Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001125718
Ethics application status
Approved
Date submitted
4/10/2013
Date registered
9/10/2013
Date last updated
8/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of adding healthier food options to fast food menus on parent food selection for themselves and their child.
Scientific title
A randomised controlled trial assessing the effects of adding healthier meal options to fast food menus on energy of intended purchases from hypothetical menus for parents and children.
Secondary ID [1] 283298 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intended energy purchase and consumption of parents and children 290181 0
Condition category
Condition code
Public Health 290567 290567 0 0
Health service research
Diet and Nutrition 290568 290568 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants (parents recruited form an existing database, with a child aged three to 12 years old) completed two scripted telephone interviews conducted by trained research assistants. The first interview was conducted from June to July 2011. Participants reported on a range of demographic and health behaviour data for themselves 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 this survey, participants were randomly allocated to one of two groups using a random number function embedded in the computer assisted telephone interviewing software in a 1:1 ratio without stratification. Based on group allocation, participants in this study were posted one of two 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. Depending on group allocation, participants received: Group 1 (Control). Fast food menu without healthy options. The standard menu contained 26 food and beverage items. Menu items names, description of ingredients and price was listed with each item. Group 2 (Intervention). Menu with the addition of healthier options and energy labelling. Participants in group 2 received the exact same menu as those in group 1, with the addition of 10 healthier food and beverage options. Participants were contacted approximately one to two weeks after receiving these menus and asked a series of questions assessing purchasing intentions and number of times intending to visit a fast food restaurant with the hypothetical menus, for both themselves and their child.
Intervention code [1] 288021 0
Behaviour
Comparator / control treatment
Group 1. Fast food menu without healthy options (control). The control group received a standard menu containing 26 food and beverage items.These items were grouped into three categories: beverages, main menu items and dessert. Menu item names and description of the ingredients were presented in a standard order on each menu. The measures for beverages (millilitres) and unit prices were available next to each item on the menu.
Control group
Active

Outcomes
Primary outcome [1] 290589 0
Total energy (in kilojoule) of intended fast food purchases for participants and their children
Timepoint [1] 290589 0
Calculated base on responses to second telephone interview
Primary outcome [2] 290590 0
Intention to visit a fast food restaurant with the hypothetical menus
Timepoint [2] 290590 0
Assessed during second telephone interview
Secondary outcome [1] 304993 0
None
Timepoint [1] 304993 0
None

Eligibility
Key inclusion criteria
Eligible participants include English speaking parents of children aged between three and 12 years residing in the Hunter New England region of New South Wales, Australia.
Minimum age
18 Years
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)
Parents were recruited via an existing research cohort which had been established as part of a random household Child Health Telephone Survey. A randomly selected sample of parents from this cohort who indicated they were willing to be contacted for future healthy surveys, were telephoned by a research assistant, assessed for eligibility, and those eligible, invited to participate in the study.

Consenting participants were unaware of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a random number function embedded within the first telephone interview, consenting participants will be randomly allocated in 1:1 ratio without stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
2/06/2011
Date of last participant enrolment
Anticipated
Actual
21/07/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
246
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288034 0
University
Name [1] 288034 0
University of Newcastle
Country [1] 288034 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10, WALLSEND NSW 2287
Country
Australia
Secondary sponsor category [1] 286756 0
None
Name [1] 286756 0
Nil
Address [1] 286756 0
Country [1] 286756 0
Other collaborator category [1] 277639 0
Individual
Name [1] 277639 0
Dr Luke Wolfenden
Address [1] 277639 0
Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2287
Country [1] 277639 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 43258 0
Ms Sze Lin Yoong
Address 43258 0
c/o Hunter New England Population Health Locked Bag 10 WALLSEND NSW 2287
Country 43258 0
Australia
Phone 43258 0
+612 49246413
Fax 43258 0
Email 43258 0
[email protected]
Contact person for public queries
Name 43259 0
Sze Lin Yoong
Address 43259 0
c/o Hunter New England Population Health Locked Bag 10 WALLSEND NSW 2287
Country 43259 0
Australia
Phone 43259 0
+612 49246413
Fax 43259 0
Email 43259 0
[email protected]
Contact person for scientific queries
Name 43260 0
Sze Lin Yoong
Address 43260 0
c/o Hunter New England Population Health Locked Bag 10 WALLSEND NSW 2287
Country 43260 0
Australia
Phone 43260 0
+612 49246413
Fax 43260 0
Email 43260 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.