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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.
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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
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Secondary ID [1]
282082
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity Prevention
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Public Health- Health Promotion/ Education
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Diet and Nutrition- Obesity
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Condition category
Condition code
Public Health
288910
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0
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Health promotion/education
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Diet and Nutrition
288911
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
286682
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Prevention
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Intervention code [2]
286683
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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The proportion of schools with a canteen menu containing foods or beverages prohibited (‘red’ and ‘banned’ items) under the Fresh Tastes @ School policy
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Assessment method [1]
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Timepoint [1]
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Baseline and 12 months later
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Primary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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Baseline and 12 months later
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Baseline and 12 months later
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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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/07/2013
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Actual
16/07/2013
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Date of last participant enrolment
Anticipated
5/08/2013
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Actual
20/09/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
70
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Accrual to date
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Final
70
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
6469
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2259 - Wyee
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Recruitment postcode(s) [2]
6470
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2264 - Bonnells Bay
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Recruitment postcode(s) [3]
6471
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2265 - Cooranbong
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Recruitment postcode(s) [4]
6472
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2267 - Wangi Wangi
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Recruitment postcode(s) [5]
6473
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2278 - Barnsley
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Recruitment postcode(s) [6]
6474
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2280 - Belmont
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Recruitment postcode(s) [7]
6475
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2281 - Blacksmiths
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Recruitment postcode(s) [8]
6476
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2282 - Warners Bay
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Recruitment postcode(s) [9]
6477
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2283 - Arcadia Vale
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Recruitment postcode(s) [10]
6478
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2284 - Argenton
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Recruitment postcode(s) [11]
6479
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2285 - Cardiff
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Recruitment postcode(s) [12]
6481
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2286 - West Wallsend
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Recruitment postcode(s) [13]
6482
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2287 - Elermore Vale
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Recruitment postcode(s) [14]
6483
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2289 - Adamstown
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Recruitment postcode(s) [15]
6484
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2290 - Charlestown
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Recruitment postcode(s) [16]
6485
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2291 - Merewether
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Recruitment postcode(s) [17]
6486
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2292 - Broadmeadow
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Recruitment postcode(s) [18]
6487
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2293 - Wickham
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Recruitment postcode(s) [19]
6488
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2295 - Stockton
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Recruitment postcode(s) [20]
6489
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2297 - Tighes Hill
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Recruitment postcode(s) [21]
6490
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2298 - Waratah
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Recruitment postcode(s) [22]
6491
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2299 - Jesmond
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Recruitment postcode(s) [23]
6492
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2300 - Newcastle
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Recruitment postcode(s) [24]
6493
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2303 - Hamilton
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Recruitment postcode(s) [25]
6494
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2304 - Mayfield
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Recruitment postcode(s) [26]
6495
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2305 - New Lambton
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Recruitment postcode(s) [27]
6496
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2306 - Windale
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Recruitment postcode(s) [28]
6497
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2307 - Shortland
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Recruitment postcode(s) [29]
6499
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2312 - Minimbah
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Recruitment postcode(s) [30]
6500
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2315 - Nelson Bay
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Recruitment postcode(s) [31]
6501
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2316 - Anna Bay
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Recruitment postcode(s) [32]
6502
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2317 - Salamander Bay
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Recruitment postcode(s) [33]
6503
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2318 - Medowie
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Recruitment postcode(s) [34]
6504
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2319 - Lemon Tree Passage
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Recruitment postcode(s) [35]
6505
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2320 - Maitland
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Recruitment postcode(s) [36]
6506
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2321 - Lochinvar
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Recruitment postcode(s) [37]
6507
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2322 - Beresfield
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Recruitment postcode(s) [38]
6508
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2323 - East Maitland
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Recruitment postcode(s) [39]
6509
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2324 - Raymond Terrace
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Recruitment postcode(s) [40]
6510
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2325 - Cessnock
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Recruitment postcode(s) [41]
6511
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2327 - Kurri Kurri
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Recruitment postcode(s) [42]
6512
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2333 - Muswellbrook
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Recruitment postcode(s) [43]
6513
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2334 - Greta
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Recruitment postcode(s) [44]
6514
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2335 - Branxton
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Recruitment postcode(s) [45]
6515
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2337 - Scone
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Recruitment postcode(s) [46]
6516
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2420 - Dungog
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Recruitment postcode(s) [47]
6521
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2289 - Garden Suburb
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Recruitment postcode(s) [48]
6522
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2282 - Eleebana
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Recruitment postcode(s) [49]
6523
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2290 - Whitebridge
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Recruitment postcode(s) [50]
6524
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2285 - Glendale
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
Government body
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Name
Hunter New England Population Health
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Address
Locked Bag 10
Wallsend NSW 2287
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
285648
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Country [1]
285648
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Hunter New England Research Ethics Committee
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Ethics committee address [1]
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Locked Bag No. 1
New Lambton NSW 2305
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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01/11/2012
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Ethics approval number [1]
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06/07/26/4.04
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Ethics committee name [2]
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NSW Department of Education and Communities SERAP
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Ethics committee address [2]
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Level 3
1 Oxford St
Darlinghurst NSW 2010
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
288919
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Approval date [2]
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14/12/2012
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Ethics approval number [2]
288919
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2012277
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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.
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Trial website
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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
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Public notes
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Contacts
Principal investigator
Name
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Dr Luke Wolfenden
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Address
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Locked Bag 10
Wallsend NSW 2287
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Country
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Australia
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Phone
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+61 2 4924 6567
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Fax
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+61 2 4924 6215
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Email
38346
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[email protected]
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Contact person for public queries
Name
38347
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Dr Luke Wolfenden
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Address
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Locked Bag 10
Wallsend NSW 2287
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Country
38347
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Australia
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Phone
38347
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+61 2 4924 6567
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Fax
38347
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+61 2 4924 6215
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Email
38347
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[email protected]
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Contact person for scientific queries
Name
38348
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Dr Luke Wolfenden
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Address
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Locked Bag 10
Wallsend NSW 2287
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Country
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Australia
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Phone
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+61 2 4924 6567
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Fax
38348
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+61 2 4924 6215
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
A randomised controlled trial of an intervention to increase the implementation of a healthy canteen policy in Australian primary schools: study protocol.
2014
https://dx.doi.org/10.1186/s13012-014-0147-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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