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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]

Nil

Universal Trial Number (UTN)

Trial acronym

The CAFE Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity Prevention

Public Health- Health Promotion/ Education

Diet and Nutrition- Obesity

Condition category

Condition code

Public Health

Health promotion/education

Diet and Nutrition

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]

Behaviour

Intervention code [2]

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]

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]

Baseline and 12 months later

Primary outcome [2]

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]

Baseline and 12 months later

Secondary outcome [1]

Time to compliance - the number of days for a canteen to comply with Fresh Tastes @ School policy, assessed by a menu audit.

Timepoint [1]

The number of days from baseline until compliance, or 12 months post baseline, whichever comes first.

Secondary outcome [2]

Self reported measure of canteen profitability

Timepoint [2]

Baseline and 12 months later

Secondary outcome [3]

Proportion of menu items in each category (red, amber, green) under Fresh Tastes @ School policy, assessed by a menu audit.

Timepoint [3]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Government body

Name

Hunter New England Population Health

Address

Locked Bag 10
Wallsend NSW 2287

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Research Services 
Research Integrity Unit 
The Chancellery 
The University of Newcastle 
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/05/2013

Ethics approval number [1]

H-2008-0343

Ethics committee name [2]

NSW Department of Education and Communities State Education Research Approvals Process

Ethics committee address [2]

Level 3
1 Oxford St
Darlinghurst NSW 2010

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

14/12/2012

Ethics approval number [2]

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

Dr Christopher Williams

Address

Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287

Country

Australia

Phone

+61249246297

Fax

[email protected]

Contact person for public queries

Name

Christopher Williams

Address

Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287

Country

Australia

Phone

+61249246297

Fax

[email protected]

Contact person for scientific queries

Name

Christopher Williams

Address

Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287

Country

Australia

Phone

+61249246297

Fax

[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

Source	Title	Year of Publication	DOI
Embase	CAFE: A multicomponent audit and feedback intervention to improve implementation of healthy food policy in primary school canteens: Protocol of a randomised controlled trial.	2015	https://dx.doi.org/10.1136/bmjopen-2014-006969
Embase	CAFE: A multicomponent audit and feedback intervention to improve implementation of healthy food policy in primary school canteens: A randomised controlled trial.	2016	https://dx.doi.org/10.1186/s12966-016-0453-z
Embase	Mechanisms of implementing public health interventions: a pooled causal mediation analysis of randomised trials.	2018	https://dx.doi.org/10.1186/s13012-018-0734-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically