Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000257460
Ethics application status
Approved
Date submitted
10/05/2007
Date registered
14/05/2007
Date last updated
7/11/2018
Date data sharing statement initially provided
7/11/2018
Date results information initially provided
7/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
It's Your Move! A community-based obesity prevention study in secondary school children
Scientific title
A 3-year study in secondary school children of a multi-strategy, community intervention promoting healthy eating and physical activity compared to no specific interventions on changes in body size and composition
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent overweight and obesity 1796 0
Condition category
Condition code
Diet and Nutrition 1882 1882 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions are multiple strategies over 3 years within secondary schools and the community to build the community's capacity to promote healthy eating and physical activity. Examples include school food policies, improving school food service, within school and after school physical activity programs, training for coordinators and student ambassadors, curriculum on healthy eating and healthy bodies, activities around avoid ing fad diets and creating body size acceptance, social marketing, incorporating programs into local government strategic plans.
Intervention code [1] 1747 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] 2673 0
Percent body fat
Timepoint [1] 2673 0
Measured at baseline (2005) and at follow up (2008 or before as student leaves school)
Secondary outcome [1] 4532 0
Body mass index, body mass index z-score, prevalence of overweight and obesity, waist circumference, behavioural indicators of healthy eating and physical activity, quality of life, and knowledge indicators.
Timepoint [1] 4532 0
All will be measured at baseline (2005) and at follow up (2008 or before as student leaves school). School audits and community capacity measured in 2005 and 2008.

Eligibility
Key inclusion criteria
Students in Years 7-11 in selected schools in intervention and comparison areas.
Minimum age
12 Years
Maximum age
19 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
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
1/07/2005
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
1/07/2006
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
3000
Accrual to date
Final
2054

Funding & Sponsors
Funding source category [1] 2029 0
Government body
Name [1] 2029 0
National Health and Medical Research Council (NHMRC)
Country [1] 2029 0
Australia
Funding source category [2] 2030 0
Government body
Name [2] 2030 0
Department of Human Services (DHS), Victoria
Country [2] 2030 0
Australia
Funding source category [3] 2031 0
Charities/Societies/Foundations
Name [3] 2031 0
VicHealth
Country [3] 2031 0
Australia
Primary sponsor type
University
Name
School of Exercise and Nutrition Sciences, Deakin University
Address
Country
Australia
Secondary sponsor category [1] 1839 0
Other
Name [1] 1839 0
Newcomb Secondary College
Address [1] 1839 0
Country [1] 1839 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3761 0
Secondary schools in the Barown-SW region of Victoria. Approved by Deakin University Human Research Ethics Committee
Ethics committee address [1] 3761 0
Ethics committee country [1] 3761 0
Australia
Date submitted for ethics approval [1] 3761 0
Approval date [1] 3761 0
Ethics approval number [1] 3761 0
EC 37-2004, EC 22-2005, EC 337-2005
Ethics committee name [2] 3762 0
Secondary schools in the Barown-SW region of Victoria. Approved by Catholic Education Office
Ethics committee address [2] 3762 0
Ethics committee country [2] 3762 0
Australia
Date submitted for ethics approval [2] 3762 0
Approval date [2] 3762 0
26/04/2005
Ethics approval number [2] 3762 0
GE05/009
Ethics committee name [3] 3763 0
Secondary schools in the Barown-SW region of Victoria. Approved by Department of Education and Training
Ethics committee address [3] 3763 0
Ethics committee country [3] 3763 0
Australia
Date submitted for ethics approval [3] 3763 0
Approval date [3] 3763 0
16/06/2005
Ethics approval number [3] 3763 0
SOS002874

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 weight and body fat in adolescents. The hypothesis is that a community and student-led health promotion approach will reduce the levels of overweight and obesity in this group.
Trial website
Trial related presentations / publications
Millar L, Kremer P, de Silva-Sanigorski A, McCabe M, Mavoa H, Moodie M, Utter J, Bell C, Malakellis M, Mathews L, Roberts G, Robertson N, Swinburn B. Reduction in overweight and obesity from a 3 year community-based intervention in Australia: the ‘It’s Your Move!’ Project. Obes Rev 2011; 12(suppl 2):20-28
Public notes

Contacts
Principal investigator
Name 27850 0
Address 27850 0
Country 27850 0
Phone 27850 0
Fax 27850 0
Email 27850 0
Contact person for public queries
Name 10936 0
Louise Mathews
Address 10936 0
School of Exercise and Nutrition Sciences
Waterfront Campus
Deakin University
1 Gheringhap st
Geelong VIC 3127
Country 10936 0
Australia
Phone 10936 0
+61 3 52278420
Fax 10936 0
Email 10936 0
[email protected]
Contact person for scientific queries
Name 1864 0
Boyd Swinburn
Address 1864 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 1864 0
Australia
Phone 1864 0
+61 3 92517096
Fax 1864 0
Email 1864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.