Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000543785
Ethics application status
Approved
Date submitted
13/05/2013
Date registered
15/05/2013
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Canteen Audit and Feedback Effectiveness study: A randomised controlled trial
Scientific title
Are school canteens that receive audit and feedback more likely than school canteens that receive no intervention to improve their school canteen menu to comply with the NSW Fresh Tastes @ School - Healthy Canteen Policy?
Secondary ID [1] 282478 0
Nil
Universal Trial Number (UTN)
Trial acronym
The CAFE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity Prevention 289103 0
Public Health- Health Promotion/ Education 289104 0
Diet and Nutrition- Obesity 289105 0
Condition category
Condition code
Public Health 289442 289442 0 0
Health promotion/education
Diet and Nutrition 289443 289443 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve an audit and feedback process consisting of an initial introductory contact with canteen managers, followed by: a menu audit, a written feedback report and at least one telephone feedback/support call. This menu audit and feedback process will be conducted once per term (approximately 3 months apart) for 1 year after baseline (i.e. 4 school terms).

The written feedback report will contain specific details about the compliance of schools menu with Fresh Tastes @ School policy. Feedback/support calls will involve discussion of the report and key areas required for improvement to comply with Fresh Tastes @ School policy.
Intervention code [1] 287127 0
Behaviour
Intervention code [2] 287128 0
Prevention
Comparator / control treatment
Usual support - consisting of standard teacher development opportunities (up to one per year and attended dependant on opportunity) regarding healthy eating and physical activity programs in schools. These development opportunities may include staff training about specific government policy (e.g. Live Life Well @ School, Fresh Tastes @ School, Crunch and Sip) and/or the provision of miscellaneous resources relating to such policy.
Control group
Active

Outcomes
Primary outcome [1] 289547 0
The proportion of schools with a canteen menu containing foods or beverages prohibited (‘red’ and ‘banned’ items) under the Fresh Tastes @ School policy, assessed by a menu audit.
Timepoint [1] 289547 0
Baseline and 12 months later
Primary outcome [2] 289548 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, assessed by a menu audit.
Timepoint [2] 289548 0
Baseline and 12 months later
Secondary outcome [1] 302710 0
Time to compliance - the number of days for a canteen to comply with Fresh Tastes @ School policy, assessed by a menu audit.
Timepoint [1] 302710 0
The number of days from baseline until compliance, or 12 months post baseline, whichever comes first.
Secondary outcome [2] 302761 0
Self reported measure of canteen profitability
Timepoint [2] 302761 0
Baseline and 12 months later
Secondary outcome [3] 302762 0
Proportion of menu items in each category (red, amber, green) under Fresh Tastes @ School policy, assessed by a menu audit.
Timepoint [3] 302762 0
Baseline and 12 months later

Eligibility
Key inclusion criteria
Primary schools with a school canteen located in the New England Region of NSW or in rural or remote communities of the Hunter Region of NSW, 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 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)
Eligible schools will be randomly allocated to either an intervention or control group in a 1:1 ratio by an investigator, not involved in data collection or intervention delivery, using a computer generated randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated a priori by an independent investigator using the random number function in EXCEL.
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
Primary outcomes will be assessed by comparing between group differences at follow-up using Chi-square tests under an intention to treat approach. A total of 36 schools in the intervention group and 36 in the control group will be sufficient to detect an absolute difference of 30% between groups with 80% power and an alpha of 0.05. This estimate is based on less than 25% (SD) of school menus in the control group compiling with Fresh Tastes @ School policy and accounts for up to 20% loss to follow up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2013
Actual
15/05/2013
Date of last participant enrolment
Anticipated
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
30/01/2015
Sample size
Target
72
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287258 0
Self funded/Unfunded
Name [1] 287258 0
Country [1] 287258 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] 286012 0
None
Name [1] 286012 0
Address [1] 286012 0
Country [1] 286012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289238 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 289238 0
Research Services
Research Integrity Unit
The Chancellery
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 289238 0
Australia
Date submitted for ethics approval [1] 289238 0
Approval date [1] 289238 0
07/05/2013
Ethics approval number [1] 289238 0
H-2008-0343
Ethics committee name [2] 289239 0
NSW Department of Education and Communities State Education Research Approvals Process
Ethics committee address [2] 289239 0
Level 3
1 Oxford St
Darlinghurst NSW 2010
Ethics committee country [2] 289239 0
Australia
Date submitted for ethics approval [2] 289239 0
Approval date [2] 289239 0
14/12/2012
Ethics approval number [2] 289239 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, many schools have not adopted healthy canteen practices consistent with mandated policies.

One reason why many schools are yet to adopt healthy canteen policy is that current interventions aiming to improve practice cannot feasibility be extended to large numbers of schools, in particular to those in rural and remote communities. A promising solution to support population wide practice change of school canteens is audit and feedback. However, currently no evaluation of audit and feedback has been conducted in this setting. The aim of this research is to assess the effectiveness of an audit and feedback intervention to increase the adoption of canteen practices consistent with the mandatory NSW government healthy canteen policy (‘Fresh Tastes @ School’).

Seventy-two primary schools that provide canteen services to students will be recruited to participate. Schools will be randomised to an intervention group receiving a 12 month audit and feedback intervention delivered via telephone and written report, or a no intervention comparison group. The effectiveness of the intervention will be determined by comparing post intervention differences between canteen menus audited by Dieticians 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 is the first evaluation of an audit and feedback intervention in primary schools. The study is of relevance to the efficient delivery of population wide services, particularly to those in rural and remote communities, aiming to reduce the burden of obesity.
Trial website
Trial related presentations / publications
Yoong SL, Nathan N, Wolfenden L, Wiggers J, Reilly K, Oldmeadow C, et al., 'CAFE: a multicomponent audit and feedback intervention to improve implementation of healthy food policy in primary school canteens: a randomised controlled trial', International Journal of Behavioral Nutrition and Physical Activity, (2016) 13:126 DOI 10.1186/s12966-016-0453-z
Public notes

Contacts
Principal investigator
Name 39922 0
Dr Christopher Williams
Address 39922 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 39922 0
Australia
Phone 39922 0
+61249246297
Fax 39922 0
Email 39922 0
christopher.m.williams@hnehealth.nsw.gov.au
Contact person for public queries
Name 39923 0
Dr Christopher Williams
Address 39923 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 39923 0
Australia
Phone 39923 0
+61249246297
Fax 39923 0
Email 39923 0
christopher.m.williams@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 39924 0
Dr Christopher Williams
Address 39924 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 39924 0
Australia
Phone 39924 0
+61249246297
Fax 39924 0
Email 39924 0
christopher.m.williams@hnehealth.nsw.gov.au

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
EmbaseCAFE: A multicomponent audit and feedback intervention to improve implementation of healthy food policy in primary school canteens: Protocol of a randomised controlled trial.2015https://dx.doi.org/10.1136/bmjopen-2014-006969
EmbaseMechanisms of implementing public health interventions: a pooled causal mediation analysis of randomised trials.2018https://dx.doi.org/10.1186/s13012-018-0734-9
EmbaseCAFE: A multicomponent audit and feedback intervention to improve implementation of healthy food policy in primary school canteens: A randomised controlled trial.2016https://dx.doi.org/10.1186/s12966-016-0453-z
N.B. These documents automatically identified may not have been verified by the study sponsor.