Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001301954
Ethics application status
Approved
Date submitted
25/09/2020
Date registered
1/12/2020
Date last updated
15/12/2021
Date data sharing statement initially provided
1/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of an 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
Secondary ID [1] 302397 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insufficient vegetable intake 319185 0
Condition category
Condition code
Diet and Nutrition 317153 317153 0 0
Other diet and nutrition disorders
Public Health 317154 317154 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 Phase will develop the three initiatives for increasing children’s vegetable intake in long day care which target changes to food provision via increasing vegetables on the menu, delivery of experiential and sensory curriculum activities and use of supportive feeding practices at mealtimes. The Optimisation Phase will assess the the independent and synergistic effects of the initiatives to identify the optimal initiative package. The Evaluation Phase (described in separate trial registration) will test the effectiveness of the final initiative package.

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, developed by dietitians, 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. There are currently no South Australian guidelines, therefore Victorian Menu Planning Guidelines will be used. 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 have 4 weeks to complete training, the menu assessment and revise their menu according to the recommendations provided before implementing the revised menu at their next menu change. The revised menu will be evaluated after 8 weeks. Completion of the online training and menu assessment will be monitored using website analytics and questionnaires conducted with cooks at 12-week follow up.

MEALTIME ENVIRONMENT
The mealtime environment initiative will support educators to use practices at mealtimes that promote children’s vegetable acceptance and intake. The initiative will aim to increase educator’s knowledge and skills to use feeding practices at mealtimes that will promote vegetable familiarisation via repeated exposure and opportunities to try vegetables. Educators will complete an interactive online training module (~45-55 minutes) developed by dietitians, 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. Educators will have 4 weeks to complete the training and will then apply the knowledge and strategies learnt during mealtimes over 8 weeks. Completion of the online training and use feeding practices at mealtimes will be monitored via questionnaires 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 was developed by dietitians, early years learning experts and sensory scientists. 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. Educators will have 4 weeks to prepare to teach and will then teach the curriculum over 8-weeks. Delivery of the curriculum will be evaluated via a detailed checklist at 12-week follow-up.
Intervention code [1] 318683 0
Behaviour
Intervention code [2] 318684 0
Lifestyle
Comparator / control treatment
Long day care centres will be assigned to eight experimental conditions resulting from the crossing of the three initiatives, each of which has two conditions (present versus not present), and reflecting all possible combinations of initiative components, including a no-initiative control condition. Centres allocated to the control condition will continue with their usual practice and will be offered access to intervention at the completion of follow-up data collection.
Control group
Active

Outcomes
Primary outcome [1] 325231 0
Children’s vegetable intake - measured using plate waste method
Timepoint [1] 325231 0
baseline, 12-week follow-up (post intervention)
Secondary outcome [1] 387279 0
Menu compliance with guidelines - measured by menu assessment against menu planning guidelines using menu assessment tool
Timepoint [1] 387279 0
Baseline, 12-week follow-up (post intervention)
Secondary outcome [2] 387280 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] 387280 0
Baseline and 12-week follow-up (post intervention)
Secondary outcome [3] 387281 0
Acceptability of training and resources - measured with a purpose-designed questionnaire using the LORI framework.
Timepoint [3] 387281 0
12-week follow-up (post intervention)
Secondary outcome [4] 387282 0
Initiative delivery (fidelity) - measured using website metrics and purpose designed questions evaluating reasons for non-completion
Timepoint [4] 387282 0
12-week follow-up (post intervention)
Secondary outcome [5] 387283 0
Initiative implementation (dose) - measure using purpose-design self-report questionnaire evaluating delivery of components of each initiative and reasons for non-implementation.
Timepoint [5] 387283 0
12-week follow-up (post intervention)
Secondary outcome [6] 387284 0
Contextual and individual factors influencing implementation of the food provision initiative by cooks (barriers & facilitators, beliefs about benefits & disadvantages, social influences, beliefs about capabilities) - measured using the Theoretical Domains Framework Questionnaire (TDFQ) for Cook's by Seward et al 2017.
Timepoint [6] 387284 0
12-week follow-up (post intervention)
Secondary outcome [7] 387285 0
Compatibility of food provision initiative with cook’s practice (part of regular practice, professional role to implement and intention to implement) - measured using the TDFQ for cooks (Seward et al 2017)
Timepoint [7] 387285 0
12-week follow-up (post intervention)
Secondary outcome [8] 388442 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 by Seward et al 2017.
Timepoint [8] 388442 0
Baseline and 12-week follow-up (post intervention)
Secondary outcome [9] 388443 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 by Seward et al 2017.
Timepoint [9] 388443 0
Baseline and 12-week follow-up (post intervention)
Secondary outcome [10] 388444 0
Contextual and individual factors influencing implementation of the mealtime environment initiative by educators (barriers & facilitators, beliefs about benefits & disadvantages, social influences, beliefs about capabilities) - measured using an adapted version of the TDFQ-Cooks (Seward et al 2017) to be developed for this study.
Timepoint [10] 388444 0
12-week follow-up (post intervention)
Secondary outcome [11] 388445 0
Contextual and individual factors influencing implementation of the curriculum initiative by educators (barriers & facilitators, beliefs about benefits & disadvantages, social influences, beliefs about capabilities) - measured using an adapted version of the TDFQ-Cooks (Seward et al 2017) to be developed for this study.
Timepoint [11] 388445 0
12-week follow-up (post intervention)
Secondary outcome [12] 388448 0
Compatibility of mealtime environment initiative with educator’s 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 [12] 388448 0
12-week follow-up (post intervention)
Secondary outcome [13] 388449 0
Compatibility of curriculum initiative with educator’s 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 [13] 388449 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 centres 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. Children with severe allergies or medical conditions that significantly affect their food intake and prevent them from consuming the standard centre menu.

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 be conducted off-site by a member of the research team not involved in the study 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. Random allocation of Centres will be done using computer number sequence generation (Excel), stratified by socioeconomic status (based on postcode) and size of long day care centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming attrition of 15% and an intra-class correlation coefficient of 0.1 for clustered data with 80% power and a two-sided a of 0.05, 576-690 children, or 72-86 participants for each of the eight experimental conditions, will allow detection of a small-moderate effect (d=0.31) on children’s vegetable intake. Recruitment of 32 centres, with 4 centres per condition, will provide the required sample size. A factorial experiment using repeated measure ANOVA models will test the effects of the three initiatives on the primary outcome. Initial models will test whether each initiative (provided versus not provided) had a significant effect on vegetable intake and subsequent models will test two and three-way interactions between initiative components. Analyses will control for covariates including child gender, age, and number of children at each timepoint. For secondary outcomes of impact, logistic regression and linear regression models will assess treatment effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/12/2020
Actual
18/01/2021
Date of last participant enrolment
Anticipated
9/04/2021
Actual
15/04/2021
Date of last data collection
Anticipated
30/07/2021
Actual
2/09/2021
Sample size
Target
576
Accrual to date
Final
681
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306820 0
Commercial sector/Industry
Name [1] 306820 0
Horticulture Innovation
Country [1] 306820 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] 307378 0
Government body
Name [1] 307378 0
CSIRO
Address [1] 307378 0
CSIRO - Health & Biosecurity Flagship SAHMRI Adelaide PO Box 10041 Adelaide SA 5000
Country [1] 307378 0
Australia
Secondary sponsor category [2] 307380 0
Government body
Name [2] 307380 0
Nutrition Australia (Victoria Division)
Address [2] 307380 0
118 Cardigan Street Carlton, Victoria 3053
Country [2] 307380 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306983 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 306983 0
Ethics committee country [1] 306983 0
Australia
Date submitted for ethics approval [1] 306983 0
04/05/2020
Approval date [1] 306983 0
20/08/2020
Ethics approval number [1] 306983 0
1873

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

Contacts
Principal investigator
Name 105650 0
Prof Rebecca Golley
Address 105650 0
Caring Futures Institute College of Nursing and Health Sciences GPO Box 2100 Adelaide, SA 5001
Country 105650 0
Australia
Phone 105650 0
+61 8 8201 5596
Fax 105650 0
Email 105650 0
[email protected]
Contact person for public queries
Name 105651 0
Rebecca Golley
Address 105651 0
Caring Futures Institute College of Nursing and Health Sciences GPO Box 2100 Adelaide, SA 5001
Country 105651 0
Australia
Phone 105651 0
+61 8 8201 5596
Fax 105651 0
Email 105651 0
[email protected]
Contact person for scientific queries
Name 105652 0
Rebecca Golley
Address 105652 0
Caring Futures Institute College of Nursing and Health Sciences GPO Box 2100 Adelaide, SA 5001
Country 105652 0
Australia
Phone 105652 0
+61 8201 5596
Fax 105652 0
Email 105652 0
[email protected]

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 ethics 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.