Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000296932
Ethics application status
Approved
Date submitted
21/02/2020
Date registered
4/03/2020
Date last updated
2/02/2022
Date data sharing statement initially provided
4/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting cooks to provide healthy meals in childcare
Scientific title
Effect of a pilot menu box delivery service direct to long day care settings on children's vegetable intake
Secondary ID [1] 300542 0
Hort Innovation Project Code: VG16064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insufficient vegetable intake 316344 0
Poor dietary intake 316345 0
Condition category
Condition code
Diet and Nutrition 314601 314601 0 0
Other diet and nutrition disorders
Public Health 314602 314602 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MENU BOX DELIVERY

This study will pilot the delivery of menu boxes direct to long day care centres over a period of 8-weeks (2 x 4-week menu cycles). A 4-week menu will be developed by dietitians that meets the Victorian Menu Planning Guidelines for Early Childhood Education and Care settings. The Menu planning guidelines are based on the Australian Dietary Guidelines. The menu box will be nut free, provide vegetarian options and will be Hallal. Centres will use standard practice to cater for other allergies and/or dietary requirements. The menu box will provide a morning tea, lunch and afternoon tea, and centres will be able to order provisions for breakfast and late snack if required.

Menu boxes containing recipes and ingredients for the week will be delivered to long day care centres once per week. Ingredients will arrive in a delivery box with an insulated liner and ice packs designed to keep ingredients fresh for up to 8 hours and able to withstand most weather conditions. Ordering and use of the menu boxes (i.e. adherence to the intervention) will be monitored using weekly checklists completed by cooks and courier delivery records.
Intervention code [1] 316904 0
Lifestyle
Intervention code [2] 316905 0
Behaviour
Comparator / control treatment
COOK'S TRAINING & MENU PLANNING

The comparison group will complete an online cook's training and use an online menu planning tool developed by dietitians, to review and plan their centre menu and implement the revised menu at the next seasonal menu change.

The online long day care centre cook's training module takes approximately 45-55 minutes to complete on one occasion. The training includes modules covering menu planning, implementing healthy eating guidelines and managing common challenges. Modules provide material on topics such as the importance and benefits of healthy eating, how to utilize the menu planning tool, case study examples and activities and strategies to overcome common challenges.

Cooks will then use automated online menu assessment tool to assess their menu for compliance with the Victorian Menu Planning Guidelines for Long Day Care. Cooks will receive an overview of the serves of each food group that is provided by the menu and recommendations where the menu needs to be reviewed to meet the Menu Planning Guidelines.

The training module, menu assessment and revision will be completed by Cooks within a 6-week period occurring between the end of data collection and commencement of the winter menu change, at which time the revised menu will be implemented (delivery of the menu boxes will also commence at this time-point). This 6-week period allows for sufficient time for cooks to review the menu and implement procedures relating to the revised menu, such as recipes, processes and ordering of foods, prior to the commencement of the new menu. The revised implemented menu will be reviewed after 8-weeks. Completion of the online training and menu assessment will be monitored using website analytics and interviewer administered questionnaires conducted with cooks.
Control group
Active

Outcomes
Primary outcome [1] 322934 0
Vegetable intake at morning tea, lunch and afternoon (at long day care), measured using plate waste method
Timepoint [1] 322934 0
At baseline and 8-week follow-up (post intervention)
Primary outcome [2] 322935 0
Usual dietary intake at long day care over the past month, measured using the Short Food Survey for Early Childhood Education and Care
Timepoint [2] 322935 0
At baseline and 8-week follow-up (post intervention)
Primary outcome [3] 322936 0
Food group provision on long day care centre menu, measured by menu assessment against the Victorian Menu Planning Guidelines using menu assessment tool
Timepoint [3] 322936 0
At baseline and 8-week follow-up (post intervention)
Secondary outcome [1] 380293 0
Cost analysis of menu box delivery versus cook's training and menu planning. Cost data will be collected from centre records and menu box delivery records, including staff time, wages, food budget, food ingredient cost, centre attendance, menu box cost (incl. delivery).
Timepoint [1] 380293 0
At commence and end of the study. Some cost data (i.e. menu box cost, staff time), will also be collected weekly, during the 8-week period intervention period
Secondary outcome [2] 380294 0
Process evaluation - intervention delivery and fidelity.

For Menu Box Delivery group - number of menu boxes ordered, delivered and used, cancellation of menu box orders, measured using electronic records (i.e. emails) of orders and cancellations, and weekly checklist completed by cooks, developed for study.

For Menu Planning group - completion of online training modules and use of menu assessment tool, measured by website analytics and interviewer-administered cook's questionnaire developed for this study.
Timepoint [2] 380294 0
Menu Box Delivery group - weekly during 8-weeks of intervention period

Menu Planning group - At menu change implementation (approximately 6 weeks after baseline, at completion of training and menu assessment)
Secondary outcome [3] 380308 0
Process evaluation - acceptability and satisfaction
Acceptability and satisfaction of interventions will be measured via interviewer administered questionnaires with Cooks, designed for this study. Questionnaires will use questions with closed response options combined with open responses during interview.
Timepoint [3] 380308 0
Menu Box Delivery - At 8-week follow-up (end menu box delivery intervention)
Menu Planning - At menu change implementation (approximately 6 weeks after baseline, at completion of training and menu assessment)
Secondary outcome [4] 380310 0
Process evaluation - feasibility
Feasibility will be measured via recruitment and retention records, interviewer administered questionnaires with cooks and weekly checklist completed by cooks (menu box delivery only). Both instruments were designed for this study.
Timepoint [4] 380310 0
Baseline, weekly during intervention period (checklist), at 8-week follow-up
Secondary outcome [5] 380398 0
Food group intake at long day care centres, measured using the Short Food Survey for Early Childhood Education and Care and plate waste method
Timepoint [5] 380398 0
At baseline and 8-week follow-up (post intervention)

Eligibility
Key inclusion criteria
Long day care centre inclusion criteria:
- Private long day care centres in Adelaide, South Australia
- Operate for at least 8-hours per weekday (Monday - Friday)
- Serve one main meal and two mid-meal snacks each day to children under their care
- Cater, but not exclusively, to children aged two to five years with a minimum enrollment of twenty children within this age group per day

Child inclusion criteria: Child aged 2-5 years enrolled at participating centre and present on data collection day
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Long day care centre exclusion criteria:
- Government long day care centres
- Centres that do not prepare meals onsite by cooks
- Centres catering exclusively to special needs children

Child exclusion criteria: Children with allergies, intolerances or medical conditions that significantly affect their food intake or prevent them from being able to consume 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. Group allocation will be conducted after eligibility and consent process has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomised control trial with allocation at the centre level. Random allocation of Centres will be done using computer number sequence generation (Excel), stratified by socioeconomic status and size of long day care centre. After random allocation of Centres, eligible children within the Centres will be enrolled into the study (using participant opt-out).
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
Sample size was determined based on a change in vegetable intake of ~0.5 serves (1 serve of vegetables = 75g), with an alpha of 0.05 and power of 0.80. Using an intraclass correlation coefficient of 0.1 (clustering at centre level), the required sample size for this study is 160 children. As the average place allocation per long day care centre in South Australia is approximately 60 children of age 2-5 years, recruitment of 8-10 long day care centers, with a minimum of ten to twenty children recruited per centre will be required to achieve the required sample size.

Participant characteristics (long day care centre), food provision and process evaluation data will be presented descriptively. Group differences at follow-up for primary outcomes will be assessed using linear mixed modelling, adjusting for clustering within Centres.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2020
Actual
28/07/2020
Date of last participant enrolment
Anticipated
Actual
4/09/2020
Date of last data collection
Anticipated
Actual
16/12/2020
Sample size
Target
160
Accrual to date
Final
224
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 304955 0
Commercial sector/Industry
Name [1] 304955 0
Horticulture Innovation
Country [1] 304955 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] 305382 0
Government body
Name [1] 305382 0
CSIRO
Address [1] 305382 0
CSIRO - Health & Biosecurity Flagship
SAHMRI Adelaide
PO Box 10041
Adelaide SA 5000
Country [1] 305382 0
Australia
Other collaborator category [1] 281207 0
Commercial sector/Industry
Name [1] 281207 0
Tony and Marks Direct
Address [1] 281207 0
66 Gorge Road
Newton SA 5074
Country [1] 281207 0
Australia
Other collaborator category [2] 281208 0
Charities/Societies/Foundations
Name [2] 281208 0
Nutrition Australia (Victoria Division)
Address [2] 281208 0
118 Cardigan Street
Carlton, Victoria 3053
Country [2] 281208 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305363 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 305363 0
Ethics committee country [1] 305363 0
Australia
Date submitted for ethics approval [1] 305363 0
20/01/2020
Approval date [1] 305363 0
17/02/2020
Ethics approval number [1] 305363 0
8566

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

Contacts
Principal investigator
Name 100126 0
Prof Rebecca Golley
Address 100126 0
Caring Futures Institute
College of Nursing and Health Sciences
GPO Box 2100
Adelaide, SA 5001
Country 100126 0
Australia
Phone 100126 0
+61 8 8201 5596
Fax 100126 0
Email 100126 0
[email protected]
Contact person for public queries
Name 100127 0
Rebecca Golley
Address 100127 0
Caring Futures Institute
College of Nursing and Health Sciences
GPO Box 2100
Adelaide, SA 5001
Country 100127 0
Australia
Phone 100127 0
+61 8 8201 5596
Fax 100127 0
Email 100127 0
[email protected]
Contact person for scientific queries
Name 100128 0
Rebecca Golley
Address 100128 0
Caring Futures Institute
College of Nursing and Health Sciences
GPO Box 2100
Adelaide, SA 5001
Country 100128 0
Australia
Phone 100128 0
+61 8 8201 5596
Fax 100128 0
Email 100128 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
SourceTitleYear of PublicationDOI
Dimensions AIEvaluation of a menu box delivery service for Australian long-day care services to improve food provision and child intake: a cluster randomised controlled trial2023https://doi.org/10.1017/s1368980023002136
N.B. These documents automatically identified may not have been verified by the study sponsor.