherty
Address 13624 0
Department of Health
50 Lonsdale St
Melbourne Vic 3000
Country 13624 0
Australia
Phone 13624 0
+61 3 9096 2211
Fax 13624 0
Email 13624 0
[email protected]
Contact person for scientific queries
Name 4552 0
Dr Michelle Haby
Address 4552 0
Department of Health
50 Lonsdale St
Melbourne Vic 3000
Country 4552 0
Australia
Phone 4552 0
+61 3 9096 5829
Fax 4552 0
Email 4552 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
SourceTitleYear of PublicationDOI
EmbaseThe effect of gender and age on the association between weight status and health-related quality of life in Australian adolescents.2014https://dx.doi.org/10.1186/1471-2458-14-898
N.B. These documents automatically identified may not have been verified by the study sponsor.