Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001036808
Ethics application status
Approved
Date submitted
26/09/2012
Date registered
27/09/2012
Date last updated
27/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of energy or traffic light labelling on parent and
child fast food selection
Scientific title
An investigation into the impact of energy or traffic light labelling on parent and child fast food selection as measured by intentional energy purchases from hypothetical fast food menus
Secondary ID [1] 281303 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child and adult intended energy consumption 287510 0
Condition category
Condition code
Diet and Nutrition 287838 287838 0 0
Obesity
Public Health 287845 287845 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study protocol required participants to complete two scripted telephone surveys conducted by a trained research assistant. A baseline survey conducted during June and July 2011 collected demographic and health behaviour data from parents and a child aged three to 12 years in their household. Where parents had more than one child from age three to 12, the child with the most recent birthday was selected. Following completion of the baseline survey, participants were randomly allocated to one of three groups using a random number function embedded in the computer assisted telephone interviewing software in a 1:1:1 ratio without stratification. Based on group allocation, participants in this study were posted one of three hypothetical fast food menus. Menus were comprised of items selected from a variety of common fast food outlets in Australia. Generic descriptive names were provided for each food item to reduce any pre-conceived beliefs about existing branded fast food products. Groups were as follows

Group 1. Standard fast food menu (control). All items in this menu were included in subsequent menus. The standard menu contained 36 food and beverage items, including healthier options.

Group 2. Standard menu with energy labelling. This menu was identical to that provided to Group 1, with the addition of energy content information being displayed next to each menu item. Energy content was displayed in kilojoules (kJ).

Group 3. Standard menu with traffic light (sign-post) labelling. The menu items were identical to that provided to Groups 1 and 2, with the addition of a single coloured symbol (traffic light) placed next to each menu item. The single coloured symbol of red, amber, or green reflected the saturated fat, sugar, salt and energy content of each menu product adapted from criteria developed for school canteens in Australia

Energy content, volume measures and pricing were sourced from the Australian websites of fast food outlets from which the menu items had been sourced.

Participants answered a series of questions about these menus in the follow up survey, which was conducted on average 17 days after the completion of the baseline survey. The follow up interview contained questions about purchase intentions, awareness of labelling information and attitudes towards fast foods.
Intervention code [1] 285766 0
Behaviour
Comparator / control treatment
The control group recieved a standard fast food menu. All items in this menu were included in menus for other groups. The standard menu contained 36 food and beverage items, including healthier options. All menu items were grouped into three categories: beverages, main menu items and dessert items. Menu items as well as a description of the item’s ingredients were presented in a standard order on each menu.

The menu included volume measures for beverages (millilitres) and unit price sourced from existing fast food chain websites. This menu did not contain information regarding energy content, or any other indication of the nutritional value of each product.
Control group
Active

Outcomes
Primary outcome [1] 288058 0
Total energy of intended purchase
Timepoint [1] 288058 0
Calculated based on responses to follow-up telephone interview
Secondary outcome [1] 299351 0
Awareness and use of labelling information. This was assessed by asking participants whether they noticed any nutritional information on the menu, and if so, whether this information influenced their purchase for themselves, or for their children.
Timepoint [1] 299351 0
Calculated based on responses to follow-up telephone interview

Eligibility
Key inclusion criteria
English speaking parents of children aged between three and 12 years residing in the Hunter New England region of New South Wales, Australia, were eligible for participation in the current study
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited from an existing research cohort of parents established as part of a random household child health telephone survey. A research assistant telephoned randomly selected parents from the research cohort, assessed eligibility and invited study participation. They subsequently completed the baseline survey.

Following completion of the baseline survey, participants were randomly allocated to one of three groups. Participants were unaware of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly allocated to one of three groups using a random number function embedded in the computer assisted telephone interviewing software in a 1:1:1 ratio without stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
294
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286059 0
University
Name [1] 286059 0
University of Newcastle
Country [1] 286059 0
Australia
Primary sponsor type
Individual
Name
Pennie Gibbins
Address
c/o HNEPH
Locked Bag 10
WALLSEND NSW 2287
Country
Australia
Secondary sponsor category [1] 284879 0
Government body
Name [1] 284879 0
Hunter New England Population Health
Address [1] 284879 0
Locked Bag 10
WALLSEND NSW 2287
Country [1] 284879 0
Australia
Other collaborator category [1] 277095 0
Individual
Name [1] 277095 0
Luke Wolfenden
Address [1] 277095 0
c/o HNEPH
Locked Bag 10
WALLSEND NSW 2287
Country [1] 277095 0
Australia
Other collaborator category [2] 277096 0
Individual
Name [2] 277096 0
Kathy Chapman
Address [2] 277096 0
PO Box 572
Kings Cross NSW 1340
Country [2] 277096 0
Australia
Other collaborator category [3] 277097 0
Individual
Name [3] 277097 0
Clare Hughes
Address [3] 277097 0
PO Box 572
Kings Cross NSW 1340
Country [3] 277097 0
Australia
Other collaborator category [4] 277098 0
Individual
Name [4] 277098 0
Lyndal Wellard
Address [4] 277098 0
PO Box 572
Kings Cross NSW 1340
Country [4] 277098 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288113 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 288113 0
Ethics committee country [1] 288113 0
Australia
Date submitted for ethics approval [1] 288113 0
Approval date [1] 288113 0
27/09/2006
Ethics approval number [1] 288113 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 34757 0
Address 34757 0
Country 34757 0
Phone 34757 0
Fax 34757 0
Email 34757 0
Contact person for public queries
Name 18004 0
Pennie Dodds
Address 18004 0
c/o Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2287
Country 18004 0
Australia
Phone 18004 0
+612 49246235
Fax 18004 0
Email 18004 0
[email protected]
Contact person for scientific queries
Name 8932 0
Pennie Dodds
Address 8932 0
c/o Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2287
Country 8932 0
Australia
Phone 8932 0
+612 49246235
Fax 8932 0
Email 8932 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.