Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000477426
Ethics application status
Approved
Date submitted
5/04/2016
Date registered
12/04/2016
Date last updated
12/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A quasi-experimental repeat cross-section evaluation to determine the effectiveness of the OPAL (Obesity Prevention and Lifestyle) Program at increasing healthy weight in children (9-11 years).
Scientific title
Outcomes evaluation of the OPAL (Obesity Prevention and Lifestyle) Program in South Australia
Secondary ID [1] 288938 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 298292 0
Condition category
Condition code
Public Health 298421 298421 0 0
Health promotion/education
Diet and Nutrition 298457 298457 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The OPAL (Obesity Prevention and Lifestyle) Program is delivered in 20 communities across South Australia for a period of 4.75 - 5 years. OPAL aims to increase healthy weight in children 0-18 years and their families through community by increasing healthy eating and physical activity. Two SA health staff (a senior strategic position and a graduate project support position whose backgrounds varied and included Nutrition & Dietetics, Sport & recreation, Health Promotion, Nursing, Social Work) were based in local government to bring about changes at the individual, community and environment levels through a series of projects designed to meet local need. The program while delivering evidence-based social marketing behaviour change messages each year, provided a suite of locally relevant projects targeting the following goal areas: home meals, food outlets, local food production and active travel, active leisure and use of parks and places. OPAL staff have reported delivering more than 2,440 local projects across the first 10 communities (range of n=35 to 531 projects in each community). These projects are recorded in an online project management system. The projects vary from installing drinking water fountains and play equipment within the local playground to, delivery of nutrition programs within a local primary school to a mail-out of OPAL social marketing theme-related pamphlets to all residents within the council area. These projects are too diverse and too numerous to describe here as is the nature of systems-wide, community-level interventions.
OPAL was a systems-wide approach targeting multiple sectors and settings across the community including the following sectors: education and training, planning, sports and recreation, transport, arts and culture, community development, media, health, business and commercial, tourism, environment and conservation. This includes a range of individualised settings based upon the community such as pre, primary and high schools, local butcher and businesses to local library and non-government organisations.

Intervention fidelity (program integrity and local adaptations) was the subject of a separate study: Zoe Richards; Iordan Kostadinov; Michelle Jones; Lucie Richard; Margaret Cargo. (2014) Assessing Implementation Fidelity and Adaptation in a community-based childhood obesity prevention intervention Health Education Research September 2014 doi: 10.1093/her/cyu053
Intervention code [1] 294410 0
Prevention
Intervention code [2] 294446 0
Lifestyle
Intervention code [3] 294447 0
Behaviour
Comparator / control treatment
20 comparison communities were matched on maternal education, index of relative social disadvantage and population of families. The comparison communities did not receive the OPAL intervention.
Control group
Active

Outcomes
Primary outcome [1] 297902 0
Proportion of participants in the healthy weight range. Objective measures of height (using a stadiometer) and weight (using digital scales) to calculate BMI z score of 9-11 year old children conducted within primary schools in intervention and comparison communities. .
Timepoint [1] 297902 0
3rd intervention year and final intervention year
Primary outcome [2] 297903 0
quality of life using self-report survey tool CHU9D
Timepoint [2] 297903 0
3rd intervention year and final intervention year
Secondary outcome [1] 322577 0
healthy eating - fruit and vegetable consumption using a self report survey tool assessing the number of serves they consumed on the previous day. These questions were drawn, where possible, from existing instruments with either proven validity or reliability (de Silva-Sanigorski AM, Bolton K, Haby M, Kremer P, Gibbs, L, Waters, E, et al: Scaling up community-based obesity prevention in Australia: background and evaluation design of the Health Promoting Communities: Being Active Eating Well initiative. BMC Public Health. 2010,10:65 and Booth ML, Denney-Wilson E, Okely AD, Hardy LL: Methods of the NSW Schools Physical Activity and Nutrition Survey (SPANS). J Sci Med Sport. 2005,8(3):284-93
Timepoint [1] 322577 0
3rd intervention year and final intervention year
Secondary outcome [2] 322578 0
physical activity levels using a self-report validated survey question: Over the last 7 days, on how many days were you physically active for a total of 60 min per day? based on a validated item from the Health Behavior of School Children Study Roberts C, Freeman J, Samdal O, Schnohr CW, de Looze ME, Nic Gabhainn S, et al: The Health Behaviour in School-aged Children (HBSC) study: methodological developments and current tensions. Int J Public Health. 2009,54 Suppl 2:140-50.
Timepoint [2] 322578 0
3rd intervention year and final intervention year
Secondary outcome [3] 322579 0
sedentary activity (operationalized as screen-time) using self report validated survey question: Over the last 7 days, on how many days did you get at least 120 minutes (or 2 hours) of screen time (TV, videogames or computer use) per day outside of school hours? based on a validated item from the Health Behavior of School Children Study Roberts C, Freeman J, Samdal O, Schnohr CW, de Looze ME, Nic Gabhainn S, et al: The Health Behaviour in School-aged Children (HBSC) study: methodological developments and current tensions. Int J Public Health. 2009,54 Suppl 2:140-50.
Timepoint [3] 322579 0
3rd intervention year and final intervention year
Secondary outcome [4] 322580 0
consumption of discretionary foods using a self-report survey determining the number of discretionary foods consumed on the previous day. These questions were drawn, where possible, from existing instruments with either proven validity or reliability (de Silva-Sanigorski AM, Bolton K, Haby M, Kremer P, Gibbs, L, Waters, E, et al: Scaling up community-based obesity prevention in Australia: background and evaluation design of the Health Promoting Communities: Being Active Eating Well initiative. BMC Public Health. 2010,10:65 and Booth ML, Denney-Wilson E, Okely AD, Hardy LL: Methods of the NSW Schools Physical Activity and Nutrition Survey (SPANS). J Sci Med Sport. 2005,8(3):284-93
Timepoint [4] 322580 0
3rd intervention year and final intervention year

Eligibility
Key inclusion criteria
Children 9-11 years in schools in intervention and matched comparison communities
Minimum age
9 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children aged 9-11 years with a disability or attending a specialist school.
Children whose school did not consent.
Children whose parents did not consent.

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
Actual
12/09/2011
Date of last participant enrolment
Anticipated
Actual
29/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
Final
2000
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 293292 0
Government body
Name [1] 293292 0
SA Health
Country [1] 293292 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 292093 0
None
Name [1] 292093 0
Address [1] 292093 0
Country [1] 292093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294764 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 294764 0
Ethics committee country [1] 294764 0
Australia
Date submitted for ethics approval [1] 294764 0
22/07/2010
Approval date [1] 294764 0
25/08/2011
Ethics approval number [1] 294764 0
5195

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

Contacts
Principal investigator
Name 64970 0
Prof Michelle Miller
Address 64970 0
Flinders University
PO Box 2100
Adelaide 5001 SA
Country 64970 0
Australia
Phone 64970 0
+61 8 7221 8855
Fax 64970 0
Email 64970 0
[email protected]
Contact person for public queries
Name 64971 0
Michelle Jones
Address 64971 0
SA Health
PO Box 287 Rundle Mall
Adelaide 5000 SA
Country 64971 0
Australia
Phone 64971 0
+61 8 8226 5072
Fax 64971 0
Email 64971 0
[email protected]
Contact person for scientific queries
Name 64972 0
Michelle Miller
Address 64972 0
Flinders University
PO Box 2100
Adelaide 5001 SA
Country 64972 0
Australia
Phone 64972 0
+61 8 72218855
Fax 64972 0
Email 64972 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
No additional documents have been identified.