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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
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
Secondary ID [1] 302717 0
None
Universal Trial Number (UTN)
Trial acronym
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.

Health condition
Health condition(s) or problem(s) studied:
Insufficient vegetable intake 319634 0
Condition category
Condition code
Diet and Nutrition 317573 317573 0 0
Other diet and nutrition disorders
Public Health 317574 317574 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 318995 0
Behaviour
Intervention code [2] 318996 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 325614 0
Usual vegetable intake in care over past month - measured using the vegetable items of the Short Food Survey for Early Childhood Education and Care
Timepoint [1] 325614 0
Baseline, 12-week follow-up (post intervention)
Secondary outcome [1] 388573 0
Menu compliance with guidelines (food groups) - measured by menu assessment against the Victorian Menu Planning Guidelines using online menu assessment tool
Timepoint [1] 388573 0
Baseline, 12-week follow-up (post intervention)
Secondary outcome [2] 388574 0
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.
Timepoint [2] 388574 0
Baseline and 12-week follow-up (post intervention)
Secondary outcome [3] 388575 0
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)
Timepoint [3] 388575 0
Baseline and 12-week follow-up (post intervention)
Secondary outcome [4] 388576 0
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)
Timepoint [4] 388576 0
Baseline and 12-week follow-up (post intervention)
Secondary outcome [5] 388580 0
Proportion of long day care centres in state participating (reach) - determined from study records and ACECQA data
Timepoint [5] 388580 0
Baseline and 12-week follow-up (post intervention)
Secondary outcome [6] 388581 0
Representativeness of centres (adoption) - centre (registration) baseline questionnaire
Timepoint [6] 388581 0
Baseline and 12-week follow-up (post intervention)
Secondary outcome [7] 388582 0
Initiative delivery (fidelity) - measured using website metrics
Timepoint [7] 388582 0
12-week follow-up (post intervention)
Secondary outcome [8] 388583 0
Initiative implementation (dose) - measured using purpose-design self-report questionnaire evaluating delivery of components of each initiative and reasons for non-implementation.
Timepoint [8] 388583 0
12-week follow-up (post intervention)
Secondary outcome [9] 388584 0
Acceptability of initiative package - measured using purpose designed questionnaire
Timepoint [9] 388584 0
12-week follow-up (post intervention)
Secondary outcome [10] 388585 0
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
Timepoint [10] 388585 0
12-week follow-up (post intervention)

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.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2022
Actual
Date of last participant enrolment
Anticipated
29/04/2022
Actual
Date of last data collection
Anticipated
12/08/2022
Actual
Sample size
Target
284
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC

Funding & Sponsors
Funding source category [1] 307120 0
Commercial sector/Industry
Name [1] 307120 0
Horticulture Innovation
Country [1] 307120 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
College of Nursing and Health Sciences
Flinders University
Sturt Road
Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 307693 0
Government body
Name [1] 307693 0
CSIRO
Address [1] 307693 0
CSIRO - Health & Biosecurity Flagship SAHMRI Adelaide PO Box 10041 Adelaide SA 5000
Country [1] 307693 0
Australia
Secondary sponsor category [2] 307733 0
Government body
Name [2] 307733 0
Nutrition Australia (Victoria Division)
Address [2] 307733 0
118 Cardigan Street Carlton, Victoria 3053
Country [2] 307733 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 307232 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 307232 0
Ethics committee country [1] 307232 0
Australia
Date submitted for ethics approval [1] 307232 0
04/10/2021
Approval date [1] 307232 0
Ethics approval number [1] 307232 0

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

Contacts
Principal investigator
Name 106494 0
Prof Rebecca Golley
Address 106494 0
Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 106494 0
Australia
Phone 106494 0
+61 8 8201 5596
Fax 106494 0
Email 106494 0
rebecca.golley@flinders.edu.au
Contact person for public queries
Name 106495 0
Dorota Zarnowiecki
Address 106495 0
Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 106495 0
Australia
Phone 106495 0
+61 8 8201 5519
Fax 106495 0
Email 106495 0
dorota.zarnowiecki@flinders.edu.au
Contact person for scientific queries
Name 106496 0
Dorota Zarnowiecki
Address 106496 0
Caring Futures Institute
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide, SA 5001
Country 106496 0
Australia
Phone 106496 0
+61 8 8201 5519
Fax 106496 0
Email 106496 0
dorota.zarnowiecki@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD has been approved under the research agreement for this study


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.