ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625001014448

Ethics application status

Approved

Date submitted

21/08/2025

Date registered

12/09/2025

Date last updated

12/09/2025

Date data sharing statement initially provided

12/09/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Co-designing a treatment approach for cardiovascular disease among Aboriginal and Torres Strait Islander Women

Scientific title

Assessing the feasibility of a co-designed treatment approach for cardiovascular disease among Aboriginal and Torres Strait Islander Women

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Yorga Mooridtj Koort (YMK)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cardiovascular disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Hypertension

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study is also known as Yorga Mooridtj Koort - meaning Women's Strong Heart in Noongar language, which is the language of Noongar people, the Indigenous people of Western Australia. This is a pilot waitlist randomised controlled trial. It assesses the acceptability and feasibility of a culturally tailored lifestyle-based intervention, developed employing a gendered approach, to manage risks of heart disease in Aboriginal and Torres Strait Islander (hereafter Aboriginal) women in the Perth metropolitan area in Western Australia.

The 12-week intervention program will be guided and led by an Aboriginal Health Practitioner (AHP), a registered nurse (RN) and a General Practitioner (GP), specialised in chronic disease management, and at the study site (1 clinic) - an Aboriginal Community Controlled Health Service (ACCHS). The program will involve a combination of lifestyle-based cardiovascular risk reduction interventions which will address: heart-healthy eating and individualised dietary counselling delivered by a trained dietitian, physical activity coaching sessions conducted by an exercise physiologist, and a GP/AHP-led smoking cessation support (for current smokers) and smoking abstinence maintenance (for participants who quit smoking in the past 12 months).

Two-armed randomised waitlist- controlled trial aimed at reducing the risk of coronary heart disease in Aboriginal women. Participants are randomised to either the intervention arm/group or the waitlist arm/group.

Participants randomised to the intervention arm/group will receive a registered nurse (RN), an Aboriginal Health Practitioner (AHP) and a general practitioner (GP) coordinated care package that includes counselling and practical guidance on dietary advice (DA), physical activity (PA), and smoking cessation (SC). Participants will see the trial GP(s) at the beginning of the intervention and, where required (based on bloods taken at baseline), participants will be prescribed medications for blood pressure (BP) and/or lipid management and/or nicotine replacement therapy (NRT) for smoking cessation (for participants interested in quitting). All prescribed medications for blood pressure (BP) and/or lipid management and/or nicotine replacement therapy will be at the physicians discretion. The intervention/program is designed for Aboriginal women. Participants can bring family members who are willing to join them in sessions. However, no data will be collected about family members who may be attending. The intervention/program period will be 12 weeks long: – 4 weeks of intensive (i.e. more frequent) in-person sessions followed by 8 weeks of maintenance phase (i.e. less frequent).

In the intensive phase, participants will attend one session per week (a combination of GP, DA, PA and SC [if applicable], and “check-in” with the AHP; (1x4=4 i.e., 4 sessions in 4 weeks). In the first week, participants will see the GP and AHP; sessions will be up to 80 minutes (1h 20m) long. The session duration in the following weeks maybe up to 120 minutes (2h). SC sessions will apply to participants who identify as current smokers or recent quitters (i.e. quit in the last 12 months) and are interested in quitting. All sessions will be conducted in person where individual participants will receive the intervention from session-specific healthcare providers, with PA sessions provided taking a mixed approach (i.e. group demonstration and individual practice). Exercise programs would be tailored to participant group needs with a combination of appropriate cardio such as running or jogging on a treadmill and steady-state cardio on an exercise bike and resistance training such as squats and lunges, bicep curls, band rows and lateral walks. State of physical ability will be measured via: a) hand grip test (for muscular strength and general physical health), b)6-minute step test (for exercise tolerance, functional capacity and heart rate recovery), c) 30-second chair stand test (for muscular endurance, mobility and balance), and d) 3-metre Up and Go test (for mobility and balance). All test items were selected in consultation with the trial Exercise Physiologist with prior experience of working with Aboriginal communities in similar clinical trials.

During the maintenance phase, participants will attend one session every fortnight (i.e. four sessions over eight weeks), which is the key distinction from the intensive phase. While the content of sessions remains consistent across both phases, the maintenance phase introduces additional group-based nutrition activities—such as cooking demonstrations and interactive, participatory sessions—alongside individual diet and nutrition counselling (DA) sessions. Each session will include 60 minutes of physical activity (PA), followed by 40 minutes of group and/or individual DA sessions, and 20 minutes of a ‘check-in’ with a Registered Nurse (RN) or Aboriginal Health Practitioner (AHP). For participants who smoke and are attempting to quit, expired carbon monoxide (CO) levels will be monitored using a CO monitor. Recent quitters may also seek support from the RN/AHP if needed. In weeks when participants do not attend in-person sessions, the AHP will conduct check-ins via phone. To support flexibility and encourage engagement, PA and group DA sessions will be offered multiple times each week or fortnight, and interested participants are welcome to attend additional sessions.
Participants will undergo assessments at baseline, 12 weeks (endline), and 25 weeks (follow-up). Session attendance will be recorded in the REDCap trial database. While adherence to individual sessions will not be actively monitored, the attendance data will provide insight into participant engagement.

To encourage incidental physical activity, each participant will be given a Fitbit (or similar device) to be able to self-monitor their daily step count. Data about participants’ step counts will be centrally recorded through Fitbit accounts to which all Fitbit devices will be connected. To reduce biases, each week, the RN/AHP will ask participants about their step count of the previous day (over-the-phone on gap weeks and in-person on intervention weeks) and record it in the trial database.

In compliance with ethical conduct of research, all participants, regardless of group allocation, will have a GP management plan (GPMP), team care arrangement (TCA) and social and emotional wellbeing (SEWB) support plan, as required (and will be noted during analysis/reporting). Participants requiring SEWB support will receive care during follow up GP appointments for medication review as well as according to Derbarl Yerrigan Health Service’s (DYHS) usual SEWB care pathways where necessary.

Intervention code [1]

Prevention

Comparator / control treatment

This study will have a waitlist control group. Participants in the waitlist arm/group will not receive the intervention/program for the first 12 weeks (while intervention participants undergo intervention/program). They will complete a baseline andn endline assessment (identical to intervention participants) and then be offered the opportunity to receive the intervention/program. If they accept, they will receive the intervention/program. A final follow-up assessment will be completed 25-weeks post-randomisation (i.e. 12 weeks in waitlist, plus 12 weeks of intervention).

Control group

Active

Outcomes

Primary outcome [1]

% of the participants attended 50% of the sessions.

Timepoint [1]

Immediately after intervention (13-14 weeks post-randomisation).

Primary outcome [2]

Acceptability of the intervention will be measured.

Timepoint [2]

Within 12 weeks of the last assessment (25-26 weeks post randomisation).

Secondary outcome [1]

% of participants with blood pressure target of <130mmHg systolic blood pressure (SBP) and <85mmHg diastolic (DBP) OR see a reduction in the baseline level (if elevated) OR maintain baseline SBP and DBP. This outcome will be measured as a composite measure.

Timepoint [1]