Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000373471
Ethics application status
Approved
Date submitted
10/05/2007
Date registered
16/07/2007
Date last updated
16/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Be Active Eat Well in Colac
Scientific title
A 3-year study in primary school children of multiple strategies to build the community's capacity to promote healthy eating and physical activity compared to no specific interventions on body size and waist circumference
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity in children. 1953 0
Condition category
Condition code
Diet and Nutrition 2048 2048 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Multiple strategies over 3 years in the schools and community to promote healthy eating and physical activity. Examples of strategies include school food policies, active after school programs, reducing TV viewing programs, school fruit activities, programs with local fast food outlets to improve the quality of food, parent education programs, social marketing, training of professionals and promoting active transport.
Intervention code [1] 1748 0
Prevention
Comparator / control treatment
Comparison group: exposed to background activities in the region but no specific interventions instituted. 2-year duration of follow up of the comparison group.
Control group
Active

Outcomes
Primary outcome [1] 2877 0
Body mass index z-score
Timepoint [1] 2877 0
At baseline (2003) and follow up at 3 years (2006)
Secondary outcome [1] 4847 0
Waist circumference
Timepoint [1] 4847 0
All measurements at baseline (2003) and follow up (2006)
Secondary outcome [2] 4848 0
Body mass index
Timepoint [2] 4848 0
All measurements at baseline (2003) and follow up (2006)
Secondary outcome [3] 4849 0
Prevalence of overweight and obesity
Timepoint [3] 4849 0
All measurements at baseline (2003) and follow up (2006)
Secondary outcome [4] 4850 0
Indicators of healthy eating and physical activity
Timepoint [4] 4850 0
All measurements at baseline (2003) and follow up (2006)
Secondary outcome [5] 4851 0
School environmental audits
Timepoint [5] 4851 0
All measurements at baseline (2003) and follow up (2006)
Secondary outcome [6] 4852 0
Community capacity.
Timepoint [6] 4852 0
All measurements at baseline (2003) and follow up (2006)

Eligibility
Key inclusion criteria
All children in kindergarten and primary schools (enrollment >20) in the intervention community and the randomly selected areas for the comparison group.
Minimum age
3 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to measure height or weight

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)
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2003
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] 2191 0
Government body
Name [1] 2191 0
Department of Human Services, Victoria
Country [1] 2191 0
Australia
Funding source category [2] 2192 0
Government body
Name [2] 2192 0
Australian Department of Health and Ageing
Country [2] 2192 0
Australia
Funding source category [3] 2193 0
Charities/Societies/Foundations
Name [3] 2193 0
VicHealth
Country [3] 2193 0
Australia
Primary sponsor type
University
Name
School of Exercise and Nutrition Sciences, Deakin University
Address
Country
Australia
Secondary sponsor category [1] 1977 0
Government body
Name [1] 1977 0
Colac Area Health
Address [1] 1977 0
Country [1] 1977 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3991 0
All primary schools in the Barwon-SW region of Victoria-Deakin University Human Research Ethics Committee
Ethics committee address [1] 3991 0
Ethics committee country [1] 3991 0
Australia
Date submitted for ethics approval [1] 3991 0
Approval date [1] 3991 0
05/03/2003
Ethics approval number [1] 3991 0
EC 20-2003

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

Contacts
Principal investigator
Name 27851 0
Address 27851 0
Country 27851 0
Phone 27851 0
Fax 27851 0
Email 27851 0
Contact person for public queries
Name 10937 0
Andrea Sanigorski
Address 10937 0
Deakin University
Waterfront Campus
1 Gheringhap St
Geelong VIC 3217
Country 10937 0
Australia
Phone 10937 0
+61 3 52270369
Fax 10937 0
Email 10937 0
andrea.sanigorski@deakin.edu.au
Contact person for scientific queries
Name 1865 0
Boyd Swinburn
Address 1865 0
Deakin University
221 Burwood Highway
Melbourne VIC 3125
Country 1865 0
Australia
Phone 1865 0
+61 3 92517096
Fax 1865 0
Email 1865 0
boyd.swinburn@deakin.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
No additional documents have been identified.