Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000358448
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
24/04/2025
Date last updated
24/04/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
AFS: Addressing Food Security for Aboriginal Families
Scientific title
Gandu Connections (Central Coast) and Mid North Coast (MNC):
Addressing Food Security for Aboriginal Families through School and Community Support.
Secondary ID [1] 313992 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food insecurity 336621 0
Condition category
Condition code
Public Health 333123 333123 0 0
Health promotion/education

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

This project includes co-design, implementation of the co-designed strategies and evaluation and reporting. The project provides a framework for co-designing local solutions to food insecurity that links schools, community and relevant local community organisations to address food security for Aboriginal families. It builds on a local pilot project where a working group composed of Aboriginal and non-Aboriginal organisations across the community, health and education sectors co-designed strategies to implement the local primary schools and neighbourhood centre setting to address food insecurity. The framework is evidenced based and informed by the Australian Institute of Family Studies strategies for addressing food insecurity in the Australian context:
1) Partnering to deliver localised solutions
2) Providing emergency food relief
3) Enhancing food and nutrition literacy

An essential part of the project framework is the co-design process, and the development of partnerships between schools and community to support families.
1. Co-design – reflecting the pilot, the co-design process will engage Aboriginal and non-Aboriginal organisations across the community, health and education sectors. Co-design workshops will facilitate the development of suitable strategies that are localised, provide emergency food relief and enhance food and nutrition literacy. The co-design work will determine whether interventions/strategies from the pilot are suitable for local implementation, or whether new strategies are required. The co-design process is ‘in development’ and will be guided by local need. Likely it will include 3-4, 1-hour workshops delivered over a period of 8 weeks to identify local strategies.
2. Interventions: Based on the pilot project the following interventions could potentially be implemented:
a. School level– the provision of a student pantry, lunchbox packs, school support, referral and promotion of neighbourhood centre supports. The local health promotion officer will support the school to implement these strategies, if identified as suitable for the local community through the co-design process.
b. Community level – intake assessment, food relief, referral to relevant supports (financial, electricity bill support, clothing), cooking workshops, and other activities that may be identified through the co-design process. If identified as suitable for the local community through the co-design process, these interventions would be delivered an Aboriginal community liaison officer (ACLO). The interventions will be delivered over the implementation period of four school terms. Families will engage with the ACLO to identify their needs and engage in appropriate aspects of the program to meet their needs, over a relevant time frame.
Intervention code [1] 330519 0
Lifestyle
Intervention code [2] 330518 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340666 0
Extent to which the program shifts food security as indicated by the Hunger Vital SignTM food insecurity screening tool - amended to be used as a using a visual analogue scale (VAS) of 0–100.
Timepoint [1] 340666 0
Baseline and 3-month follow-up completion of intervention
Secondary outcome [1] 444743 0
access to healthy food
Timepoint [1] 444743 0
3-month follow-up post intervention
Secondary outcome [2] 446397 0
Acceptability of program and barriers and enablers
Timepoint [2] 446397 0
Post implementation phase (at 12-month point)
Secondary outcome [3] 444744 0
utilisation of support services
Timepoint [3] 444744 0
baseline and 3-month follow-up post intervention
Secondary outcome [4] 444742 0
food and nutrition literacy is measured as a composite measure
Timepoint [4] 444742 0
baseline and 3-month follow-up post intervention

Eligibility
Key inclusion criteria
Aboriginal families with primary school children experiencing food insecurity.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-Aboriginal families are excluded from the evaluation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a mixed-methods study both quantitative and qualitative analysis will occur.

1. Quantitative:
- Food insecurity will be measured using a visual analogue scale (VAS) of 0–100.
- Summary statistics will be provided for all quantitative variables. For continuous measures, the mean and standard deviation will be used as the summary statistic of choice, but the median and interquartile range will be used for measures that are not approximately normally distributed. Categorical variables such as food and nutrition literacy and knowledge of healthy foods will be summarised using frequencies and percentages.
- The primary outcome measure, food insecurity, will be analysed using a paired t-test to compare the change from pre to post intervention. The effectiveness of the intervention will be summarised as the pre-post difference in the food insecurity VAS along with the corresponding 95% confidence interval and p-value from the paired t-test. Continuous secondary outcomes will also be analysed using paired t-tests and binary outcomes analysed using McNemar’s test.

2. Qualitative"
- Data analysis will also use an Aboriginal lens and be conducted by Aboriginal researchers
- All data will be transcribed verbatim, anonymised, and open coded inductively
- Thematic analysis will then be conducted.
- Member checking will be offered to all participants. This is good qualitative practice and will occur to confirm that meanings and understandings conferred from the data are an accurate representation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318411 0
Government body
Name [1] 318411 0
NSW Ministry of Health - Translational Research Grants Scheme - Round 7
Country [1] 318411 0
Australia
Primary sponsor type
Government body
Name
Central Coast Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320802 0
None
Name [1] 320802 0
Address [1] 320802 0
Country [1] 320802 0
Other collaborator category [1] 283419 0
Government body
Name [1] 283419 0
Mid North Coast Local Health District
Address [1] 283419 0
Country [1] 283419 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317039 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 317039 0
Ethics committee country [1] 317039 0
Australia
Date submitted for ethics approval [1] 317039 0
17/09/2024
Approval date [1] 317039 0
24/10/2024
Ethics approval number [1] 317039 0
2337/24
Ethics committee name [2] 317040 0
Hunter New England Human Research Ethics Committee
Ethics committee address [2] 317040 0
Ethics committee country [2] 317040 0
Australia
Date submitted for ethics approval [2] 317040 0
27/09/2024
Approval date [2] 317040 0
10/10/2024
Ethics approval number [2] 317040 0
2024/ETH01516

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

Contacts
Principal investigator
Name 139798 0
Ms Nicole Kajons
Address 139798 0
Health Promotion Service (HPS) Central Coast Local Health District Level 10, Central Coast Clinical School and Research Institute 77A Holden Street, Gosford NSW 2250
Country 139798 0
Australia
Phone 139798 0
+61 02 43209700
Fax 139798 0
Email 139798 0
[email protected]
Contact person for public queries
Name 139799 0
Nicole Kajons
Address 139799 0
Health Promotion Service (HPS) Central Coast Local Health District Level 10, Central Coast Clinical School and Research Institute 77A Holden Street, Gosford NSW 2250
Country 139799 0
Australia
Phone 139799 0
+61 02 43209700
Fax 139799 0
Email 139799 0
[email protected]
Contact person for scientific queries
Name 139800 0
Nicole Kajons
Address 139800 0
Health Promotion Service (HPS) Central Coast Local Health District Level 10, Central Coast Clinical School and Research Institute 77A Holden Street, Gosford NSW 2250
Country 139800 0
Australia
Phone 139800 0
+61 02 43209700
Fax 139800 0
Email 139800 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Sensitive topic with potentially vulnerable participants



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.