Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001313325
Ethics application status
Approved
Date submitted
8/09/2017
Date registered
13/09/2017
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring how children's food brand associations and food choice preferences are affected by exposures to food marketing within web-based games: a Public Health perspective
Scientific title
Exploring how children's food brand associations and food choice preferences are affected by exposures to food marketing within web-based games: a Public Health perspective
Secondary ID [1] 292787 0
Nil known
Universal Trial Number (UTN)
U1111-1201-7138
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Child Overweight and Obesity 304651 0
Unhealthy Diet 304652 0
Condition category
Condition code
Diet and Nutrition 303971 303971 0 0
Obesity
Public Health 303972 303972 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief summary: The harm that junk food marketing poses to children’s health has been acknowledged by leading health agencies, such as World Health Organization. Online marketing of foods to children is particularly pervasive, yet relatively little is known about how this may affect children’s food preferences. The purpose of this research is to explore how children respond to online food marketing. It will investigate the marketing techniques used in branded online games and explore how this influences what users subsequently choose to eat. Children (aged 7-12) will be required for a one-off visit of 25 minutes to complete some questionnaires, play a 4 minute online game, choose a snack from a selection of items and then have their height and weight measured. The results from the study will be used in a wider body of work (as part of an Australian Research Council project) which aims to inform future public policy decisions to further limit children’s exposure to unhealthy food marketing.

Sample Population/Setting: 150 Children aged 7-12 will be recruited across three sites. The study will be run by a Public Health PhD student and a research assistant from the School of Health and Society at the University of Wollongong. Firstly, we are collaborating with the University of Wollongong Spring Sports Camp to recruit from their pool of children who are attending the camp. The data will be collected in an activity room in the Illawarra Health and Medical Research Institute (IHMRI) at the University of Wollongong campus, within very close proximity to the Sports Camp. We aim to gather data from 60 people at this site. Peak Sports and Learning, a children’s care company that implement breakfast and after-school clubs at schools in the Illawarra have also agreed to collaborate with the study and we expect to get approximately 80 participants from these sites. We aim to get the remaining 20 participants by advertising the study for participants in the area to visit Early Start at the University of Wollongong to take part.

Experimental Design: The proposed study will use a between subjects design, with four conditions (3 experimental, 1 control). The participants will be randomly allocated to one of four conditions: 1) Control – game with no advertising, 2) Game with peripheral advert 3) Game with in-game economy, and 4) Game with YouTube advertisement in game. Condition one will have no branding at all. The condition two will have a rectangular advert for the food brand aligned underneath the game screen. Condition three will incorporate the food brand as a game piece for the participant to collect, and this item will be worth 15 points in the game, whereas a coin will be worth 1 point. Condition four will introduce a YouTube advertisement of the food brand when the character arrives at a door in the game. When they reach the door a YouTube video launches and they will watch an advert for the product, which will then close and reveal a ‘mystery level’. In this level the character is in space environment with plentiful coins which are worth 100 points.
The same brand will be ‘marketed’ to the participants in all experimental conditions and will not be advertised in the control. The chosen brand is from the U.K and should be unfamiliar to Australian children. An unfamiliar brand is the most appropriate because it can be used to explore the effect of priming in the absence of an existing brand attachment and it also means that the participants cannot purchase products from the brand after seeing the advertisements.

Materials/measures:
Game - The online game that will be used as the marketing platform for the study has been created for the study and tailored to the study’s exact specifications and requirements. Creating a game allowed us to manipulate several things such as the marketing techniques in the conditions and the time it is played for. It is a web-based side-scroller game, in which the player will have four minutes to help an alien named ‘Ziggy’ collect as many gold coins as they can. The alien ‘Ziggy’ has been kept gender neutral and the aim of the game is to mimic other popular online games, such as Mario Kart.

Food (snack) - The test brand is a lolly (sweet, U.K). Following the game, the participants will be presented with four foods in labelled opaque paper cups with lids so that the product is not visible. One of the available food options will be the test brand, and the other three foods will not have been present in the online game (another unfamiliar brand, unbranded lollies, and green grapes). The labels indicating the contents ensure that the children will choose based on the brand name, rather than by the look of the product inside. We did not want to have any brands available that the child already knew of, which is why the options are all unfamiliar or unbranded. Having two unfamiliar food brands, which only one of which was advertised, should show us whether the advertising had an effect on food choice. To avoid all of the snacks being consumed and to induce a choice component, the children will only be allowed to choose one of the snacks available to them. The chosen food will be weighed before and after consumption and will be measured in grams and kilojoules. The snack that is chosen will also be measured by how often it is chosen between conditions.

Anthropometric measures - The children will have their height and weight measured for calculating their BMI.

Questionnaires – 1) Vas Hunger Scale 2) Logo Recognition Questionnaire (implemented pre and post-game) 3) Usual online game playing behaviours/usual lolly consumption questionnaire


Procedure:
1. The participant will complete a VAS Hunger scale and a Logo Recognition Questionnaire.
2. The participant will have been randomly assigned to a game condition, and will play the game for four minutes until the timer runs down to zero.
3. The participant will then be told they are allowed to choose one snack to eat at their desk from four choices of packaged and labelled snacks. They are allowed to eat as much or as little of the snack as they would like and we continue when the child says that they are finished.
4. After this, the participant will complete a questionnaire about usual online game playing/lolly consumption behaviours and complete the Logo Recognition questionnaire again.
5. Finally, the participant will have their height and weight measured.
Intervention code [1] 299081 0
Behaviour
Comparator / control treatment
The study is a between subjects design with four conditions, 3 experimental and 1 control. In the control condition, which children will randomly be allocated to, the same protocol is followed except that the child will play the online game with no branding or advertising in it.
Control group
Active

Outcomes
Primary outcome [1] 303324 0
Children's chosen snack after exposure to game
- We will measure which snack each child in each condition decided to choose to eat after playing the game.
Timepoint [1] 303324 0
This is measured immediately after each child has participated.
Primary outcome [2] 303334 0
Amount eaten of chosen snack
- This will be weighed pre and post consumption to calculate the amount eaten (in grams and kilocalories)
Timepoint [2] 303334 0
This is measured at the end of the study session for each participant.
Secondary outcome [1] 338627 0
Children's Height and Weight
- Each child's height and weight will be measured using a stadiometer (cm) and scales (kg).
- Height and weight will be measured twice and an average will be taken, though children who do not want to be measured will not be coerced to do so.
- Children's Body Mass Index (BMI) will be calculated from this information so the children can be classified as children with underweight, normal weight, overweight and obesity.
Timepoint [1] 338627 0
These measurements are taken for each child during their 25 minutes of participation.
Secondary outcome [2] 338628 0
Children's Logo Recognition of Test Food Brand
- Each child will complete a Logo Recognition questionnaire pre and post playing the game.
- The 9-item questionnaire is adapted from a Logo Recognition questionnaire that has been previously designed for/used with this age group.
- We are measuring if the children recognise the test brand before they start the game
- We also want to know if after playing the game, dependent on condition, if the children then indicate that they subsequently recognise the test brand not.
Timepoint [2] 338628 0
This is measured pre and post game exposure during the child's 25 minute participation.

Eligibility
Key inclusion criteria
Children aged 7 to 12 years are eligible to participate, as long as their parents/legal guardians have provided written consent and the child themselves provide verbal consent at the time of the interview. Children must not have a strong aversion or allergy to Gummy Lollies and Grapes.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children are considered to be ineligible to participate if they have a strong aversion to or an allergy to the study foods (Gummy Lollies and Grapes). Participants who can not supply informed written consent will not be taken.

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)
Allocation to all conditions will be concealed using central randomisation by a computer (Microsoft Excel randomisation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be allocated into conditions using simple randomisation - using a randomisation table created by Microsoft Excel on a computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Within subjects design of 4 conditions (1 control and 3 experimental conditions). All conditions run the same protocol except the version of game played.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size (80% power) with a significance of 0.05, was based on published data from a similar study (Folkvord, 2016) using the differences in kilojoules reported between game conditions. This calculation indicated that N=136 would be appropriate. We aim to recruit N=150 to allow for attrition.
The data will be analysed using logistic regression to compare the percentage of children choosing the test brand across the conditions. Data will also be analysed using linear regression to assess the amount of the snack consumed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2017
Actual
25/09/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
28/11/2017
Date of last data collection
Anticipated
1/12/2017
Actual
30/11/2017
Sample size
Target
150
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 17340 0
2522 - University Of Wollongong
Recruitment postcode(s) [2] 17341 0
2527 - Albion Park
Recruitment postcode(s) [3] 17342 0
2530 - Dapto
Recruitment postcode(s) [4] 17343 0
2529 - Oak Flats
Recruitment postcode(s) [5] 17344 0
2529 - Shellharbour

Funding & Sponsors
Funding source category [1] 297419 0
Government body
Name [1] 297419 0
Australian Research Council
Country [1] 297419 0
Australia
Funding source category [2] 297465 0
Charities/Societies/Foundations
Name [2] 297465 0
Cancer Council NSW
Country [2] 297465 0
Australia
Primary sponsor type
Individual
Name
Dr Bridget Kelly
Address
University of Wollongong,
School of Health and Society,
Northfields Avenue,
Wollongong, NSW 2522
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 296412 0
None
Name [1] 296412 0
N/A
Address [1] 296412 0
N/A
Country [1] 296412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298525 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 298525 0
Ethics committee country [1] 298525 0
Australia
Date submitted for ethics approval [1] 298525 0
29/06/2017
Approval date [1] 298525 0
08/08/2017
Ethics approval number [1] 298525 0
2017/311

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2028 2028 0 0
/AnzctrAttachments/373574-Ethics Approval Letter.pdf (Ethics approval)
Attachments [2] 2029 2029 0 0
/AnzctrAttachments/373574-Flow Chart of Study Protocol.pdf (Protocol)

Contacts
Principal investigator
Name 77354 0
Dr Bridget Kelly
Address 77354 0
Early Start
School of Health and Society
University of Wollongong
Northfields Avenue
Wollongong 2522
NSW
Country 77354 0
Australia
Phone 77354 0
+61 2 4221 3893
Fax 77354 0
Email 77354 0
[email protected]
Contact person for public queries
Name 77355 0
Rachel Smith
Address 77355 0
Early Start
School of Health and Society
University of Wollongong
Northfields Avenue
Wollongong 2522
NSW
Country 77355 0
Australia
Phone 77355 0
+61 481234745
Fax 77355 0
Email 77355 0
[email protected]
Contact person for scientific queries
Name 77356 0
Rachel Smith
Address 77356 0
Early Start
School of Health and Society
University of Wollongong
Northfields Avenue
Wollongong 2522
NSW
Country 77356 0
Australia
Phone 77356 0
+61 481234745
Fax 77356 0
Email 77356 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
SourceTitleYear of PublicationDOI
EmbaseAdvertising Placement in Digital Game Design Influences Children's Choices of Advertised Snacks: A Randomized Trial.2020https://dx.doi.org/10.1016/j.jand.2019.07.017
N.B. These documents automatically identified may not have been verified by the study sponsor.