Preventing Indigenous Cardiovascular Disease and Diabetes Through Exercise (PrIDE) Study Protocol: A Co-Designed Wearable-Based Exercise Intervention with Indigenous Peoples in Australia

Abstract

Chronic diseases disproportionately impact Indigenous peoples in Australia, with type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) representing leading causes of morbidity and mortality. Despite evidence supporting community-based exercise interventions for T2DM management, no culturally adapted programs utilizing wearable technology have been co-designed specifically with Indigenous Australian communities. This study protocol aims to determine if wearable-based exercise interventions can effectively prevent CVD development and manage T2DM progression in Indigenous Australians through culturally safe, community-led approaches. The PrIDE study protocol describes a mixed-methods translational research design incorporating Indigenous and Western methodologies across three phases: (1) co-designing culturally adapted exercise programs and assessment tools, (2) implementing interventions with wearable monitoring, and (3) conducting evaluation and scale-up assessment. Sixty-four Indigenous Australian adults with T2DM will be recruited across remote, rural/regional sites to self-select into either individual or group exercise programs using the Withings ScanWatch 2. Primary outcomes include cardiovascular risk factors, physical fitness, and health self-efficacy measured using culturally adapted tools. Indigenous governance structures will ensure cultural safety and community ownership throughout. The PrIDE protocol presents a novel approach to improving health equity while advancing understanding of wearable technology integration in Indigenous healthcare, informing future larger-scale trials and policy development.

1. Introduction

Chronic diseases are the leading cause of avoidable death among Indigenous peoples in Australia aged 55 and over [1]. Indigenous peoples in Australia experience significantly higher rates of chronic disease compared to non-Indigenous Australians [2], and those living in rural and remote areas are disproportionately affected by conditions such as cardiovascular disease (CVD), type 2 diabetes mellitus (T2DM), cancer, and mental illness [3]. While coronary heart disease is the leading cause of death across all geographic regions, its prevalence in remote areas is up to 1.7 times higher than in major cities [4].

Indigenous people in Australia experience disproportionate burden from T2DM and CVD compared to other Australians [2]. In 2018, the age-standardized rate of burden due to T2DM was 4.1 times higher, and CVD was 2.4 times higher for Indigenous Australians [2]. More than one-third of Indigenous adults aged 55 and over live with T2DM, and it accounts for over 7% of all Indigenous deaths [5]. The interconnected nature of diabetes and cardiovascular complications, including atrial fibrillation (AF), creates compounding health risks, with T2DM acting as both an independent risk factor for CVD and AF [6,7] while AF itself occurs more commonly and at younger ages in Indigenous populations. This burden extends beyond those with established disease to include the substantial population at risk of developing these conditions.

Although chronic diseases such as CVD and T2DM differ in their presentation and underlying physiology, they share many modifiable, lifestyle-related risk factors; including smoking, physical inactivity and poor diet [8,9]. These risk factors are more prevalent for people living in smaller and more remote locations [4]. Likewise, risk reduction strategies—such as smoking cessation, weight loss, exercise, improved health literacy, and greater health self-efficacy—are similar across many chronic diseases [10,11,12]. Earlier detection and reduction in risk factors can help slow progression, provide opportunities for intervention, and even prevent chronic diseases [9]. Exercise interventions are particularly effective for people with T2DM as they simultaneously address multiple aspects of metabolic health, improving glycemic control while reducing cardiovascular risk factors through enhanced vascular function and reduced inflammation [13].

The proliferation of comfortable and effective wearable devices offers promising new approaches for empowering individuals to monitor their own health and receive personalized feedback in real-time [14]. Rapid advances in technology have enabled the development of user-friendly devices that provide real-time, accurate biofeedback on activity levels, heart rate patterns, and other physiological parameters relevant to both T2DM management and CVD prevention [15]. Devices such as smartwatches with electrocardiograph (ECG) and photoplethysmography capabilities can simultaneously monitor multiple health metrics including heart rhythm, oxygen saturation, and physical activity levels. These technologies have the potential to facilitate more user-centered healthcare approaches by enabling individuals to track their own progress toward specific health goals, which can increase adherence to physical activity recommendations [15]. Such self-monitoring contributes to greater health literacy, health self-efficacy and autonomy [16]—benefits that are particularly relevant for Indigenous people in Australia who have expressed interest in using wearable health technology to learn more about and improve their health [17].

Co-design approaches in Indigenous health research vary significantly, ranging from collaborative consultation models to full community-controlled research designs [18]. Common approaches include co-production, co-creation, and participatory action research models, each with varying levels of community control [18]. Traditional co-design approaches often privilege researcher perspectives or limit community input to consultation phases rather than genuine power-sharing [18]. In contrast, best-practice co-design centers Indigenous ways of knowing and doing throughout the research process, addressing common challenges including power imbalances, tokenistic consultation, cultural misunderstanding, and institutional constraints [18,19,20].

While community-based clinician-supervised, group exercise interventions have demonstrated effectiveness in managing T2DM in non-Indigenous populations, evidence specific to Indigenous communities remains limited [21,22,23]. A recent systematic review [24] examining the effectiveness of community-based exercise interventions with Indigenous peoples managing T2DM globally identified only three studies [25,26,27] highlighting a critical gap between epidemiological research and translational interventions. The limited available evidence demonstrates that community-based exercise interventions can improve both physical and psychosocial health outcomes when conducted with strong community engagement and cultural safety [24]. Interventions achieve better participant engagement and more significant improvements in biomedical outcomes (including glycemic control, body mass index, total cholesterol, and blood pressure) and quality of life when they incorporate culturally safe program design, community health representatives, and removal of community-specific barriers to T2DM care [24]. However, a significant limitation across all studies was the lack of Indigenous governance structures in research design and implementation, emphasizing the need for future interventions to privilege Indigenous leadership and knowledge systems throughout the research process [24].

Despite the clear need for evidence-based, culturally adapted exercise programs for Indigenous people in Australia managing T2DM, none have appeared in the published literature to date. “Beat It”, developed by Diabetes Australia, is an evidence-based, eight-week clinician-supervised group exercise program that has demonstrated effectiveness in improving physical function and mental health outcomes for adults with T2DM in the general population [28,29]. Research has shown sustained long-term effectiveness of the Beat It Program, with health improvements of participants maintained at 12-month follow-up [30]. A recent qualitative study exploring the perspectives of Beat It clinicians identified eight key factors contributing to the program’s success: customization to individual needs, capability building, outcome improvement, affordability, accessibility, sustainability, and a holistic approach delivered in a group setting [31]. While Beat It has been successfully culturally adapted with priority populations, such as Chinese migrants in Australia [32], it has not been culturally adapted with Indigenous communities.

Although published evidence of Australian T2DM-specific programs designed with Indigenous populations is lacking, successful models have emerged in other health areas, with the culturally adapted Ironbark Falls Prevention Program demonstrating both significant physical function gains and high participant satisfaction among Indigenous Australians aged 40+ years [33,34,35]. This demonstrates the potential for culturally adapted exercise interventions to achieve meaningful health improvements in Indigenous peoples in Australia when developed through appropriate co-design processes.

The convergence of critical factors—the urgent need for T2DM interventions in Indigenous Australian communities, the effectiveness of community-based group exercise programs like Beat It, the emerging potential of wearable technology for health monitoring, and the evidence highlighting the importance of strong community engagement—presents a unique opportunity to improve health equity. The systematic review by Hurst et al. emphasizes that interventions must be adequately contextualized to culture through strong Indigenous governance and community engagement to achieve optimal outcomes [24]. In response to these needs and evidence gaps, we have developed the Preventing Indigenous CVD and Diabetes through Exercise (PrIDE) study—a co-designed intervention with Indigenous Australians that combines culturally adapted exercise and education programs with wearable technology monitoring.

2. Aim and Objectives

The aim of this research is to determine if wearable-based exercise interventions can effectively prevent CVD development and manage T2DM progression in Indigenous Australians with T2DM through culturally safe, community-led approaches.

• Objective 1: Co-design and develop culturally safe and acceptable, evidence-based exercise programs that utilize wearable technology to address T2DM management and CVD prevention for Indigenous participants.
• Objective 2: Evaluate the efficacy of two different wearable-based exercise programs on cardiovascular risk factors, physical fitness and health self-efficacy among Indigenous participants with T2DM.
• Objective 3: Identify implementation factors and resource requirements for scaling up successful wearable-based exercise interventions for Indigenous communities with high T2DM burden across regional, rural, and remote areas.

The PrIDE study will use existing evidence to improve CVD prevention and T2DM management outcomes through the co-design and delivery of community-led, sustainable strategies that can be scaled up.

3. Materials and Methods

3.1. Study Design

This mixed-methods translational research protocol will be conducted over one year and includes three phases. This study is designed as a pilot feasibility and implementation protocol to assess acceptability and feasibility, and to inform the design of future larger-scale trials. The PrIDE study incorporates Indigenous and Western research methodologies, bringing together an interdisciplinary team of experts in community and culture, co-design, Indigenous methodologies, cardiology, diabetes, digital health technology, health innovation scale-up and research translation.

The complete study implementation pathway is outlined in Figure 1, which demonstrates the flow from foundational governance structures through program delivery to knowledge translation.

The PrIDE study will be conducted in three phases. The first phase involves establishing the necessary foundations by co-designing a culturally adapted education and exercise program with assessment tools. The second phase focuses on implementation, which includes delivering a culturally adapted health education program and two exercise intervention options (group based supervised exercise and individual exercise programs) with wearable monitoring. The third and final phase encompasses evaluation and scale-up through data analysis, scale-up assessment and knowledge translation activities.

This co-designed implementation research integrates Indigenous and Western methodologies through long-standing community partnerships, citizen scientists and an iterative co-design approach underpinned by principles of universal design for learning (UDL) [36]. UDL was originally developed as a framework to guide the design of learning environments that are accessible, inclusive, and challenging for every learner, with the ultimate goal of supporting learner agency—the capacity to actively participate in making choices in service of learning goals. While extensively applied in education, there is growing recognition that UDL principles can be used in research design to increase inclusivity and accessibility, particularly for health research with priority populations where traditional approaches often design for dominant groups and retrofit for others—perpetuating power imbalances and limiting intervention effectiveness [37].

The PrIDE study applies UDL principles in research design, creating multiple pathways for participation rather than retrofitting for inclusion.

Table 1. Application of Universal Design for Learning (UDL) Principles in PrIDE Research Methodology.

UDL Guideline	PrIDE Implementation
UDL Principle 1: Multiple Means of Representation
Options for language and symbols	Culturally safe health education messaging; Multiple dissemination formats including plain English reports, in-person whole community meetings, and visual materials such as infographics and videos; Integration of Indigenous knowledge systems alongside Western methodologies; Privileging Indigenous ways of knowing and doing alongside biomedical approaches
Options for mathematical expressions and symbols	Visual wearable device displays; Real-time biofeedback through smartwatch; Graphical progress tracking via smartphone app; Multiple data representation formats to honor diverse interpretations
Options for comprehension	Yarning circles for knowledge sharing; Iterative co-design process for program adaptation; Authentic representation of community perspectives in research design
UDL Principle 2: Multiple Means of Engagement
Options for recruiting interest	Self-selection between individual vs. group programs; Choice of exercise activities in individual arm; Community-determined health priorities leading research direction
Options for sustaining effort and persistence	Weekly check-ins with research assistants; Real-time feedback through wearable technology; Cultural safety and belonging throughout program delivery; Fostering joy through culturally meaningful activities
Options for self-regulation	Risk reduction online quiz for personalized strategies; Individual exercise prescriptions; Self-monitoring through wearable devices; Community ownership and control of research processes
UDL Principle 3: Multiple Means of Action and Expression
Options for physical action	Choice between individual or group exercise programs; Accommodations for physical limitations; Multiple ways to engage in physical activity; Honoring diverse movement practices and traditions
Options for expression and communication	Yarning circles as culturally safe communication method; Qualitative interviews alongside quantitative measures; Community member involvement in data interpretation; Centering storytelling and oral traditions as foundational knowledge systems
Options for executive functions	Iterative co-design process allowing for ongoing input; Community governance structures and collective decision-making; Participant agency in program selection and goal setting; Interdependent learning and knowledge co-creation

demonstrates how these UDL principles are operationalized throughout the PrIDE methodology. By embedding UDL principles within this dual Indigenous-Western methodology approach, the research design will help to foster self-determination, deep community engagement, and autonomy—factors that contribute to better health outcomes for Indigenous populations [38] and are necessary to sustain positive outcomes from translational research.

3.2. Indigenous Governance

We will privilege Indigenous expertise and knowledge at three levels. First, we will establish overarching governance through the CHRI Consumer Advisory Group (CAG), which reviews research plans, methods, and findings to ensure they are consumer-focused, accessible, and meaningful, and oversees the Consumer User Panel (CUP). Second, our research team includes Indigenous Investigators whose expertise in culturally safe research methods guides the research, an Indigenous senior project manager, and Indigenous research assistants (RAs) who are involved in the day-to-day work of the project. Third, we will privilege local community knowledge and expertise through local Indigenous advisors who provide guidance and recommendations about the local context and culture to benefit the research [39].

The CHRI CAG, chaired by an Indigenous person, helps ensure research is consumer-focused, accessible, and meaningful. Members bring real-world perspectives and work together to shape research in ways that benefit the people who use it. The CAG consists of 7–11 members ensuring broad representation of consumer and user voices and meets quarterly to review research projects and oversee consumer involvement across CHRI research.

Additionally, a project-specific CHRI CUP will provide dedicated cultural oversight and community voice for the PrIDE study. The CUP is a key mechanism to ensure Indigenous Australian communities have both input and control in the research. The CUP will comprise 3–5 Aboriginal and/or Torres Strait Islander members. This panel will provide cultural guidance throughout the research lifecycle, including input into project design, community engagement, data interpretation, and results sharing. The CUP’s principal functions include providing feedback and advice on cultural issues in relation to the research, supporting community engagement strategies and ensuring local perspectives are included, reviewing participant materials for cultural safety and clarity, ensuring data use reflects community expectations and aligns with principles of Indigenous data sovereignty, and advising on sharing findings with ACCHOs, participants, and communities in culturally safe ways.

This dual-level governance structure is in keeping with best practices for health research with Indigenous communities and is required for ethics approval through the Aboriginal Health and Medical Research Council IN NSW (AHMRC). Additionally, we will establish partnerships with Elders, community members and staff working in Aboriginal Community Controlled Health Organizations (ACCHOs) to provide project-specific guidance and monitoring. This group will also include citizen scientists—non-academic research collaborators such as clinic staff and community members.

3.3. Patient and Public Involvement

The idea for the PrIDE study grew organically from multi-year partnerships with community partners who identified the need for effective approaches to prevent cardiovascular complications and manage T2DM for community members. These local ACCHO staff and community members will be actively involved in all phases of the research from design to dissemination.

3.4. Methodological Framework

We will use a validated approach to co-design research, the CHRI Model of Co-design based on collective impact (Figure 2) [19]. Co-design is critical to translational health research because health services intended for Indigenous people are more effective when customized to context and culture [40]. The CHRI Model of Co-design has five stages, is measurable and structured, and requires power and resource sharing [19]. These features align with the National Health and Medical Research Council (NHMRC) guidelines for conducting ethically sound research with Indigenous communities [20].

The CHRI Model of Co-design emphasizes the collective, rather than individuals or hierarchies, aligns well with respectful engagement and decision-making with Indigenous Elders and communities and has enabled significant and measurable improvement to seemingly intractable problems [19]. The CHRI Co-design Model considers sustainability from the outset to ensure long-term benefits for individuals and communities. The model privileges the perspectives and knowledges of Indigenous people and recognizes community contributions in ways that communities experience as meaningful and significant, including opportunities to participate as co-authors on publications and creating local employment opportunities and upskilling community members (e.g., Indigenous Research Assistants). In recognition of the principle of reciprocity and the value of participants’ time and knowledge sharing, vouchers will be provided to participants who complete surveys and participate in yarning circles. This approach acknowledges community expectations when contributing time to research and is a requirement for Aboriginal Health and Medical Research Council in NSW (AHMRC) ethics approval.

The co-design process will be facilitated through Indigenous research methodologies that adopt ways of knowing, being and doing central to Indigenous Australian cultures [41]. Yarning circles are an Indigenous Australian research method for conversation that involves storytelling and knowledge sharing. Yarning has been used in Indigenous Australian communities for thousands of years and is central to building respect, learning from each other equally and preserving cultural knowledge and tradition [42]. Unlike focus groups, yarning emphasizes establishing a level platform for knowledge exchange between all participants, recognizing each individual as expert in their own right, and promoting open sharing of experiences and ideas. This methodology supports cultural safety throughout the research process, which is essential for achieving health equity in Indigenous research [43].

3.5. Study Setting and Participants

The study will be conducted across remote and rural/regional sites in Australia, through partnerships with local ACCHOs. Eligible participants will be Australian Indigenous adults (≥18 years) who are diagnosed with or at risk of T2DM. Participants must be able to voluntarily consent to participate in the study and provide evidence of medical clearance to exercise from their general practitioner. Participants must be willing and able to participate in one of the two wearable-based exercise programs, complete periodic surveys and participate in yarning circles, and have regular access to an Apple smartphone (iOS 16.0+) or Android smartphone (Android 12.0+). Additionally, participants must be willing to wear the Withings ScanWatch 2 and download the Withings smartphone application. While access to a compatible smartphone is required, digital literacy is not an inclusion criterion for participation. All participants will be provided with the wearable device and receive structured, hands-on support from research staff during device setup and onboarding. Education regarding device use, interpretation of health data, and troubleshooting will be embedded within both intervention arms, with ongoing support available throughout the program. Individuals will be excluded if they are unable to provide informed consent or have medical contraindications to exercise participation.

We will recruit 64 participants in total (32 per study arm) across the participating sites. This sample size is appropriate for this pilot feasibility study and will provide adequate data for preliminary efficacy assessment and inform future larger trials. As a pilot feasibility study, this sample size is not powered for definitive hypothesis testing but is appropriate for assessing feasibility, acceptability, and generating preliminary estimates to inform future trials. ACCHO partners will refer eligible participants to the program. ACCHO staff trained in the study will invite eligible people to participate in the study. We will provide participants with descriptions of the two program conditions and invite them to select their preferred option while ensuring they understand the commitment required. This choice-based design honors participant self-determination and acknowledges that some participants may prefer individual approaches due to personal circumstances, comfort levels, or practical barriers, while recognizing that group programs align with Indigenous cultural values of collective activity [20].

3.6. Study Phases and Procedures

3.6.1. Phase One: Establishing the Necessary Foundations

As detailed in Figure 1, phase one focuses on developing the foundational elements necessary for culturally safe program delivery. The co-design team will deliver five outputs in parallel streams.

Output 1: Culturally Adapted PrIDE Exercise Program

An Indigenous Accredited Exercise Physiologist from the research team (author BBD) will adapt the original Beat It program for delivery with Indigenous Australian communities. The cultural adaptation will be systematically documented using the Model for Adaptation Design and Impact (MADI) framework [44], which provides a structured approach to assess and document adaptations while preserving the underlying mechanisms that make evidence-based interventions effective. The resulting documentation will detail all adaptations across key program areas, including AEP preparation, participant resources, assessment procedures, and delivery methods.

The adapted PrIDE program will be implemented according to the specifications established through the MADI process. Community feedback and ongoing program evaluation will occur throughout implementation to guide iterative refinements and inform future scale-up. Following evaluation, the complete MADI documentation will be published to provide visibility, transparency, and guidance for other researchers seeking to culturally adapt evidence-based interventions with Indigenous Australian populations. We have used the MADI tool for other adaptations of the Beat It program [29,32].

Output 2: Review and Cultural Critique of Evidence-Based Risk Factors

We will conduct a rapid literature review and render the findings in culturally safe, usable formats to share with ACCHO staff and community members. We will invite the co-design team to review and interpret the findings based on their lived experiences and priorities. Using an iterative approach, we will facilitate yarning circles with stakeholders to co-design a menu of evidence-based, culturally safe strategies to aid in T2DM management and CVD prevention.

Output 3: Risk Reduction and Strategy Selection Quiz

Based on the menu of evidence-based culturally safe strategies (Output 2), we will co-design and test an online quiz to help participants with T2DM select strategies from the menu that are most likely to suit them and guide their choice between the two study arms (group or individual exercise program). Using our iterative approach, the research team will provide a draft quiz and invite the co-designers to discuss and refine it. After each iteration, the draft will be tested with community members, and their input will be incorporated in the next round of co-design yarning circles.

Output 4: Culturally Adapted Health Education Sessions

The health education component serves as a critical complement to the exercise intervention, providing participants with knowledge and skills for T2DM self-management and CVD prevention [45]. We will culturally adapt the Beat It Education program using the CHRI Model of Co-design described in Section 3.4 [19]. Working with the CAG and CUP, along with community feedback through yarning circles, we will adapt educational content on lifestyle and T2DM management topics to ensure the materials reflect community priorities and cultural values [20,40]. Unlike traditional health education that follows predetermined curricula, our approach will use yarning methodology to create space for community knowledge sharing, two-way learning between participants and facilitators, and integration of traditional Indigenous health practices with contemporary diabetes management strategies [41,42]. This culturally adapted health education component will be documented within the MADI framework alongside other program adaptations [44].

Output 5: Culturally Adapted Health Self-Efficacy Tool

Using an iterative co-design approach with community member testing, we will adapt the 8-item New General Self-Efficacy (NGSE) self-efficacy tool [46] for assessing health self-efficacy for Indigenous people managing T2DM. This process will include refinement of language and administration using culturally appropriate yarning-based approaches, and assessment of content and face validity through community and CUP review prior to implementation. This iterative process to determine tool acceptability and validity is consistent with calls for using focus groups representing the target audience for tools [47,48], and it has been used to adapt the acceptability [49] and validity [50] of depression screening tools for Indigenous people in Australia.

These five outputs from Phase One represent the products that will be developed through co-design processes. Phase Two describes how these co-designed materials and programs will be implemented with participants.

3.6.2. Phase Two: Program Implementation

Phase Two focuses on the delivery and implementation of the programs and materials co-designed in Phase One. The intervention will be delivered over an 8-week period, aligning with the established Beat It program and supporting assessment of feasibility, acceptability, and short-term outcome responsiveness in a pilot context. Phase Two follows the structured implementation pathway shown in Figure 1, focusing on delivering the exercise interventions with wearable monitoring. Following eligibility screening, participants attend a registration day event where comprehensive baseline assessments are conducted as detailed in Figure 1.

Primary outcomes are grouped into three co-primary outcome domains—cardiovascular risk factors, physical fitness, and health self-efficacy—reflecting both biomedical and community-defined indicators of success in this pilot study. Physical assessments outlined in

Table 2. PrIDE Study Outcome Measures by Category, Domain, and Data Collection Method.

Outcome Category	Outcome Domain	Specific Measures	Data Collection Method
Primary Outcomes	Cardiovascular risk factors	Resting heart rate Blood pressure Waist circumference	Physical assessment administered by RA
	Physical fitness tests	30 s arm curl test (upper body strength) 30 s sit-to-stand test (lower body strength) Six-minute walk test (aerobic capacity) Timed one-legged stand test (balance) Chair sit-and-reach test (flexibility)	Senior Fitness Test battery [52] administered by AEP and RA
	Health self-efficacy	Culturally adapted NGSE scale	Self-report questionnaire administered by RA
Secondary Outcomes	Program feasibility	Adherence to intervention Attendance rates Completion rates	Administrative data and RA records
	Clinical monitoring	Atrial fibrillation detection incidents	Withings ScanWatch 2 data
	Physical activity	Active minutes per day Daily steps	Withings ScanWatch 2 data
	Program acceptability	Utility and comfort of the wearable device Accessibility, safety, comfort and inclusiveness of self-selected exercise program	Qualitative interviews and/or yarning circles with participants, RAs and AEPs
Process Outcomes	Scale-up readiness	ISAT [53] to assess scale up of community-based exercise and wearable program	Structured assessment tool with expert panel
	STARDIT reporting	Standardized documentation of initiative processes, stakeholder involvement, resource allocation, and outcomes using the STARDIT framework [54]	Member of research team will complete and upload to STARDIT Wikimedia platform for transparent, accessible reporting of research processes and findings

Note: AEP = Accredited Exercise Physiologist; ISAT = Intervention Scale-up Assessment Tool; NGSE = New General Self-Efficacy; RA = Research Assistant; STARDIT = Standardized Data on Initiatives.

are components of the Senior Fitness Test, developed by Rikli and Jones [51,52], a validated battery of functional fitness tests specifically designed for adults. These standardized assessments were selected based on their established validity and reliability for measuring functional fitness in adults and their direct relevance to daily living activities that support independent living. The assessments will be conducted by AEPs, who are university-qualified allied health professionals with specialized expertise in working with people across the full health spectrum, including those with chronic, complex conditions. Participants with injuries, recent surgery, or other physical limitations will be excluded from tests that are contraindicated or pose additional risk.

All participants will use the Withings ScanWatch 2, a medical device with Therapeutic Goods Administration (TGA) approval (493929). The Withings ScanWatch 2 was selected based on the following features: the ability to take an ECG, the battery life of 30 days, its attractive appearance and waterproofing, the ability to function at 25–40 °C, its reasonable cost, the scans it produces are billable to Medicare, and its ability to connect with a smartphone application available for both Apple and Android devices.

3.6.3. Phase Three: Evaluation and Scale-Up

As outlined in Figure 1, Phase Three encompasses comprehensive data analysis, scale-up assessment, and knowledge translation activities. Using the same co-design approach described in phase one, we will evaluate data and scale up our findings within the community and ACCHO context. Drawing on the outcome of this co-analysis, we will outline and publish recommendations for practice and policy changes.

The PrIDE research team will collaborate with a group of Indigenous and non-Indigenous experts in chronic disease, public policy, exercise, and health economics to conduct a scale-up assessment using the Intervention Scale-up Assessment Tool (ISAT) [53]. Additionally, the research team will complete comprehensive documentation of the PrIDE study processes using the Standardized Data on Initiatives (STARDIT) framework [54]. This will provide standardized, transparent documentation of stakeholder involvement, resource allocation, decision-making processes, and outcomes to support reproducibility and knowledge sharing for future implementations. Phase three will also include the publication of qualitative and quantitative findings in high-impact journals and the creation of plain English versions for distribution to community members.

3.7. Outcome Measures

All outcome measures are detailed in Table 2, including primary outcomes (cardiovascular risk factors, physical fitness, health self-efficacy), secondary outcomes (program feasibility and acceptability, clinical monitoring, physical activity), and process outcomes (scale-up readiness, STARDIT reporting).

3.8. Data Collection and Analysis

Data will be collected at baseline (pre-program assessment), weekly (wearable device data upload and progress check-ins), at 8 weeks (post-intervention assessment), and ongoing (qualitative yarning circles and process evaluation).

3.8.1. Quantitative Analysis

Quantitative data analysis will be performed using SPSS statistical software (version 30; IBM Corp., Armonk, NY, USA). Descriptive statistics will include mean and SD for continuous variables and frequencies and percentages for categorical variables.

For primary outcomes (cardiovascular risk factors, physical fitness, and health self-efficacy), within-arm pre–post change will be evaluated using linear mixed-effects models (LMMs) with a random intercept for participant and a fixed effect for time, fitted separately for each arm. To explore whether the programs differ in their average effect, we will fit a single LMM including both arms, with fixed effects for time, program arm, and their interaction (time × arm). The interaction term provides a descriptive estimate of any between-arm difference in change. Because participants self-select into program arms based on preference, between-arm comparisons will be exploratory and observational in nature. Baseline characteristics will be reported stratified by program arm to document any differences in participant characteristics between arms that may influence interpretation of between-arm comparisons.

Secondary outcomes (program feasibility and acceptability, physical activity levels from wearable devices, and clinical monitoring data) will be analyzed descriptively. Feasibility will be assessed through recruitment, retention, and adherence rates. Physical activity data from the Withings ScanWatch 2 will be summarized as means and trends over time. Clinical monitoring data, including atrial fibrillation detection incidents, will be reported descriptively.

3.8.2. Qualitative Analysis

Qualitative data from yarning circles and interviews (collected throughout the implementation) will be analyzed thematically using Indigenous research methodologies, with the co-design team, including Indigenous researchers and community members, centrally involved in data interpretation to ensure cultural authenticity and relevance [41,42]. The integration of quantitative and qualitative findings will be facilitated through the Indigenous governance structures, with community perspectives informing all conclusions and recommendations before dissemination [19,20].

All quantitative and qualitative analyses will be reviewed and interpreted with community partners, ensuring findings are understood within appropriate cultural and community contexts [20,41]. Co-design processes will be systematically documented using the STARDIT framework [54], including detailed records of yarning circle discussions, decision-making processes, and adaptations made based on community feedback. This documentation will be analyzed thematically using Indigenous research methodologies that honor oral tradition and collective knowledge creation [41,42].

3.9. Ethics, Data Management and Dissemination

Ethics approval for the PrIDE study has been obtained from the AHMRC (Approval #2479/25). The study will be conducted in accordance with the NHMRC guidelines for ethical research with Indigenous communities [20]. Participants will be de-identified, and community ownership of data will be respected through agreements with partner ACCHOs. Study findings will be disseminated through peer-reviewed publications in high-impact journals, presentations at Indigenous health and diabetes conferences, plain English reports for community members, social media and community champion communication programs, and policy briefs for health departments and ACCHOs.

4. Discussion

This protocol describes a comprehensive, culturally safe approach to co-designing and evaluating wearable-based exercise interventions with Indigenous Australians managing T2DM. The PrIDE study addresses a critical gap in the literature by combining the culturally adapted Beat It exercise program with modern wearable technology through a comprehensive co-design process that ensures Indigenous community ownership and governance throughout all research phases. This implementation approach is further supported by prior research from our team demonstrating that older Indigenous Australians engage with and derive value from digital health technologies, including wearable devices, when programs are designed and delivered in culturally safe ways [17].

The study’s strength lies in its methodological integration that values both Indigenous and Western research approaches. The CHRI Model of Co-design privileges community voices from initial design through dissemination, while Indigenous research methodologies including yarning circles ensure cultural authenticity. The systematic MADI documentation provides transparency for future adaptations. The selection of TGA-approved wearable technology offers innovative opportunities for real-time monitoring and potential early detection of cardiovascular complications such as atrial fibrillation. Additionally, this study will examine whether wearable technology can empower participants through self-monitoring and real-time feedback, potentially enabling them to learn about their own health patterns and progress, which may enhance health literacy, health self-efficacy, and autonomy in managing their health.

Although participation requires access to a compatible smartphone, the study design minimizes digital literacy barriers by providing the wearable device and structured, in-person support for setup and ongoing use. Education regarding device functionality and health feedback is incorporated into both intervention arms. As such, digital access considerations are mitigated within the current study design and are expected to be most relevant when considering future scale-up, where support structures may differ.

The non-randomized study design prioritizes participant choice and community control over experimental rigor, aligning with Indigenous research best practices that respect self-determination [20]. While this choice-based design honors participant autonomy and cultural values, we acknowledge that participant self-selection may introduce selection bias that limits causal inference strength compared to randomized designs. This represents a conscious methodological decision by the research team to balance internal validity considerations with ethical imperatives and cultural safety. This pilot feasibility approach, with embedded sustainability and scale-up assessment planning, is designed for preliminary efficacy evaluation to inform future larger trials while ensuring long-term community benefits.

The potential impact of the PrIDE study extends beyond immediate outcomes. By demonstrating successful cultural adaptation through co-design processes, PrIDE may provide a template for similar interventions across other health conditions and Indigenous communities. The systematic documentation through MADI and STARDIT frameworks will support future researchers, while the comprehensive outcome measurement approach balances biomedical measures with community-defined success indicators to provide thorough evaluation of both clinical efficacy and cultural safety.

5. Conclusions

The PrIDE study addresses a critical evidence gap by establishing the first culturally adapted, wearable-based exercise intervention co-designed with Indigenous Australian communities for T2DM management and CVD prevention. Through its commitment to co-design, cultural safety, and community ownership, this research has the potential to contribute meaningfully to improving health outcomes while advancing our understanding of how to effectively integrate wearable technology into Indigenous healthcare. The outcomes of this study will inform future larger-scale trials and policy development for Indigenous health interventions.