Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000842561
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
13/08/2015
Date last updated
6/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Australian Capital Territory It's Your Move: a systems based community intervention to prevent obesity among adolescents
Scientific title
The Australian Capital Territory It's Your Move: a systems based community intervention to prevent obesity among adolescents
Secondary ID [1] 287160 0
None
Universal Trial Number (UTN)
Trial acronym
ACT IYM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 295726 0
Condition category
Condition code
Public Health 296005 296005 0 0
Epidemiology
Public Health 296054 296054 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ACT IYM included a number of intervention initiatives over the two year intervention period to support healthy nutrition and physical activity systems at school. School Project Officers participated in a two-day workshop prior to intervention commencement led by research investigators to inform on the aims of the intervention, to develop school specific objectives and action plans to meet aims and objectives. Intervention schools developed, implemented and evaluated a healthy food at school policy where foods available at school were categorised into 'traffic light' system based on nutritional quality. Red foods were low in nutritional value and were limited in the school. Schools addressed food technology streams to ensure nutrition theory and foods prepared at school were healthy. Foods available at school events were to be of nutritional value. Initiatives to support physical activity at school included increasing the number and range of organised sports at school, upgrading of equipment available for student use, and dedicating space for students to be physically active. Dedicated staff members were given roles of School Project Officers and were from Health or Physical Education backgrounds. School Project Officers championed change within schools and completed half yearly performance reports to monitor adherence to intervention objectives.
ACT Government funded the ACT IYM, with intervention school receiving $50,000 for intervention related expenses such as equipment, staff hours and advisory services (Nutrition Australia for example), and comparison schools received $5,000. This program was a joint Australian, State and Territory Government initiative under the National Partnership Agreement on Preventative Health.
Intervention code [1] 292433 0
Lifestyle
Intervention code [2] 292479 0
Prevention
Intervention code [3] 292480 0
Behaviour
Comparator / control treatment
No treatment other than normal initiatives external to the ACT IYM program from 2012 - 2014
Control group
Active

Outcomes
Primary outcome [1] 295676 0
Proportion (%) of adolescents overweight or obese, defined by World Health Organization criteria. Height and weight measurements were objectively measured by researchers trained in anthropometry and body image protection. Body Mass Index was calculated and overweight/obesity was defined by World Health Organization criteria.
Timepoint [1] 295676 0
8 weeks post intervention start and two year follow-up
Secondary outcome [1] 316193 0
Composite secondary outcome:
- self-reported nutrition and physical activity attitudes, knowledge and behaviours measured by Attitudes, Knowledge and Behaviour Questionnaire (Mathews et al., 2009)
- self-reported depressive symptomatology measured by Short Moods and Feelings Questionnaire (Angold et al., 1995)
Timepoint [1] 316193 0
8 weeks post intervention start and two year follow-up

Eligibility
Key inclusion criteria
Secondary school students in year 7 and 8 in 2012
Minimum age
11 Years
Maximum age
16 Years
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2012
Actual
15/03/2012
Date of last participant enrolment
Anticipated
Actual
31/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
634
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 291730 0
Government body
Name [1] 291730 0
Australian Capital Territory Health Directorate
Country [1] 291730 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gheringhap St, Geelong Victoria 3220
Country
Australia
Secondary sponsor category [1] 290405 0
None
Name [1] 290405 0
Nil
Address [1] 290405 0
Nil
Country [1] 290405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293281 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 293281 0
Ethics committee country [1] 293281 0
Australia
Date submitted for ethics approval [1] 293281 0
Approval date [1] 293281 0
14/02/2012
Ethics approval number [1] 293281 0
2012-015
Ethics committee name [2] 293282 0
ACT Government Education and Training Directorate
Ethics committee address [2] 293282 0
Ethics committee country [2] 293282 0
Australia
Date submitted for ethics approval [2] 293282 0
Approval date [2] 293282 0
09/03/2012
Ethics approval number [2] 293282 0
2012-00545-1

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

Contacts
Principal investigator
Name 59098 0
Prof Boyd Swinburn
Address 59098 0
Deakin University
221 Burwood Highway Melbourne Victoria 3125
Country 59098 0
Australia
Phone 59098 0
+61392517096
Fax 59098 0
Email 59098 0
[email protected]
Contact person for public queries
Name 59099 0
Lynne Millar
Address 59099 0
Deakin University
1 Gheringhap St Geelong Victoria 3220
Country 59099 0
Australia
Phone 59099 0
+61352278420
Fax 59099 0
Email 59099 0
[email protected]
Contact person for scientific queries
Name 59100 0
Lynne Millar
Address 59100 0
Deakin University
1 Gheringhap St Geelong Victoria 3220
Country 59100 0
Australia
Phone 59100 0
+61352278420
Fax 59100 0
Email 59100 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
EmbaseDepressive symptomatology, weight status and obesogenic risk among Australian adolescents: A prospective cohort study.2016https://dx.doi.org/10.1136/bmjopen-2015-010072
N.B. These documents automatically identified may not have been verified by the study sponsor.