Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000485538p
Ethics application status
Not yet submitted
Date submitted
14/03/2024
Date registered
19/04/2024
Date last updated
19/04/2024
Date data sharing statement initially provided
19/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and feasibility of enabling healthy, affordable, environmentally sustainable childcare food provision at scale.
Scientific title
Assessing the adoption, acceptability, feasibility and impact of co-designed strategies to enhance awareness and generate practice change regarding healthy, environmentally sustainable and affordable food provision in childcare settings.
Secondary ID [1] 311744 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Promotion of healthy and environmentally sustainable dietary choices 333226 0
Condition category
Condition code
Diet and Nutrition 329915 329915 0 0
Other diet and nutrition disorders
Public Health 329916 329916 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project will utilise a randomised control trial (RCT) design to explore the impact of two food waste reduction strategies, individually and in combination, namely, a purpose-designed food waste audit and whole-of-centre resources, including classroom activities. Both strategies were co-designed using the IDEAS Framework, between the research team (research nutritionists and dietitians), childcare centre staff (cooks, educators and directors) and the Healthy Eating Advisory Service, a Victorian Government funded program delivered by Nutrition Australia (publication under review). This process involved participation in semi-structured interviews to understand the barriers and enablers to the provision of healthy, sustainable food, followed by two video-conference focus groups with interviewees to explore support options to address these needs.

Childcare services will be recruited from the national Australian Children’s Education & Care Quality Authority (ACECQA) registry, Recruitment strategy and sample size estimations are based on studies undertaken by the researchers and others. Recruited childcare centres (n=~30) will be stratified by locality (regional/metropolitan), and socioeconomic position using the Australian Socio-Economic Indexes for Area (SEIFA), then randomized into 3 groups.

Group 1 will be exposed to a self-report 1-day food waste audit, Group 2 will be exposed to whole-of-centre resources, and Group 3 will be exposed to both the food waste audit and resources. Exposure to each intervention condition will be an 8-week period to allow sufficient time to detect practice change. After the 8-week period, a self-report 1-day food waste audit will be conducted across all Groups as post-intervention data collection.

For the purpose-designed food waste resource:
This self-report audit tool has been utilised by the research team previously (Elford A, Spence AC, Wakem A, Rozman M, Campbell KJ, Love P. Environmental sustainability and food provision in the early childhood and education setting. Public Health Nutrition. 2023;26(11):2200-2210. doi:10.1017/S1368980023001908), and provides a non-invasive approach. A paper copy of the audit protocol, audit record and a calibrated commercial scale will be couriered to each childcare service ahead of the audit. A member of the research team will then contact the service by telephone to confirm receipt and understanding of the protocol. Service staff responsible for food provision are required to weigh all foods/beverages consumed during 1-day. The audit diary is used to record weights and photographs (using mobile phones or other eg: tablets) are taken of all foods/beverages being weighed. Weights are recorded/photographed at food preparation stage for the entire childcare service. One 2- to 5-year-old room is selected at random to collect weights and photographs of a) all food prepared; b) food prepared but not served (serving waste); c) food plated and served but not eaten (plate waste). The completed audit diary and all photographs are to be emailed to the research team, where verification checks of recorded weights on protocol templates will be made against photographs of weighed items. A member of the research team will be available by phone throughout the self-report audit as needed. The research team member will also arrange for the calibrated scale to be couriered back to the University.

For the whole-of-centre resources, including classroom activities:
This resource features a 'toolkit' with tips and links to resources for each staff member (manager, educator, cook). The links to resources are Australia-specific examples, to enable implementation of the Sustainable Healthy Diets guiding principles. It will be recommended that the childcare service designate 1-week within the intervention period as "Food Waste Awareness Week" and use the 'toolkit' during this time to identify and implement relevant sustainable healthy food provision practices, and to deliver a 10-15min classroom activity. The classroom activity will involve children scraping their left-over food from the main meal into buckets and measuring this food waste using a ruler. During usual group 'circle' time, the educator will talk with the children about the food waste, engaging with them through drawings. The research team will be available to the childcare service for any questions regarding the use of the toolkit in the setting up the "Food Waste Awareness Week". Post-intervention surveys will be used to monitor uptake, acceptability, appropriateness and feasibility of the resources. Drawings made by children (regarding their understanding of "food waste") during the classroom activity will also be collected.
Intervention code [1] 328200 0
Prevention
Intervention code [2] 328201 0
Behaviour
Comparator / control treatment
After the 8-week exposure period, all measures will be repeated, with a 1-day food waste audit across all groups. The food waste audit cannot be conducted at baseline given it also acts as an intervention itself, so data analysis will include pre-post comparison as well as comparison between trial arms.
Control group
Active

Outcomes
Primary outcome [1] 337685 0
changes in awareness regarding environmentally sustainable food practices, including food waste
Timepoint [1] 337685 0
T1 - pre-intervention
T2 - post-intervention (primary timepoint) at 8 weeks
Primary outcome [2] 337933 0
changes in practices regarding environmentally sustainable food practices, including food waste
Timepoint [2] 337933 0
T1 - pre-intervention
T2 - post-intervention (primary timepoint) at 8 weeks
Secondary outcome [1] 432826 0
organisational readiness for strategy implementation
Timepoint [1] 432826 0
T1 - pre-intervention
Secondary outcome [2] 432828 0
organisational feasibility of strategy implementation
Timepoint [2] 432828 0
T2 - post-intervention at 8 weeks
Secondary outcome [3] 433788 0
changes in menu compliance (healthfulness)
Timepoint [3] 433788 0
T1 - pre-intervention
T2 - post-intervention at 8 weeks
Secondary outcome [4] 433789 0
changes in food costs (affordability)
Timepoint [4] 433789 0
T1 - pre-intervention
T2 - post-intervention at 8 weeks
Secondary outcome [5] 433790 0
changes in food waste
Timepoint [5] 433790 0
T2 - post-intervention at 8 weeks - across intervention groups

Eligibility
Key inclusion criteria
Childcare services in Australia, approved as Long Day Care (LDC) / Centre-based care services, catering to children aged 0–6 years, operating for at least 8h per day, 48 weeks per annum, with on-site food preparation and provision.

Childcare services providing organisational consent for food waste audit data collection.
Childcare services staff providing individual consent for online survey data collection.
Parental consent provided to the childcare service for the inclusion of a child's (de-identified) drawing.

Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Childcare services outside of Australia
* Unapproved Long Day Care (LDC) / Centre-based care services
* Long Day Care (LDC) / Centre-based care services without on-site food preparation and provision
* Childcare services within Australia defined as Family Day Care, In-Home Care, Outside School Hours Care or Occasional Care services
* Childcare services and staff not providing relevant consent for participation

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation by locality (regional / metropolitan) and socioeconomic position (SEIFA)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316076 0
University
Name [1] 316076 0
Deakin University Faculty of Health Research Capacity Building Grant Scheme (HAtCH)
Country [1] 316076 0
Australia
Primary sponsor type
Individual
Name
Dr Penelope Love
Address
Country
Australia
Secondary sponsor category [1] 318242 0
Individual
Name [1] 318242 0
Prof Kylie Hesketh
Address [1] 318242 0
Country [1] 318242 0
Australia
Other collaborator category [1] 282979 0
Individual
Name [1] 282979 0
Dr Alison Spence
Address [1] 282979 0
Country [1] 282979 0
Australia
Other collaborator category [2] 282980 0
Other
Name [2] 282980 0
Ms Margaret Rozman, Nutrition Australia Vic
Address [2] 282980 0
Country [2] 282980 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314894 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 314894 0
Ethics committee country [1] 314894 0
Australia
Date submitted for ethics approval [1] 314894 0
22/04/2024
Approval date [1] 314894 0
Ethics approval number [1] 314894 0

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

Contacts
Principal investigator
Name 133078 0
Dr Penelope Love
Address 133078 0
Deakin University, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 133078 0
Australia
Phone 133078 0
+61352278484
Fax 133078 0
Email 133078 0
[email protected]
Contact person for public queries
Name 133079 0
Penelope Love
Address 133079 0
Deakin University, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 133079 0
Australia
Phone 133079 0
+61352278484
Fax 133079 0
Email 133079 0
[email protected]
Contact person for scientific queries
Name 133080 0
Penelope Love
Address 133080 0
Deakin University, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 133080 0
Australia
Phone 133080 0
+61352278484
Fax 133080 0
Email 133080 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
* de-identified centre staff awareness, knowledge, practices, perceptions
* de-identified centre-level organisational readiness for strategy adoption
* de-identified centre-level food provision, food cost, food waste
When will data be available (start and end dates)?
Immediately following publication and available for 5 years after publication.
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
case-by-case basis at the discretion of Primary Sponsor
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


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.