Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001418864
Ethics application status
Approved
Date submitted
3/08/2021
Date registered
21/10/2021
Date last updated
21/10/2021
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Deadly Koolinga Chef Program: A community-based cooking program for Aboriginal children and adolescents, pregnant women, breastfeeding mothers, and their families
Scientific title
Deadly Koolinga Chef Program: Kwob mereny, moorditj kaadadjan (good food, wonderful learning)- Efficacy of a community-based cooking program on food literacy and nutritional outcomes in Aboriginal children and adolescents, pregnant women, breastfeeding mothers, and their families
Secondary ID [1] 304930 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
DKCP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Under-nutrition 323076 0
Over- nutrition 323077 0
Condition category
Condition code
Diet and Nutrition 320654 320654 0 0
Other diet and nutrition disorders
Diet and Nutrition 320876 320876 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are four components to the DKCP:

Component One
The cooking and nutrition class/workshop component will be conducted from September / October 2021 to September 2023 for the first two years of the research initiative, at each of the participating sites: The Murray Districts Aboriginal Association (MDAA) Centre (Pinjarra, WA), and the Winjan Aboriginal Association (Winjan) Centre (Mandurah, WA) in partnership with the Nidgalla Waangan Mia (NWM) Aboriginal Health Service (AHS) (Mandurah, WA), and at the Kulunga Moort Mia (KMM) Aboriginal family lounge at the Perth Children’s Hospital (PCH) WA, in partnership with PCH’s Nutrition and Dietetics Department.

The children (6-12 years) will attend weekly cooking and nutrition classes during the West Australian school terms (28 per year), at all partner sites, and the adolescents (13-17 years), pregnant women and breastfeeding mothers will attend 10 workshops per year (one every 5 - 6 weeks) at the MDAA and Winjan sites. The cooking classes will be 2.5 - 3 hours each, and the half day workshops will be 4 – 5 hours each. Each participant will take home a family meal for 4-6 people after each class/workshop to contribute to the family food work.
Nutrition and food skills activity workbooks with age-appropriate activities will be provided to each participant at each cooking class/workshop participant at each session. The activity workbooks will focus on developing nutrition knowledge, healthy eating behaviours and kitchen and food safety skills. Thirty minutes will be allocated to completing the workbooks during the introduction to each class/workshop and workbook completion records for each participant will be recorded by the community Elder DKCP Research Associates (RAs). Any further completion of the workbooks outside the cooking sessions will be done at the participant’s discretion. The DKCP website will be developed to support the delivery of the DKCP to the participating sites (term plans for the cooking classes/workshops, class/workshop lesson plans, recipes, project updates, children’s nutrition workbooks, nutrition and dietetics information and links to other relevant websites).

At each cooking class / workshop there will be 10-15 cooking stations and to ensure equity in participation a rolling family roster will be maintained allowing for all eligible children / adolescents in any one family to participate equally, and to allow for as many families as possible to be accommodated. Class / workshop attendance registers will be maintained, and this data will determine the time/length of exposure to the learning opportunities offered by attending and participating in the DKCP, compared to nutrition knowledge development data from pre- and post-testing.

Component Two
The research component will run concurrently alongside the cooking and nutrition component from September / October 2021 to September 2023. A Community Based Participatory Action Research (CBPAR) approach (Burns et al., 2011) underpinned by the Making Two World Work (MTWW) Aboriginal Health Promotion Framework (MAC & WHGNE, 2008), will be employed. CBPAR is a collaborative approach to research that involves all stakeholders throughout the research process, from establishing the research question, to developing data collection tools, to analysis, evaluation and dissemination of findings (Burns, et al., 2011). CBPAR recognises that community knowledge is irreplaceable and provides key insights that ‘ground-truths’ observational data, and that there is value and legitimacy in the knowledge of community individuals and families. The MTWW Aboriginal health promotion framework is underpinned by the Aboriginal ethical principles of partnerships, participation and empowerment, social justice and equity, and the determinants of Aboriginal social and emotional wellbeing, and proposes empowerment as its foundation (MAC & WHGNE, 2008). The DKCP will be evaluated using Realist Evaluation (RE) (Pawson & Tilley, 1997). RE guided by the Indigenous Evaluation Strategy (2000) will measure the impacts of the DKCP on the community members’ lives. Therefore, RE will: (a) evaluate the positive and negative, primary and secondary long-term impacts that result from the DKCP; (b) assess the direct and indirect contribution of the DKCP to such impacts, regardless of intention; and (c) explain how the DKCP contributes to policy and practice from the lessons learned

The Aboriginal Advisory Group (AG), the Chief Investigator (CI) research team, Aboriginal Health Workers (AHWs), Aboriginal Health Professionals (AHPs) and community Elders from the partner sites will develop the DKCP Research and Data Management Plan and regularly review all the processes of the research and the cooking and nutrition component against the MTWW framework to ensure adherence to culturally appropriate protocols. Initial contact to provide the communities with information on the DKCP will be through community gatherings. These gatherings will be held at the sites noted above. The AHWs and RAs will be well versed in the DKCP and the research components and will ‘yarn’ informally with the community members while handing out the DKCP information sheet. The RAs will also guide the participants through the consent form, highlighting the participants’ rights to withdrawal from the cooking and nutrition classes / workshops and or the research and evaluation component at any time without penalty. The RAs will also discuss the processes of confidentiality, the methods of data collection and the collaborative and consultative approaches that will be used in analysing the data and the dissemination of the findings. The AHWs, AHPs and RAs supported by the CIs will attend the cooking classes and manage the attendance rosters, and oversee the completion of the workbooks, and participate in the collection of the qualitative and quantitative data.
Data collection will be in the form of:
Qualitative data: Individual and group yarning (Bessarab & Ng'andu, 2010) will be undertaken to obtain a holistic understanding of the communities’ experiences of participating in the DKCP
Narrative art project: The use of art narrative enables cultural expression and symbolic representation of the emotional and physical experiences related to the child /adolescent’s individual participation in the DKCP through the use of traditional art.
Statistical data:
• Demographic Data: Address, age, sex, position in the family, family relationships, year level at school;
• Attendance registers of participants and helpers at the classes and workshops;
• The child nutrition knowledge survey; 14-item questionnaire (Wilson et al., 2008);
• Australian Child and Adolescent Eating Survey Food Frequency Questionnaire (ACAES-FFQ) (Watson et al., 2009);
• The Structure and Control in Parent Feeding (SCPF) questionnaire (Savage et al., 2017);
• 24-hour recall food intake diary;
• The Growth and Empowerment Measure (GEM) (Haswell et al., 2010); and
• Nutrition Activity Workbook completion records for each participant will be recorded.

Component Three
The training and up-skilling component will also commence in September / October 2021 and will extend to December 2023. Accredited Certification training facilitated by registered training organisations either by on-line or face-to face enrolment will be offered in the areas of nutrition and dietetics, community development / project management, and research processes. Depending on the topic area selected the courses will take between 12 – 18 months to complete. The courses will be offered to workforce members from the participating sites initially, and then to other Aboriginal Health Services and community organisations who are interested in implementing the DKCP into their services after the research time frame.
The workforce members and identified community members facilitating the cooking classes/workshops at the participating sites will undertake on-the-job skills training during the delivery of the cooking classes / workshops. For those facilitators enrolled in a nutrition and dietetics course, the skills training will be further supported by the learned theoretical knowledge. The cooking classes will be delivered by a CI research member with cooking class facilitation qualifications overseen by the CI dietitians. To support the roll out of the initiative and to train as many members as possible a train-the-trainer model will be employed at the sites for the duration of the cooking class/ workshop component.

Component Four
The dissemination of the DKCP will commence in July / August 2023. Outcomes and findings will be via co-authorship of articles and reports, co-presentation at workshops and conferences, and recommendations will be available publicly for policy makers and service providers to learn from, apply, and build on. All findings will be disseminated to the WA Aboriginal Health Services through individual distribution and through the CEO Forum of the Community Controlled Aboriginal Health Services, the WA Health Department Child and Adolescent Health Department, the West Australian Country Health Service and the WA Primary Health Alliance. Study findings will also be available through the DKCP website. The art produced by the children and adolescents will be a process in the dissemination of the findings to the wider community by means of a public exhibition.
Monitoring - Adherence / Fidelity to the Intervention
• The Aboriginal AG, CI research team, AHWs, AHPs and RAs will collaboratively develop the:
• DKCP Delivery Plan and will review it against the MTWW Framework at 6 monthly intervals. This will also include:
o Registers of attendance;
o Workbook completions;
o Kitchen safety monitoring; and
o Food safety monitoring;
o Current Working with Children Checks
• DKCP Research and Data Management Plan and will review it at 6 monthly intervals against the AIATSIS (2020) Code of Ethics for Aboriginal and Torres Strait Islander Research; NHMRC (2019) Management of Data and Information in Research: A guide supporting the Australian Code for the Responsible Conduct of Research; and the Australian Research Data Commons Research Data Rights Management Guide.
• The DKCP Budget and Expenditure will be reviewed regularly by the CI research team timely adjustment made as necessary; and
• An upskilling and training register will be maintained and regularly reviewed by the CI research team for status on current enrolments, intermissions, completions and withdrawals.
Intervention code [1] 321333 0
Lifestyle
Intervention code [2] 321486 0
Treatment: Other
Intervention code [3] 321487 0
Behaviour
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328485 0
Children food literacy assessed using the child nutrition knowledge survey; 14-item questionnaire.

The questionnaire is not study specific, however it has been validated and permission has been granted to use the tool:
Wilson, A., Magarey, A., & Mastersson, N. (2008). Reliability and relative validity of a child nutrition questionnaire to simultaneously assess dietary patterns associated with positive energy balance and food behaviours, attitudes, knowledge and environments associated with healthy eating. International Journal of Behavioral Nutrition and Physical Activity, 5. https://ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-5-5
Timepoint [1] 328485 0
Baseline, 1 year, 2 years (primary endpoint) post-intervention commencement
Primary outcome [2] 328677 0
Adolescents, pregnant women and breastfeeding mothers' food literacy assessed using the and the Australian eating survey (Australian child and adolescent eating survey and Australian adult eating survey).
Timepoint [2] 328677 0
Baseline, 1 year, and 2 years (primary endpoint) post-intervention commencement
Primary outcome [3] 328678 0
Individual and community social and emotional well-being evaluated using the growth and empowerment measure (GEM)
Timepoint [3] 328678 0
Baseline, 1 year, and 2 years (primary endpoint) post-intervention commencement
Secondary outcome [1] 399152 0
Nutritional intake assessed using a 24-hour recall food intake diary designed specifically for this study
Timepoint [1] 399152 0
Baseline, 1 year, and 2 years post-intervention commencement
Secondary outcome [2] 399927 0
Parental control of children's and adolescent's eating assessed by the structure and control in parent feeding (SCPF).
Timepoint [2] 399927 0
Baseline, 1 year, and 2 years post-intervention commencement

Eligibility
Key inclusion criteria
Aboriginal children aged 6-12 years, adolescents aged 13-17 years, pregnant women, and breastfeeding mothers residing in Pinjarra or Mandurah or who attend the Perth Children’s Hospital for health care; and
Aboriginal parents / carers of the children or adolescents who are participating in DKCP cooking and nutrition classes / workshops and or the DKCP research component at the sites in Pinjarra, Mandurah, and the Perth Children’s Hospital.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
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
Children’s cooking and nutrition classes will be held at the three sites in Pinjarra, Mandurah and in Perth. The adolescent, pregnant women and breastfeeding mother workshops will only be held in Pinjarra and Mandurah. Because the DKCP is a pilot project, a framework which we can use to draw the participant sample size from is not available, therefore for the purpose of identifying the potential participants at each site the ABS (2016) Census data and the AIHW (2019) Australian mothers and babies data will be used.
There is a potential for 1153 Aboriginal households in the research sites to benefit from the DKCP during the research timeframe. An average of 3.07 people resides in each household, which equates to a total of 3536 individuals. Approximately 22% of those are children aged 5-14 years, which equates to 777 potential child participants, of which 382 will be attend the Perth site. Of the remaining 2759 individuals, 1283 from Perth (15-65+ years) will be subtracted to leave the remaining total of 1476 individuals in Pinjarra and Mandurah. Of the remaining approximately 20% are adolescents and young adults (15-24 years), and 49% of those are female resulting in 131 male, and 125 female adolescents and young adults. To arrive at an approximate number of adolescent male and female participants (13-17 years) the numbers have been halved to a total of 128. According to the AIHW (2019), teenage mothers are classified as those under the age of 20, and the rate of Indigenous teenage births in 2019 was 1.14%. Of the 125 potential female teenage participants, 1-2 of them may be pregnant or breastfeeding. To capture the remaining potential pregnant and or breastfeeding participants the adult age group of 25-44 years is being used. Of the 1027 remaining individual 25% are within this age range and 49% are female, which equates to 125 individuals. It is expected that parent / carers of a children and adolescents attending the cooking classes / workshops will participate as helpers. Parent / carer helpers will also be invited to participate in the research component, and it is anticipated that this will equate to between 20-30 participants. The resultant potential participant numbers are:
• Perth: 382 (children only); 15 parent / carers
• Mandurah and Pinjarra: 395 children, 128 adolescents, 125 pregnant women and breastfeeding mothers, 15 parent / carers
• PARTICIPANT TOTAL: 1060

There are a total of 1718 Aboriginal and/or Torres Strait Islander people living in Mandurah; 840 males and 875 females with a median age of 20, and the average number of people per household is 3.3 equating to approximately 520 households. The Aboriginal and/or Torres Strait Islander population of Pinjarra and surrounds (ABS, 2016a), is 199; 93 males and 106 females with a median age of 17 years, and the average number of people per household is 3.6, which equates to 55 households. Therefore, there is the potential for 574 Aboriginal and/or Torres Strait Islander households in Mandurah and Pinjarra to receive both short- and long-term benefits from the DKCP during the research timeframe.

To identify the number of Aboriginal and/or Torres Strait Islander peoples living in the Perth region alone was complicated by the Australian Bureau of Statistics zoning of the region. The available statistics were of the Greater Perth region, which covers 6416.2 sq Kms and extends from Joondalup in the north to the southern borders of the Mandurah, incorporating all the suburbs in between. The Greater Perth region statistics indicate a total Aboriginal and/or Torres Strait Islander population of 29,519. It is anticipated that only those families living within a reasonably close proximity to Kulunga Moort Mia (PCH) will attend that site on a regular ongoing basis. For the purpose of identifying the potential participants for the DKCP at Kulunga Moort Mia (PCH), the Perth electoral locality (ABS 2016) covering 75.4sq Kms was used, and it identified a total population of 1735 people. Of this group, 871 are males and 867 females, of which 382 are aged between 5 – 14 years, with an average number of people per household being 3, which equates to a total of 578 households.

Qualitative data analysis: The data from the yarning groups and individual yarns will be recorded and professionally described. Other relevant documents such as meeting notes, facilitator notes, and discussions will be transferred to word documents. These documents will be amalgamated using NVivo 12®. Data segments will be amalgamated by theme and coded in an iterative process with themes and sub-themes reviewed by the research team in collaboration with the AHWs, APHs and RAs throughout the process. This collaboration also ensures that concepts and themes derived from the data will be culturally interpreted rather than just described (Louis, 2007). Lassiter (2001, p. 139) refers to these processes as the ability to work ‘alongside’ community members as processes develop and “using the developing text as the centrepiece of evolving ongoing conversation”, “not just sitting down to verify quotes”. Further, these processes reaffirm the research to be community controlled (Couzos et al., 2005). The data will be provided to the AG and to the communities for review and discussion, and any correction in interpretation.

Statistical data analysis: Descriptive data concerning attendances and completions of workbook activities, along with demographic data, will be reported as frequencies and percentages and where relevant, as means and standard deviations or medians and interquartile range (IQR), according to normality. A common method of combining nutritional items into food groups is principal component analysis/factor scores, and these are useful when the interest is in combining food groups. However, in the DKCP we are interested in knowing the food preferences of individuals, and these data reduction methods do not allow the study of individual preferences. Moreover, the above methods combine item scores in a linear fashion which assume perfect substitutability among items. This once again is not true in terms of food items and groups as they have their own nutritional importance. It is for this reason we will develop a new diet index that would allow us to combine these multidimensional choices using preference based utilities, which are concepts usually used in Economics. In order to establish predictors of health outcomes we will use multi-level models to properly tease out the variance due to repeated measurements. The Ngangk Yira health economist and statistician will also have oversight of this process to provide the framework for measuring and evaluating cost and value of DKCP health promotion intervention (WAHTN, 2018)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/10/2021
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
1060
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 34848 0
6210 - Mandurah
Recruitment postcode(s) [2] 34849 0
6208 - Pinjarra
Recruitment postcode(s) [3] 34850 0
6909 - Nedlands

Funding & Sponsors
Funding source category [1] 309309 0
Government body
Name [1] 309309 0
Australian Health Department
Country [1] 309309 0
Australia
Funding source category [2] 309323 0
Charities/Societies/Foundations
Name [2] 309323 0
Ian Potter Foundation
Country [2] 309323 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WESTERN AUSTRALIA 6150
Country
Australia
Secondary sponsor category [1] 310292 0
Other
Name [1] 310292 0
Nidjalla Waangan Mia Aboriginal Health Service
Address [1] 310292 0
112 Lakes Rd, Mandurah WESTERN AUSTRALIA 6210
Country [1] 310292 0
Australia
Secondary sponsor category [2] 310293 0
Hospital
Name [2] 310293 0
Perth Children's Hospital
Address [2] 310293 0
15 Hospital Ave, Nedlands WESTERN AUSTRALIA 6009
Country [2] 310293 0
Australia
Other collaborator category [1] 281930 0
Other Collaborative groups
Name [1] 281930 0
Murray Districts Aboriginal Association
Address [1] 281930 0
60 Hampton Road, Pinjarra WESTERN AUSTRALIA 6208
Country [1] 281930 0
Australia
Other collaborator category [2] 281931 0
Other Collaborative groups
Name [2] 281931 0
Winjan Aboriginal Corporation
Address [2] 281931 0
19 Alderley Place, Mandurah, WESTERN AUSTRALIA 6210
Country [2] 281931 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309138 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 309138 0
Ethics committee country [1] 309138 0
Australia
Date submitted for ethics approval [1] 309138 0
19/05/2021
Approval date [1] 309138 0
15/06/2021
Ethics approval number [1] 309138 0
1080

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

Contacts
Principal investigator
Name 113118 0
A/Prof Caroline Nilson
Address 113118 0
Murdoch University, 1 Education Drive, Mandurah WESTERN AUSTRALIA 6210
Country 113118 0
Australia
Phone 113118 0
+61 439988139
Fax 113118 0
Email 113118 0
[email protected]
Contact person for public queries
Name 113119 0
Caroline Nilson
Address 113119 0
Murdoch University, 1 Education Drive, Mandurah WESTERN AUSTRALIA 6210
Country 113119 0
Australia
Phone 113119 0
+61 439988139
Fax 113119 0
Email 113119 0
[email protected]
Contact person for scientific queries
Name 113120 0
Caroline Nilson
Address 113120 0
Murdoch University, 1 Education Drive, Mandurah WESTERN AUSTRALIA 6210
Country 113120 0
Australia
Phone 113120 0
+61 439988139
Fax 113120 0
Email 113120 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
De-identified individual participant data will not be available for this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12742Study protocol  [email protected]
12743Informed consent form    Attachment 382515-(Uploaded-02-08-2021-19-39-32)-Study-related document.pdf
12744Informed consent form    Attachment 382515-(Uploaded-02-08-2021-19-39-56)-Study-related document.pdf
12750Ethical approval    Attachment 382515-(Uploaded-03-08-2021-08-38-09)-Study-related document.pdf



Results publications and other study-related documents

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Documents added automatically
No additional documents have been identified.