Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000363684
Ethics application status
Approved
Date submitted
28/03/2014
Date registered
7/04/2014
Date last updated
7/04/2014
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
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
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
Obesity
Public Health 291925 291925 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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
Prevention
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children not aged 4-5 years.
Children not attending preschool programs.

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 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
1/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290802 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 290802 0
Ethics committee country [1] 290802 0
Australia
Date submitted for ethics approval [1] 290802 0
03/09/2013
Approval date [1] 290802 0
03/10/2013
Ethics approval number [1] 290802 0
2013-220

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

Contacts
Principal investigator
Name 47330 0
Prof Helen Skouteris
Address 47330 0
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country 47330 0
Australia
Phone 47330 0
+61 03 9251 7699
Fax 47330 0
Email 47330 0
[email protected]
Contact person for public queries
Name 47331 0
Helen Skouteris
Address 47331 0
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country 47331 0
Australia
Phone 47331 0
+61 03 9251 7699
Fax 47331 0
Email 47331 0
[email protected]
Contact person for scientific queries
Name 47332 0
Helen Skouteris
Address 47332 0
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country 47332 0
Australia
Phone 47332 0
+61 03 9251 7699
Fax 47332 0
Email 47332 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
EmbasePromoting healthy eating, active play and sustainability consciousness in early childhood curricula, addressing the Ben10TM problem: a randomised control trial.2014https://dx.doi.org/10.1186/1471-2458-14-548
N.B. These documents automatically identified may not have been verified by the study sponsor.