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Trial registered on ANZCTR
Registration number
ACTRN12620001323910p
Ethics application status
Not yet submitted
Date submitted
5/11/2020
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of an multi-component initiative package to promote children’s vegetable intake in child care
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Scientific title
Application of the Multiphase Optimization Strategy to develop a multi-component initiative package to promote children’s vegetable intake in childcare - Evaluation Phase
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Secondary ID [1]
302717
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
Linked study: ACTRN12620001301954
This study is the Evaluation phase of a research project using the Multiphase Optimisation Strategy to develop and test a multicomponent initiative package to increase children's vegetable intake in long day care. The linked study (ACTRN12620001301954) is the earlier Optimisation Phase of the project which will identify to optimum combination of initiatives to be included in the final initiative package.
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Health condition
Health condition(s) or problem(s) studied:
Insufficient vegetable intake
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Condition category
Condition code
Diet and Nutrition
317573
317573
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0
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Other diet and nutrition disorders
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Public Health
317574
317574
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The overall project will undertake the three phases of the Multiphase Optimisation Strategy (MOST) study design to develop and evaluate a multicomponent initiative package to increase children’s vegetable intake in long day care. The Preparation and Optimisation phases will develop and evaluate the initiative components. This trial registration describes the final Evaluation Phase study which will test the effectiveness of the multicomponent initiative package for increasing children’s vegetable intake in care. The initiative package will comprise initiatives supporting cooks to increase vegetable provision on the menu, and educators to deliver a vegetable-focused curriculum and use of supportive feeding practices at mealtimes for increasing vegetable intake. Centres will use the initiative package for the 12-week intervention period.
FOOD PROVISION: The food provision initiative will support cooks to increase the provision of vegetables on the menu across all eating occasions. Cooks will complete an online training module, use an online menu planning tool to review their menu and implement the revised menu. The training will take approximately 45-55 minutes to complete and covers menu planning, importance of healthy eating, implementing menu guidelines and overcoming common barriers. Cooks will use an automated online menu assessment tool to assess compliance of their menu with guidelines. Cooks will enter their current menu, recipes, and number of children for whom their menu caters and will receive an overview of compliance of the menu with guidelines for each food group. Recommendations by food group will be provided, identifying meal occasions (morning snack, lunch, and afternoon snack) and days where the menu needs to be revised the menu to meet guidelines. Cooks will be asked to complete the training, menu assessment, revise their menu according to provided recommendations within the first 4 weeks of the intervention period and then implement their revised menu. Completion of the online training and menu assessment will be monitored using website analytics at 12-week follow up.
MEALTIME ENVIRONMENT: The mealtime environment initiative will provide training to increase educator’s knowledge and skills for using practices at mealtimes that promote children’s vegetable acceptance and intake. Educators will complete an interactive online training module (~45-55 minutes) which includes topics about the role of the educator in fostering children’s vegetable knowledge and acceptance, how to create a supportive meal time environment, use of feeding practices, overcoming barriers related to food rejection and how to plan, implement and monitor a strategy to within their centre. The training module will promote strategies to increasing vegetable acceptance and intake within the context of creating a mealtime environment which is supportive for increasing overall healthy eating. Completion of the online training will be monitored using website analytics at 12-week follow-up.
CURRICULUM: The curriculum initiative will consist of a lesson package for educators that aims to provide opportunities for children to learn about, try and enjoy vegetables by increasing their exposure to a variety of familiar and unfamiliar vegetables. The initiative is based on experiential learning, sensory education, and insights on vegetable preference development in children. The curriculum will be adapted from the evidence-based Taste & Learn vegetable education curriculum for primary school children (aged 5-12 years) to be suitable for younger children and align with The Early Years Learning Framework. The curriculum will consist of a series of 16 short (~10-20min) lessons and hands-on activities delivered during intentional teaching time, a series of 16 snack time occasions where vegetables will be tasted, supporting resources and activities (e.g. reading corner, songs) and a group reward chart to track progress of vegetables tasted. Educators will be provided with written background information and lesson plans. Delivery of the curriculum will be evaluated via a detailed checklist at 12-week follow-up.
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Intervention code [1]
318995
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Behaviour
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Intervention code [2]
318996
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Lifestyle
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Comparator / control treatment
Centres allocated to the control condition will continue with their usual practice for 12 weeks and will be offered access to intervention at the completion of follow-up data collection.
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Control group
Active
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Outcomes
Primary outcome [1]
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Usual vegetable intake in care over past month - measured using the vegetable items of the Short Food Survey for Early Childhood Education and Care
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Assessment method [1]
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Timepoint [1]
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Baseline, 12-week follow-up (post intervention)
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Secondary outcome [1]
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Menu compliance with guidelines (food groups) - measured by menu assessment against the Victorian Menu Planning Guidelines using online menu assessment tool
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Assessment method [1]
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Timepoint [1]
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Baseline, 12-week follow-up (post intervention)
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Secondary outcome [2]
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Knowledge and skills of cooks for provision of menu aligning with guidelines. Measured using the knowledge and skills scales of the Theoretical Domains Framework Questionnaire (TDFQ) for cooks by Seward et al 2017.
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Assessment method [2]
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Timepoint [2]
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Baseline and 12-week follow-up (post intervention)
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Secondary outcome [3]
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Knowledge and skills of educators for use of feeding practices at mealtimes. Measured using the knowledge and skills scales of the Theoretical Domains Framework Questionnaire (TDFQ), adapted from the TDFQ for Cooks (Seward et al 2017)
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Assessment method [3]
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Timepoint [3]
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Baseline and 12-week follow-up (post intervention)
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Secondary outcome [4]
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Knowledge and skills of educators for delivery of curriculum. Measured using the knowledge and skills scales of the Theoretical Domains Framework Questionnaire (TDFQ), adapted from the TDFQ for Cooks (Seward et al 2017)
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Assessment method [4]
388576
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Timepoint [4]
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Baseline and 12-week follow-up (post intervention)
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Secondary outcome [5]
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Proportion of long day care centres in state participating (reach) - determined from study records and ACECQA data
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Assessment method [5]
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Timepoint [5]
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Baseline and 12-week follow-up (post intervention)
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Secondary outcome [6]
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Representativeness of centres (adoption) - centre (registration) baseline questionnaire
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Assessment method [6]
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Timepoint [6]
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Baseline and 12-week follow-up (post intervention)
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Secondary outcome [7]
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Initiative delivery (fidelity) - measured using website metrics
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Assessment method [7]
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Timepoint [7]
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12-week follow-up (post intervention)
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Secondary outcome [8]
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Initiative implementation (dose) - measured using purpose-design self-report questionnaire evaluating delivery of components of each initiative and reasons for non-implementation.
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Assessment method [8]
388583
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Timepoint [8]
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12-week follow-up (post intervention)
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Secondary outcome [9]
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Acceptability of initiative package - measured using purpose designed questionnaire
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Assessment method [9]
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Timepoint [9]
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12-week follow-up (post intervention)
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Secondary outcome [10]
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Compatibility of initiative package with practice (part of regular practice, professional role to implement and intention to implement) - measured using an adapted version of the TDFQ (Seward et al 2017) developed for this study
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Assessment method [10]
388585
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Timepoint [10]
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12-week follow-up (post intervention)
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Eligibility
Key inclusion criteria
Private (non-Government) long day care centres, operating for at least eight hours per weekday (Monday to Friday), preparing food onsite, serving lunch and two between-meal snacks each day and enrolling children aged two to five years. All cooks and educators working at participating long day care centre and who give consent will be eligible to participate.
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Minimum age
2
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Centres catering exclusively to children with special needs. Additionally, Centres that participated in the optimisation phase will be excluded. No exclusion criteria will be applied for children.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed. Allocation will be conducted after completion of baseline assessments.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be at the centre level. Centres will be randomised to intervention or waitlist control group using stratified randomisation based on centre location and socioeconomic status (using postcode to determine SEIFA index).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Sample size was determined based on the a-priori hypothesis of an increase of 0.5 serves of vegetables per day achieved by the optimised initiative package (estimated effect size of d=0.65). At this effect size, with power at 0.8, p=0.05 and ICC=0.1, a sample 284 children is needed. Estimating that approximately 20 children will be provided per centre, 20 long day care centres will need to be recruited.
For the primary outcome, linear mixed modelling will assess between group differences in vegetable intake at 12-week. The primary outcome will be analysed using intention-to-treat principles. Models will control for baseline intake and potential confounding factors (i.e. baseline differences between groups). For secondary outcomes of impact, logistic regression and linear regression models will assess treatment effects.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/01/2022
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Actual
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Date of last participant enrolment
Anticipated
29/04/2022
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Actual
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Date of last data collection
Anticipated
12/08/2022
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Actual
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Sample size
Target
284
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Funding & Sponsors
Funding source category [1]
307120
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Commercial sector/Industry
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Name [1]
307120
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Horticulture Innovation
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Address [1]
307120
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Level 5, 606 St Kilda Road, Melbourne, Victoria 3004
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Country [1]
307120
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
College of Nursing and Health Sciences
Flinders University
Sturt Road
Bedford Park, SA 5042
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Country
Australia
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Secondary sponsor category [1]
307693
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Government body
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Name [1]
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CSIRO
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Address [1]
307693
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CSIRO - Health & Biosecurity Flagship SAHMRI Adelaide PO Box 10041 Adelaide SA 5000
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Country [1]
307693
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Australia
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Secondary sponsor category [2]
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Government body
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Name [2]
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Nutrition Australia (Victoria Division)
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Address [2]
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118 Cardigan Street Carlton, Victoria 3053
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Country [2]
307733
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Flinders University Social and Behavioural Research Ethics Committee
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Ethics committee address [1]
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Flinders University Sturt Road, Bedford Park, South Australia, 5042
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Ethics committee country [1]
307232
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Australia
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Date submitted for ethics approval [1]
307232
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04/10/2021
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Approval date [1]
307232
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Ethics approval number [1]
307232
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Summary
Brief summary
The first five years of life is an important period for establishing children’s liking and intake of vegetables. About half of Australian children aged 2-5 years attend formal early childhood education and care, where they consume 40-60% of their daily food intake. Therefore, early care and education settings can play a pivotal role in shaping young children’s dietary intake and there is a need to better support early care settings to provide supportive environments for promoting vegetable intake. The aim of this study is to evaluate to effectiveness of a multi-component initiative package for increasing children’s vegetable intake in long day care. The multi-component initiative package will comprise initiatives developed and tested in an earlier study, which support cooks to provide more vegetables on the menu, provide training for educators to encourage children to taste and enjoy vegetables at mealtimes, and support educators to teach a sensory and experiential vegetable-focused curriculum.
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Trial website
www.vegkit.com.au
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Rebecca Golley
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Address
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Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide, SA 5001
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Country
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Australia
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Phone
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+61 8 8201 5596
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dorota Zarnowiecki
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Address
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Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide, SA 5001
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Country
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Australia
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Phone
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+61 8 8201 5519
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dorota Zarnowiecki
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Address
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Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide, SA 5001
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Country
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Australia
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Phone
106496
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+61 8 8201 5519
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No IPD has been approved under the research agreement for this study
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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.
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