The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting healthy eating, active play and sustainability consciousness in early childhood curricula: Addressing the Ben10 (Trademark) problem.
Scientific title
Effect of early childhood curriculum interventions on pre-school children's knowledge about healthy eating, active play and sustainability consciousness.
Secondary ID [1] 284354 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 291512 0
Condition category
Condition code
Diet and Nutrition 291881 291881 0 0
Public Health 291925 291925 0 0
Health promotion/education

Study type
Description of intervention(s) / exposure
Pre-school teachers to develop a curriculum intervention that integrates content knowledge about healthy eating, active play and sustainability consciousness. Each teacher’s curriculum intervention will be workshopped to ensure they have included the following components: 1) implementing the interventions over a period of 3-4 weeks to build a solid portfolio of experiences and strong base for children’s discussions; 2) implementing the interventions in the morning when the children are most cognitively alert; 3) combining both whole group and small group experiences and discussions; 4) using ‘real world’ props/resources, such as cereal boxes, McDonald’s Happy Meal (Trademark) boxes and toys and merchandise; and 5) maintaining assessment records of children’s learning using Learning Stories, observation and documentation. Teachers will be provided with an ‘Intervention Implementation Checklist’ and asked to record all components/elements associated with their curriculum interventions including: date, time, and duration of the intervention; the number of times the intervention or iterations of the intervention were implemented; Early Years Learning Framework Learning Outcomes aligned with the intervention; complete description of the intervention (including any resources/props used) and examples of any approaches to assessing children’s learning used in relation to the intervention. A booster session of 1 day duration, will be conducted 6 weeks after teachers implement their curriculum interventions whereby children will be exposed to an abridged version of the intervention.
Intervention code [1] 289082 0
Comparator / control treatment
The wait-list control group children will receive ‘usual care’, that is, their usual teaching and learning experiences as designed by participating educators. Qualitative and quantitative measures will be administered at the same time points as the intervention group. The teachers and children in this group will be offered the intervention at 7 months post baseline assessment.
Control group

Primary outcome [1] 291801 0
Children’s knowledge about healthy eating, active play and the sustainability consequences of their food and toy selections.
Timepoint [1] 291801 0
Semi-structured interview with children at baseline, the end of the intervention and 6 months post intervention.
Secondary outcome [1] 307581 0
Composite secondary outcomes consisting of children’s food preferences, digital media viewing and physical activity habits.
Timepoint [1] 307581 0
Eating and Physical Activity Questionnaire (EPAQ) completed by parents at baseline, the end of the intervention and 6 months post intervention.

Key inclusion criteria
Children aged 4-5 year old who attend preschool together with their English speaking parents. The children will be in their final year of preschool.
Minimum age
4 Years
Maximum age
5 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Children not aged 4-5 years.
Children not attending preschool programs.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on age of child and preschool attendance.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We calculated the sample size necessary to detect a clinically meaningful difference in vegetable consumption, significant at the 0.05 level, with a power of 0.8; this calculation resulted in a sample of 150 children in each group. Making a prudent allowance for attrition of 20% (based on our previous research with preschool children and their parents), the adjusted number per treatment condition is 180. A total of 360 4 year old children will therefore be recruited. This sample size is also sufficient to detect medium effect sizes in both the primary and secondary measures with a power of .8 at a is equal to 0.05 (Cohen, 1992). Our formative work indicated a potential 11% attrition rate. Making a prudent allowance for attrition of up to 20%, 360 4-5 year old children and their parents will therefore be recruited and the adjusted number of preschools per study arm is likely to be 18 (i.e. a total of 36 kindergartens in 18 pairs).
Baseline quantitative data (collected from parents) will be secured prior to treatment allocation, missing values will be scrutinized to check for non-random distribution and primary analyses will be executed twice: once using observed data, and once using multiple imputations under multivariate normal assumptions, so that all participants will be analysed in their allocated condition. Analyses of variance (with corrections for potential clustering effects of individuals within childcare centres) will test the between group differences in the primary outcome measure (children’s knowledge about healthy eating, active play and the sustainability consequences of their food and toy selections; interview data will be quantified, after each child’s interview has been transcribed, for the analyses) and the secondary outcome measures (child eating and activity habits) at each assessment time point and across time points for the children. The teachers’ qualitative interviews 6 months post intervention will be analysed using elements of phenomenology and thematic content analysis.

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 288993 0
Government body
Name [1] 288993 0
Australian Research Council
Country [1] 288993 0
Primary sponsor type
Deakin University
221 Burwood Highway
Victoria 3125
Secondary sponsor category [1] 287672 0
Name [1] 287672 0
Australian Catholic University
Address [1] 287672 0
115 Victoria Parade
Fitzroy Victoria 3065
Country [1] 287672 0
Secondary sponsor category [2] 287673 0
Name [2] 287673 0
Southern Cross University
Address [2] 287673 0
Military Road
East Lismore NSW 2480
Country [2] 287673 0

Ethics approval
Ethics application status
Ethics committee name [1] 290802 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 290802 0
221 Burwood Highway
Victoria 3125
Ethics committee country [1] 290802 0
Date submitted for ethics approval [1] 290802 0
Approval date [1] 290802 0
Ethics approval number [1] 290802 0

Brief summary
This paper details the research protocol for a study funded by the Australian Research Council. An integrated approach towards helping young children respond to the significant pressures of ‘360 degree marketing’ on their food choices, levels of active play, and sustainability consciousness via the early childhood curriculum is lacking. The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children’s knowledge about healthy eating, active play and the sustainability consequences of their toy food and toy selections.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 47330 0
Prof Helen Skouteris
Address 47330 0
Deakin University
221 Burwood Highway
Victoria 3125
Country 47330 0
Phone 47330 0
+61 03 9251 7699
Fax 47330 0
Email 47330 0
Contact person for public queries
Name 47331 0
Prof Helen Skouteris
Address 47331 0
Deakin University
221 Burwood Highway
Victoria 3125
Country 47331 0
Phone 47331 0
+61 03 9251 7699
Fax 47331 0
Email 47331 0
Contact person for scientific queries
Name 47332 0
Prof Helen Skouteris
Address 47332 0
Deakin University
221 Burwood Highway
Victoria 3125
Country 47332 0
Phone 47332 0
+61 03 9251 7699
Fax 47332 0
Email 47332 0

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided
Current supporting documents:

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePromoting healthy eating, active play and sustainability consciousness in early childhood curricula, addressing the Ben10TM problem: a randomised control trial.2014