Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000385448
Ethics application status
Approved
Date submitted
31/05/2007
Date registered
23/07/2007
Date last updated
15/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
fun ’n healthy in Moreland! A 5-year school-community-based health promotion and obesity prevention study for primary school children.
Scientific title
A 5-year study in primary school children of a multi-strategy, community-based intervention promoting healthy eating and physical activity compared to standard school activities on Body Mass Index (BMI) and quality of life.
Universal Trial Number (UTN)
Trial acronym
fun ‘n healthy in Moreland!
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity. 1967 0
Condition category
Condition code
Diet and Nutrition 2065 2065 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions are multiple strategies over 5 years within primary schools and the community to build the community's capacity to promote healthy eating and physical activity with the use of community development workers provided to the schools. Examples include school food policies, improving school food services such as school canteens, school physical activity programs, curriculum on healthy eating and healthy bodies, activities promoting self esteem, playground redesign, and parent and community engagement.
Intervention code [1] 1797 0
Prevention
Comparator / control treatment
Comparison group is exposed to background activities in the region with no specific intervention strategies instituted.
Control group
Active

Outcomes
Primary outcome [1] 3148 0
BMI
Timepoint [1] 3148 0
Measured at baseline (2004) and at follow up (2009).
Secondary outcome [1] 4887 0
BMI
Timepoint [1] 4887 0
Captured at baseline (2004) and will be measured again at follow up (2009). Environmental impact changes will be measured mid-way in 2007.
Secondary outcome [2] 4888 0
BMI z-score
Timepoint [2] 4888 0
Captured at baseline (2004) and will be measured again at follow up (2009). Environmental impact changes will be measured mid-way in 2007.
Secondary outcome [3] 4889 0
Prevalence of overweight and obesity
Timepoint [3] 4889 0
Captured at baseline (2004) and will be measured again at follow up (2009). Environmental impact changes will be measured mid-way in 2007.
Secondary outcome [4] 4890 0
Behavioural indicators of healthy eating and physical activity
Timepoint [4] 4890 0
Captured at baseline (2004) and will be measured again at follow up (2009). Environmental impact changes will be measured mid-way in 2007.
Secondary outcome [5] 4891 0
Environmental assessments of school and home food and physical activity
Timepoint [5] 4891 0
Captured at baseline (2004) and will be measured again at follow up (2009). Environmental impact changes will be measured mid-way in 2007.
Secondary outcome [6] 4892 0
Quality of Life
Timepoint [6] 4892 0
Captured at baseline (2004) and will be measured again at follow up (2009). Environmental impact changes will be measured mid-way in 2007.

Eligibility
Key inclusion criteria
Inclusion for measurement: male and female students in Years prep-6 in selected schools in intervention and comparison areas within the City of Moreland.
Minimum age
4 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2210 0
Government body
Name [1] 2210 0
Department of Human Services (DHS)
Country [1] 2210 0
Australia
Funding source category [2] 2211 0
Government body
Name [2] 2211 0
Department of Sport and Recreation
Country [2] 2211 0
Australia
Primary sponsor type
University
Name
Deakin University.
Address
221 Burwood Highway
Burwood Victoria 3125
Australia
Country
Australia
Secondary sponsor category [1] 1994 0
Charities/Societies/Foundations
Name [1] 1994 0
Moreland Community Health Service
Address [1] 1994 0
11 Glenlyon Rd, Brunswick, VIC 3056
Country [1] 1994 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4044 0
Primary schools in the City of Moreland. Approved by: the Deakin University Human Research Ethics Committee
Ethics committee address [1] 4044 0
Ethics committee country [1] 4044 0
Australia
Date submitted for ethics approval [1] 4044 0
Approval date [1] 4044 0
Ethics approval number [1] 4044 0
EC 248-2004
Ethics committee name [2] 4045 0
Royal Children’s Hospital EHRC
Ethics committee address [2] 4045 0
Ethics committee country [2] 4045 0
Australia
Date submitted for ethics approval [2] 4045 0
Approval date [2] 4045 0
Ethics approval number [2] 4045 0
24059
Ethics committee name [3] 4046 0
Catholic Education Office
Ethics committee address [3] 4046 0
Ethics committee country [3] 4046 0
Australia
Date submitted for ethics approval [3] 4046 0
Approval date [3] 4046 0
Ethics approval number [3] 4046 0
GE04/0009
Ethics committee name [4] 4047 0
Department of Education and Training
Ethics committee address [4] 4047 0
Ethics committee country [4] 4047 0
Australia
Date submitted for ethics approval [4] 4047 0
Approval date [4] 4047 0
Ethics approval number [4] 4047 0
SOS002733

Summary
Brief summary
The primary purpose of this study is to test the impact of a community-based program aimed at promoting healthy eating and physical activity on changes in Body Mass Index (BMI) in primary school students. The hypothesis is that a community development/health promoting schools approach will reduce the levels of overweight and obesity in this group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27900 0
Address 27900 0
Country 27900 0
Phone 27900 0
Fax 27900 0
Email 27900 0
Contact person for public queries
Name 10986 0
Dr Lisa Gibbs
Address 10986 0
The McCaughey Centre: VicHealth Centre for the Promotion of Mental Health and Community Wellbeing
School of Population Health
Faculty of Medicine, Dentistry and Health Sciences
University of Melbourne
Level 5, 207 Bouverie Street, Carlton, 3053
Country 10986 0
Australia
Phone 10986 0
+61 (03) 8344 0920
+61 (0)439 393 917
Fax 10986 0
+61 3 9348 2832
Email 10986 0
lgibbs@unimelb.edu.au
Contact person for scientific queries
Name 1914 0
Professor Elizabeth Waters
Address 1914 0
The McCaughey Centre, Melbourne School of Population Health, The University of Melbourne
Coordinating Editor, Cochrane Public Health Review Group,
Level 5 207 Bouverie St, Carlton 3053
Country 1914 0
Australia
Phone 1914 0
+61 3 8344 3183
+61 (0)408 573 966
Fax 1914 0
+61 3 9348 2832
Email 1914 0
ewaters@unimelb.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
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