Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000249550
Ethics application status
Approved
Date submitted
25/01/2024
Date registered
14/03/2024
Date last updated
14/03/2024
Date data sharing statement initially provided
14/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
'First Bite: A research program to help 3-5-year-old children eat more veggies.
Scientific title
First Bite: The effects of a multi-component Early Childhood Education and Care intervention on child vegetable intake..
Secondary ID [1] 311237 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Very poor child vegetable intake 332445 0
Condition category
Condition code
Public Health 329137 329137 0 0
Health promotion/education
Diet and Nutrition 329559 329559 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
“First Bite” is an multi-component intervention that primarily aims to improve vegetable intake of 3-5-years-old children in ECEC services and at home through targeted strategies to increase behavioural intentions and opportunities to eat vegetables. Intervention content includes: repeated exposure to vegetables, hands-on experiential learning, reinforcement of this learning at home and positive eating environment and educator practices within ECEC services. Proposed strategies will include:

1) training for educators on positive feeding practices and eating environments;
2) a daily vegetable break at ECEC services;
3) 8-week curricula including hands-on experiential learning activities at ECEC services focused on vegetables;
4) parent-targeted nutrition promotion messaging via ECEC services to reinforce experiential eating and to promote vegetable eating practices at home.
The multi-component program will engage children, parents and their carers through ECEC services.

1) Professional Development for educators
Practical training will be provided on best practices for supportive mealtime environments and educator feeding. A set of 6 x 15-minute modules will relate to feeding roles, role modelling, food refusal, pressure to eat and fussy eating geared towards promoting self-regulation of eating in children. The videos will be co-designed in partnership with the collaborating Local Health Districts (LHD) Early Years teams and the ECEC Advisory Group.

All video online training modules will be made available via Vimeo (online video platform) to the randomly selected ECEC intervention services an average of five weeks before First Bite commencement and are to be completed at their convenience at least two weeks prior to the start of the intervention period. ECEC services will be encouraged to view the videos during their staff meeting times, with ongoing access available to educators afterwards. If viewing is not possible during staff meeting times, Educators can complete training at another time. To track fidelity, a Director's discussion/reflection journal will accompany the videos. This will be used to guide the forward planning needed for First Bite implementation at individual ECECs level.

The discussion/reflection journal will also incorporate a minimalist planning checklist to identify the ways ECEC services plan to implement First Bite following each video presentation, and also to identify ways to decrease barriers in their specific services to aid full implementation of the program. A written manual will also be made available.

ECEC Directors and Educators will be asked to complete the First Bite pre/post surveys which will identify both ECEC curriculum and practice changes. Directors will be interviewed at a 6- month follow-up for their reflections on the program to determine if any First Bite intervention strategies have been continued within their service and how these strategies could be enhanced to facilitate long-term sustainability.

The control services will receive access to the resources after data collection following the 8- week First Bite program

2) Daily Vegetable Break
ECEC children will be given the opportunity to taste test different individual vegetables five to ten times, along with familiar vegetables as identified by the ECEC Advisory Group. A song will be sung at the beginning of the vegetable break to help solidify the positive messaging around eating vegetables. Children will be given the opportunity to explore their vegetable of the week through their senses of vision, sound, touch, taste and smell. Multiple tastings of the same vegetable are required for children to learn acceptance of new tastes and textures of vegetables.

The Veggie Break will occur between breakfast and lunch, separate to the morning tea and will last 30 minutes. Children will be involved with some vegetable preparation twice a week before sharing the vegetable platter. We encourage this activity to be conducted prior to morning tea. Ideally, this is to be the first group activity of the day following free play. Each ECEC will have its own curriculum time frames, so the morning time slot of the Veggie Break will be curriculum dependent.

Three vegetables will be provided weekly for the Veggie Break and will be a combination of one familiar vegetable, one unfamiliar vegetable and a vegetable of the week which high in carotenoid content. These will be served on a shared platter where children can choose vegetables and serve themselves.

Each intervention ECEC service will be visited by a researcher around weeks 4-5 of the program to assess the fidelity of implementation of the Veggie Break and other First Bite activities. A dedicated First Bite email and contact phone number will also be used to answer any queries regarding implementation. The ECEC Directors will also be asked to record in the discussion/reflection journal the First Bite activities that have been undertaken for that day, and any changes they have made to those activities to better fit their ECEC context.

3) Experiential learning activities for children
Healthy eating strategies will be incorporated into the ECEC curriculum to be delivered by ECEC Directors and Educators. The strategies will include the development of an 8-week immersive calendar of activities including storybooks, songs, gardening, art, sensory play and taste exposure experiences, and the delivery of the developed resources, activity and lesson plans to ECEC educators. The resources and guides will be included in a home pack (for parents), and an Educator pack (for ECEC services). These packs will also be available online and will include storybooks, and information to guide parents and educators to enhance interactions and engagement during the experiential learning activities. The discussion/reflection journal will be used to record the frequency of activities completed by the participating children including vegetable consumption at the ECEC service. This program will be finalised after consultation with the ECEC Advisory Group.

4) Resources for parents
The videos and text messages will be sent over an 8-week period to parents through the parent communications tool used by their ECEC (such as Kinderloop or Storypark apps, email or text messaging). The narrative style of the videos aligns closely with Narrative Persuasion, Social Cognitive Theory and the Trans-theoretical Model. Parents will be notified of the “veggie of the week” to be included, if possible, in their child’s lunch boxes and in home meals.

Videos will be 2-3 minutes in length and will be sent every Monday to parents via a Vimeo access link in the newsletter. Vimeo provides a analytics reports which will identify the number of views by parents. Topics span the Food Literacy model developed by Vidgen and Galleos and will include: preparing vegetables for meals, vegetable eating tips, role modelling, fussy eating, and encouraging healthy eating. Practical tips and advice to assist in packing a healthy lunchbox will be provided, which will be supplemented with e-newsletters and the vegetable of the week suggestion. Children's lunchbox contents will be observed at baseline and post-intervention to determine any changes in vegetable content. This will be done discreetly out of children's and parents' view if possible. A checklist of vegetables will be used to identify any vegetables changes in the lunchbox.

The videos and text messages will be sent over an 8-week period to parents through the
parent communications tool used by their ECEC (such as Kinderloop or Storypark apps, email or text messaging). The narrative style of the videos aligns closely with Narrative Persuasion, Social Cognitive Theory and the Trans-theoretical Model. Parents will be notified of the “veggie of the week” to be included, if possible, in their child’s lunch boxes and in home meals.

5. Intentional group teaching activity.
First Bite consists of a combination of group activities and individual activities. Intentional group reaching activities are structured activities that are set up by educators for children to engage with concurrently in a group. This differs to Individual activities, which involve activity stations that children can engage in or not, by themselves or with others.

A core Intentional teaching activity (15-20 min) will be conducted and repeated twice a week as most children attend ECEC two days a week, This activity involves children exploring the characteristics of two specified vegetables each week. Including

This includes a visual assessment of the vegetables, touching them, smelling them and discussing vegetable characteristics. Children will also discuss what sound the vegetable may make when being eaten and what it may taste like when licked. These communication skills regarding vegetable characteristics are encouraged to be carried over into the daily vegetable break and into the home. Taste investigation is by child’s choice only. Educators reiterate that taste changes over time, and discuss cultural differences in food preparation as an extension activity.

Three supporting activities will be conducted daily. These supporting activities encompass games, stories, singing, arts and crafts and include free play activity stations.

The Vegetable Break (20-30 minutes) will be implemented daily, with sensory assessment of vegetables completed twice a week during the Vegetable Break. Children will be given the equivalent of one serving of vegetables, consisting of three different vegetables (1 familiar, 1 unfamiliar, 1 with a high carotenoid level) to eat as they choose during this time.
Intervention code [1] 327693 0
Lifestyle
Intervention code [2] 327694 0
Behaviour
Comparator / control treatment
Active control is used. Those ECEC services randomised to the control group will continue with their usual face to face curriculum which does not include a vegetable focus and a daily Vegetable Break.
Control group
Active

Outcomes
Primary outcome [1] 336972 0
Efficacy of First Bite program on children's vegetable intake overall and during care, measured by a change in skin carotenoid levels
Timepoint [1] 336972 0
Baseline and program conclusion at 8 weeks
Secondary outcome [1] 430278 0
Efficacy of the mid-morning Vegetable Break to increase children's vegetable intake
Timepoint [1] 430278 0
Program conclusion at 8 weeks.
Secondary outcome [2] 430280 0
Efficacy of First Bite on children's preferences for vegetables
Timepoint [2] 430280 0
Baseline and program conclusion at 8 weeks.
Secondary outcome [3] 430281 0
Change in vegetable inclusion status in lunchbox contents from home
Timepoint [3] 430281 0
Baseline and program conclusion at 8 weeks.
Secondary outcome [4] 430282 0
Parent reported change in child eating habits
Timepoint [4] 430282 0
Post-intervention at 8 weeks, and 6-month follow up following program completion.
Secondary outcome [5] 430283 0
Process evaluation of the First Bite project from Educator feedback
Timepoint [5] 430283 0
Program completion at 8 weeks
Secondary outcome [6] 432169 0
Parent reported change in child interaction with vegetables
Timepoint [6] 432169 0
Post-intervention at 8 weeks, and 6 month follow up following program completion.
Secondary outcome [7] 432170 0
Parent confidence about child feeding
Timepoint [7] 432170 0
Post-intervention at 8 weeks, and 6 month follow up following program completion.
Secondary outcome [8] 432171 0
Food security
Timepoint [8] 432171 0
Post-intervention at 8 weeks, and 6 month follow up following program completion.
Secondary outcome [9] 432172 0
Parent acceptability of resource materials
Timepoint [9] 432172 0
Post-intervention at 8 weeks, and 6 month follow up following program completion.
Secondary outcome [10] 432173 0
Process evaluation from Directors feedback
Timepoint [10] 432173 0
Program completion at 8 weeks
Secondary outcome [11] 432174 0
Process evaluation from Director (6 months)
Timepoint [11] 432174 0
6-month follow up following program completion.

Eligibility
Key inclusion criteria
1) ECEC Services must serve priority populations as identified by SEIFA 1&2 codes by the Australian Bureau of Statistics and be Lunchbox services
2) ECEC Directors must consent on behalf of their organisation to be involved in the research.
ECEC Educators must have access to a computer to disseminate parent resources and use/own a mobile phone to access First Bite training modules.
3) Children must be aged 3-5-years and attend the recruited ECEC a minimum of two days a week, and have consent of their Parent/Guardian
4) Parent/Guardians must be able to read and understand English
Minimum age
3 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ECEC services that have representation on the ECEC Advisory Group

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. The research team members will be involved in all aspects of this research including both the data collection and statistical analysis. This is a PhD project and must therefore also align with the associated academic research requirements.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification of Lunchbox services by two LHDs for representative weighting of two ECEC services.
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
The efficacy of First Bite will be tested using an intention to treat approach. Statistical analyses will be conducted using SPSS, and inferential statistics will be calculated for carotenoid level changes, plate waste and lunchbox audits using linear/mixed model regression analysis. Results will also be triangulated for robust findings under the guidance of the Statistical Consulting Service. Child 'liking' of vegetables using Likert scoring will be analysed by generalised linear mixed model regression analysis. Clustering within ECECs will be accounted for in the analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2024
Actual
Date of last participant enrolment
Anticipated
11/10/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315494 0
Government body
Name [1] 315494 0
NSW Health - Prevention Research Support Program
Country [1] 315494 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave, Wollongong, NSW, 2522.
Country
Australia
Secondary sponsor category [1] 317597 0
None
Name [1] 317597 0
Address [1] 317597 0
Country [1] 317597 0
Other collaborator category [1] 282908 0
Government body
Name [1] 282908 0
Western Sydney Local Health District
Address [1] 282908 0
5 Fleet St, North Parramatta NSW 2151
Country [1] 282908 0
Australia
Other collaborator category [2] 282936 0
Government body
Name [2] 282936 0
Illawarra Shoalhaven Local Health District
Address [2] 282936 0
Country [2] 282936 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314397 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 314397 0
Lookout Road, New Lambton, NSW, 2305.
Ethics committee country [1] 314397 0
Australia
Date submitted for ethics approval [1] 314397 0
27/10/2023
Approval date [1] 314397 0
22/11/2023
Ethics approval number [1] 314397 0
2023/ETH02497

Summary
Brief summary
We aim to improve vegetable intake of 3-5 year old children in Early Child Education and Care (ECEC) services and at home through targeted strategies. These include a children's daily mid-morning vegetable break and experiential learning activities while in ECEC, parental resources and ECEC educator professional development support to support children's behavioural intentions and increase opportunities to eat vegetables. Efficacy will be primarily measured by change in skin carotenoid levels. Secondary outcomes include changes in child preferences for vegetables and vegetable provision by parents in lunchboxes. A process evaluation to assess the implementation fidelity of the program strategies will also be undertaken.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131438 0
A/Prof Bridget Kelly Gillott
Address 131438 0
Wollongong University, Building 29, Northfields Avenue, Wollongong, NSW, 2522
Country 131438 0
Australia
Phone 131438 0
+61 2 4221 3893
Fax 131438 0
Email 131438 0
bkelly@uow.edu.au
Contact person for public queries
Name 131439 0
A/Prof Bridget Kelly Gillott
Address 131439 0
Wollongong University, Building 29, Northfields Avenue, Wollongong, NSW, 2522
Country 131439 0
Australia
Phone 131439 0
+61 2 4221 3893
Fax 131439 0
Email 131439 0
bkelly@uow.edu.au
Contact person for scientific queries
Name 131440 0
A/Prof Bridget Kelly Gillott
Address 131440 0
Wololongong University, Building 29, Northfields Avenue, Wollongong, NSW, 2522
Country 131440 0
Australia
Phone 131440 0
+61 2 4221 3893
Fax 131440 0
Email 131440 0
bkelly@uow.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21319Clinical study report    To be published after research completion



Results publications and other study-related documents

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