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Trial registered on ANZCTR


Registration number
ACTRN12613000311752
Ethics application status
Approved
Date submitted
6/03/2013
Date registered
20/03/2013
Date last updated
30/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Moving from policy to practice: A randomised trial of an implementation intervention to facilitate the adoption of a statewide healthy canteen policy in government primary schools.
Scientific title
Are school canteens that receive an intense intervention (consisting of face-to-face, telephone & print support) more likely than school canteens that receive no intervention to improve their school canteen menus that are consistent with Fresh Tastes @ School- the NSW Healthy Canteen Policy
Secondary ID [1] 282082 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity Prevention 288581 0
Public Health- Health Promotion/ Education
288582 0
Diet and Nutrition- Obesity
288583 0
Condition category
Condition code
Public Health 288910 288910 0 0
Health promotion/education
Diet and Nutrition 288911 288911 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include the following evidence based components:
1. Executive support from school principals and the school sector
2. Consensus processes to develop an implementation strategy.
3. Training – of canteen and school staff.
4. Tools and resources –including printed instructional materials, sample policies, planning templates, pricing guides, product lists of policy compliant menu items, and supplier contacts
5. Academic detailing– School canteen visits will be conducted to assist Canteen Managers assess and categorise menu items, to demonstrate canteen management, pricing and promotion strategies and to help problem solve barriers to policy implementation.
6. Recognition and promotion- promotion of schools making positive changes to their school canteen menus.
7. Performance monitoring and feedback– Project records will be used to compile quarterly feedback reports regarding adoption progress of intervention schools.
8. On-going support - Schools will be provided ongoing support contacts at least monthly (via email, telephone or in person) for 12 months to review progress, discuss deficits identified from self -monitoring; & facilitate problem solving.
Intervention code [1] 286682 0
Prevention
Intervention code [2] 286683 0
Behaviour
Comparator / control treatment
Usual support - consisting of standard teacher development opportunities regarding healthy eating and physical activity programs in schools which could include staff training or resources.
Control group
Active

Outcomes
Primary outcome [1] 289037 0
The proportion of schools with a canteen menu containing foods or beverages prohibited (‘red’ and ‘banned’ items) under the Fresh Tastes @ School policy
Timepoint [1] 289037 0
Baseline and 12 months later
Primary outcome [2] 289038 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.
Timepoint [2] 289038 0
Baseline and 12 months later
Secondary outcome [1] 301618 0
The mean total fat, sodium and energy per student, purchased at the school canteen
A count of all canteen products being sold during canteen service at recess and lunch times will be made. The total fat, sodium and energy of each item will be recorded based on information provided on product labels, or for fresh foods, estimates will be made by Dietitians using food data-bases.
Timepoint [1] 301618 0
Baseline and 12 months later

Eligibility
Key inclusion criteria
A random selection of Government primary schools within the Hunter Region of NSW, with a school canteen, will be invited to participate.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools from the Catholic or 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.

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)
Schools from the Catholic or 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomly allocated after baseline data collection in a 1:1 ratio to either an intervention or control group by an independent statistician using a computerised random number function. A block randomisation procedure will be employed to ensure group allocation is equal. The procedure will be stratified based on the socioeconomic area of school locality given evidence of an association between the socioeconomic area of the school and the trial outcome
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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A total of 35 intervention and 35 control schools will be recruited. Trial outcomes will be assessed by comparing between group differences at follow-up in the i) the proportion of schools with a canteen menu containing foods or beverages prohibited from regular sale (‘red’ and ‘banned’ items) and; ii) the proportion of schools where healthy canteen items represent the majority (>50%) of products listed on the menu using Chi-square tests under an intention to treat approach. Baseline values will be carried forward 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 30% with 80% power and an alpha of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6469 0
2259 - Wyee
Recruitment postcode(s) [2] 6470 0
2264 - Bonnells Bay
Recruitment postcode(s) [3] 6471 0
2265 - Cooranbong
Recruitment postcode(s) [4] 6472 0
2267 - Wangi Wangi
Recruitment postcode(s) [5] 6473 0
2278 - Barnsley
Recruitment postcode(s) [6] 6474 0
2280 - Belmont
Recruitment postcode(s) [7] 6475 0
2281 - Blacksmiths
Recruitment postcode(s) [8] 6522 0
2282 - Eleebana
Recruitment postcode(s) [9] 6476 0
2282 - Warners Bay
Recruitment postcode(s) [10] 6477 0
2283 - Arcadia Vale
Recruitment postcode(s) [11] 6478 0
2284 - Argenton
Recruitment postcode(s) [12] 6479 0
2285 - Cardiff
Recruitment postcode(s) [13] 6524 0
2285 - Glendale
Recruitment postcode(s) [14] 6481 0
2286 - West Wallsend
Recruitment postcode(s) [15] 6482 0
2287 - Elermore Vale
Recruitment postcode(s) [16] 6483 0
2289 - Adamstown
Recruitment postcode(s) [17] 6521 0
2289 - Garden Suburb
Recruitment postcode(s) [18] 6484 0
2290 - Charlestown
Recruitment postcode(s) [19] 6523 0
2290 - Whitebridge
Recruitment postcode(s) [20] 6485 0
2291 - Merewether
Recruitment postcode(s) [21] 6486 0
2292 - Broadmeadow
Recruitment postcode(s) [22] 6487 0
2293 - Wickham
Recruitment postcode(s) [23] 6488 0
2295 - Stockton
Recruitment postcode(s) [24] 6489 0
2297 - Tighes Hill
Recruitment postcode(s) [25] 6490 0
2298 - Waratah
Recruitment postcode(s) [26] 6491 0
2299 - Jesmond
Recruitment postcode(s) [27] 6492 0
2300 - Newcastle
Recruitment postcode(s) [28] 6493 0
2303 - Hamilton
Recruitment postcode(s) [29] 6494 0
2304 - Mayfield
Recruitment postcode(s) [30] 6495 0
2305 - New Lambton
Recruitment postcode(s) [31] 6496 0
2306 - Windale
Recruitment postcode(s) [32] 6497 0
2307 - Shortland
Recruitment postcode(s) [33] 6499 0
2312 - Minimbah
Recruitment postcode(s) [34] 6500 0
2315 - Nelson Bay
Recruitment postcode(s) [35] 6501 0
2316 - Anna Bay
Recruitment postcode(s) [36] 6502 0
2317 - Salamander Bay
Recruitment postcode(s) [37] 6503 0
2318 - Medowie
Recruitment postcode(s) [38] 6504 0
2319 - Lemon Tree Passage
Recruitment postcode(s) [39] 6505 0
2320 - Maitland
Recruitment postcode(s) [40] 6506 0
2321 - Lochinvar
Recruitment postcode(s) [41] 6507 0
2322 - Beresfield
Recruitment postcode(s) [42] 6508 0
2323 - East Maitland
Recruitment postcode(s) [43] 6509 0
2324 - Raymond Terrace
Recruitment postcode(s) [44] 6510 0
2325 - Cessnock
Recruitment postcode(s) [45] 6511 0
2327 - Kurri Kurri
Recruitment postcode(s) [46] 6512 0
2333 - Muswellbrook
Recruitment postcode(s) [47] 6513 0
2334 - Greta
Recruitment postcode(s) [48] 6514 0
2335 - Branxton
Recruitment postcode(s) [49] 6515 0
2337 - Scone
Recruitment postcode(s) [50] 6516 0
2420 - Dungog

Funding & Sponsors
Funding source category [1] 286859 0
Self funded/Unfunded
Name [1] 286859 0
Address [1] 286859 0
Country [1] 286859 0
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 285648 0
None
Name [1] 285648 0
Address [1] 285648 0
Country [1] 285648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288918 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 288918 0
Locked Bag No. 1
New Lambton NSW 2305
Ethics committee country [1] 288918 0
Australia
Date submitted for ethics approval [1] 288918 0
Approval date [1] 288918 0
01/11/2012
Ethics approval number [1] 288918 0
06/07/26/4.04
Ethics committee name [2] 288919 0
NSW Department of Education and Communities SERAP
Ethics committee address [2] 288919 0
Level 3
1 Oxford St
Darlinghurst NSW 2010
Ethics committee country [2] 288919 0
Australia
Date submitted for ethics approval [2] 288919 0
Approval date [2] 288919 0
14/12/2012
Ethics approval number [2] 288919 0
2012277

Summary
Brief summary
The adoption of healthy school canteen policies has been recommended as a strategy to prevent excessive weight gain. A number of jurisdictions in Australia and internationally have policies requiring school adoption of healthy canteen strategies. Despite this, internationally, schools have failed to adopt healthy canteen practices consistent with such policies. If the benefits of obesity prevention initiatives are to be realised, policies recommended to prevent overweight must be implemented. However, research measuring the effectiveness of interventions to facilitate widespread implementation of health promoting policies and practices in schools is limited. The aim of the research is to assess the effectiveness of a population wide implementation intervention in increasing canteen practices consistent with the mandatory NSW government healthy canteen policy (‘Fresh Tastes @ School’). The study will employ a randomised trial design. Seventy primary schools will be randomised to receive a 12 month intervention, or a no intervention comparison group. The effectiveness of the intervention will be determined by comparing post intervention differences between canteen menus audited by Dietitians in: i) the proportion of schools with a canteen menu containing foods or beverages restricted (‘red’ items) under the policy and; ii) the proportion of schools where healthy canteen items (‘green’) represent the majority (>50%) of products listed on the menu as recommended by the policy. The proposed research will be the first RCT of its kind, addresses a questions of particular policy relevance and will make an important contribution to reducing the burden of obesity.
Trial website
Trial related presentations / publications
Wolfenden L, Nathan N, Sutherland R, Williams C, Wiggers J, Gillham K, Bell AC, Freund M, Campbell L, Asmar M. A randomised controlled trial of a school-based intervention to increase the implementation of a healthy canteen policy in Australian primary schools: study protocol for the (PICNIC) trial. Implementation Science. 2014 vol 9; 147

Outcome papers are under review
Public notes

Contacts
Principal investigator
Name 38346 0
Dr Luke Wolfenden
Address 38346 0
Locked Bag 10
Wallsend NSW 2287
Country 38346 0
Australia
Phone 38346 0
+61 2 4924 6567
Fax 38346 0
+61 2 4924 6215
Email 38346 0
luke.wolfenden@hnehealth.nsw.gov.au
Contact person for public queries
Name 38347 0
Dr Luke Wolfenden
Address 38347 0
Locked Bag 10
Wallsend NSW 2287
Country 38347 0
Australia
Phone 38347 0
+61 2 4924 6567
Fax 38347 0
+61 2 4924 6215
Email 38347 0
luke.wolfenden@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 38348 0
Dr Luke Wolfenden
Address 38348 0
Locked Bag 10
Wallsend NSW 2287
Country 38348 0
Australia
Phone 38348 0
+61 2 4924 6567
Fax 38348 0
+61 2 4924 6215
Email 38348 0
luke.wolfenden@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary