Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001148662
Ethics application status
Approved
Date submitted
9/10/2014
Date registered
30/10/2014
Date last updated
1/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of multi-component school-based nutrition and canteen intervention on implementation of a government healthy canteen policy in primary schools
Scientific title
Are primary schools that receive a multi-component intervention of school-based nutrition and canteen support more likely than primary schools that receive usual support to implement a canteen menu consistent with a government healthy canteen policy?
Secondary ID [1] 285469 0
Nil
Universal Trial Number (UTN)
Trial acronym
SNACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity Prevention 293246 0
Condition category
Condition code
Public Health 293513 293513 0 0
Health promotion/education
Diet and Nutrition 293514 293514 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include the following evidence based components over a 9-month period (three school terms):
1. Executive support– The Principal will be encouraged to communicate their support for the healthy canteen intervention to Canteen Managers and P&C group by encouraging their participation in a professional development workshop and consent to receiving ongoing support.
2. Consensus processes–Consensus processes with the Canteen Manager and canteen staff will be conducted to reach agreement regarding the implementation of the healthy canteen strategy. Support staff will assist Canteen Managers to develop a local Canteen Action Plan (CAP) to co-ordinate implementation tasks. .
3. Staff training – A one day (5 hour) training workshop will be provided to Canteen Managers and parent representatives will provide education and skill development in nutrition, canteen stock and financial management, pricing and promotion, and change management. Training will combine didactic and interactive components including opportunities for self-assessment, role play and facilitator provided feedback. The training will be facilitated by Dietitians experienced in delivering this training to canteen managers.
4. Tools and resources - Printed instructional materials, sample policies/menus, planning templates, pricing guides, product lists of policy compliant menu items, supplier contacts and menu assessment feedback will be provided to all school Canteen Managers. Such resources will be sourced from the Department of Education and Communities, Nutrition Australia, and the Healthy Kids Association.
5. On-going support– Following training, canteen managers will receive two support contacts per school term (via email, telephone, text message or in person) for 9 months to continue to help them with assessing and categorising menu item and pricing and promotion strategies. These contacts will also be used to encourage canteen managers to review progress, discuss deficits identified from self-monitoring; and facilitate problem solving to policy implementation.
6. Recognition- Schools assessed during intervention period as compliant with the canteen policy will be sent a congratulatory letter and telephoned from the Project Co-ordinator. Menu compliant schools will also be promoted to other intervention schools using marketing strategies (see below).
7. Performance monitoring and feedback– two menu reviews will be used to compile written feedback report to the Canteen Manager, P&C and School Principal. The reports will include graphs comparing progress toward implementation of the healthy canteens policy Verbal feedback and discussion of feedback reports will also occur during telephone support calls.
8. Marketing strategies –Principals and parent groups will receive a letter overviewing the support available and encouraging their participation in the program. Project newsletters will be used to communicate key messages and case study successful implementation approaches. Schools will be encouraged to communicate the need for implementation to staff, parents and students via usual communication strategies.
Intervention code [1] 290404 0
Prevention
Intervention code [2] 290405 0
Behaviour
Comparator / control treatment
All comparison schools will receive usual support which includes; access to standard teacher development opportunities regarding healthy eating and physical activity programs which could include staff training or resources through the Healthy Children’s Initiative. Schools, that are members of the Healthy Kids Assn. may have access to Fresh Tastes @ School resources and implementation support.
Control group
Active

Outcomes
Primary outcome [1] 293329 0
The proportion of schools with a canteen menu containing foods or beverages prohibited (‘red’ and ‘banned’ items) under the Fresh Tastes @ School policy. Each menu will be audited by two independent Dietitians blind to group allocation. The Dietitians will categorise menu items as ‘red’, ‘amber’ or ‘green’ according to the criteria specified by Fresh Tastes @ School. Dietitians will use the Healthy Kids Association Assumptions Guide to assist with item classification.
Timepoint [1] 293329 0
Baseline and post intervention (3 school terms or approximately 9 months post randomisation)
Primary outcome [2] 293330 0
The proportion of schools where healthy canteen items represent the majority (>50%) of products listed on the menu as recommended by the Fresh Tastes @ school policy. The Dietitians will categorise menu items as ‘red’, ‘amber’ or ‘green’ according to the criteria specified by Fresh Tastes @ School. Information required to classify menu items that is not provided on the canteen menu will be collected from: nutrition information panels on products during canteen visits, by observation, or via interviews with Canteen Managers (for prepared products such as muffins, cakes or sandwiches). Dietitians will use the Healthy Kids Association Assumptions Guide to assist with item classification.
Timepoint [2] 293330 0
Baseline and post intervention (3 school terms or approximately 9 months post randomisation)
Secondary outcome [1] 310800 0
Nil
Timepoint [1] 310800 0
Nil

Eligibility
Key inclusion criteria
A random selection of Government and Catholic primary schools within the Hunter New England Local Health District of NSW, with a school canteen, will be invited to participate.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools from the Australian Independent Schools Association will be ineligible as implementation of the Fresh Tastes @ School canteen policy is not mandated for such schools. Schools with secondary students (central schools), catering exclusively for children requiring specialist care, and schools without a canteen will also be ineligible. Lastly, schools currently implementing obesity prevention policies and practices to a high standard, as defined by local health service school environment monitoring data at baseline will be excluded.

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)
Lists of Department of Education and Communities and Catholic Schools Office primary schools in the Hunter New England region will serve as the sampling frame. Schools who are ineligible for the study (as per Exclusion Criteria above) will be removed from the list, which will then be randomly allocated in a 1:1 ratio to either an intervention or control group by an independent Statistician using a computerised random number function.
Schools who are allocated to the intervention group will be mailed out a study information letter addressed to the school Principals, parent representatives and Canteen Managers outlining along with an invitation to attend Canteen Manager Training. Phone call recruitment will follow one week later to answer any questions regarding participation and to request consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomly allocated in a 1:1 ratio to either an intervention or control group by an independent statistician using a computerised random number function.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Trial outcomes will be assessed by comparing between group differences at follow-up regarding: i) the proportion of schools with a canteen menu containing foods or beverages prohibited from regular sale (‘red’ or ‘banned’ items); and ii) the proportion of schools where healthy canteen items represent the majority (>50%) of products listed on the menu, under an intention to treat approach. Intervention effectiveness will be assessed using logistic regression models adjusting for baseline values and with all available data. Imputation will be used as part of sensitivity analysis including imputation of baseline values for schools not providing follow-up data. Based on previous recruitment experiences of the research team in this setting 80% of participating schools will be retained at follow-up. Assuming a prevalence of 15% at follow-up in the comparison group for both primary trial outcomes, the sample will be sufficient to detect an absolute difference of 32% with 80% power and an alpha of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/10/2014
Actual
3/11/2014
Date of last participant enrolment
Anticipated
14/11/2014
Actual
14/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
63
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290072 0
Government body
Name [1] 290072 0
Hunter New England Local Health District Population Health
Country [1] 290072 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District Population Health
Address
Locked Bag 10, Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 288764 0
None
Name [1] 288764 0
Address [1] 288764 0
Country [1] 288764 0
Other collaborator category [1] 278180 0
Individual
Name [1] 278180 0
Luke Wolfenden
Address [1] 278180 0
The University of Newcastle, Callaghan Campus, Newcastle NSW
Country [1] 278180 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291776 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 291776 0
Ethics committee country [1] 291776 0
Australia
Date submitted for ethics approval [1] 291776 0
Approval date [1] 291776 0
01/11/2012
Ethics approval number [1] 291776 0
06/07/26/4.04
Ethics committee name [2] 291777 0
NSW Department of Education and Communities SERAP
Ethics committee address [2] 291777 0
Ethics committee country [2] 291777 0
Australia
Date submitted for ethics approval [2] 291777 0
Approval date [2] 291777 0
11/06/2014
Ethics approval number [2] 291777 0
2012277

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

Contacts
Principal investigator
Name 51986 0
Ms Nicole Nathan
Address 51986 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 51986 0
Australia
Phone 51986 0
+61 2 4924 6257
Fax 51986 0
+61 2 4924 6215
Email 51986 0
[email protected]
Contact person for public queries
Name 51987 0
Nicole Nathan
Address 51987 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 51987 0
Australia
Phone 51987 0
+61 2 4924 6257
Fax 51987 0
+61 2 4924 6215
Email 51987 0
[email protected]
Contact person for scientific queries
Name 51988 0
Nicole Nathan
Address 51988 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 51988 0
Australia
Phone 51988 0
+61 2 4924 6257
Fax 51988 0
+61 2 4924 6215
Email 51988 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.