Type 2 diabetes mellitus (T2D) and metabolic syndrome (MetS) have reached epidemic proportions for Indigenous populations globally. In Australia, disproportionate rates of T2D and MetS are inextricably tied to the experience of colonisation. As part of a growing shift towards strengths-based, Aboriginal-led initiatives, this project sought to co-design and assess the feasibility of a metabolic remission initiative, whereby Aboriginal people living on Ngarrindjeri Ruwe (Country) are supported to adopt a low-carbohydrate diet.

This 28-week pilot takes the form of a non-randomised stepped-wedge design. Aboriginal adults (≥18 years) living on Ngarrindjeri Ruwe with T2D or MetS will be recruited to two sites in rural South Australia. Participants will transition through three phases (control phase, remission phase and maintenance phase) with repeated measures taken across five key time points (T1–T5). While centring on the adoption of a low-carbohydrate diet, participants will be equipped with continuous glucose and ketone monitors and meal boxes and offered ongoing support through weekly to fortnightly check-ins. The primary outcome is to assess the feasibility of Nra:gi Ya:yun in preparation for a large-scale clinical trial of similar design. Feasibility will be assessed through recruitment, retention and adherence rates. Self-reported dietary recall, out-of-pocket food costs and national pharmaceutical and medical benefits scheme data will also be examined. Qualitative data obtained using the Aboriginal research method of yarning will aid analysis and interpretation of results. Clinical measures (such as blood pressure, weight, waist circumference, capillary ketones and capillary glucose) and venous blood draws will assist in the evaluation of our secondary outcome, namely the initiatives’ preliminary effect on participant metabolic health.

Findings will be disseminated to Community, participants and policymakers in the form of digital posters, manuals, infographics and peer-reviewed publications. Lessons from this study have the potential to provide insights and benefits to Australian public health policy and research, as well as Indigenous populations globally who face similar metabolic challenges. Findings will be used to advise on an implementation strategy for a large-scale clinical trial. Pilot trial approved by the Aboriginal Health Research Ethics Committee (HREC), Flinders University HREC and Southern Adelaide Local Health Network HREC.

Pilot prospectively registered with the Australian and New Zealand Clinical Trials Registry ACTRN12624001019594.

To investigate the scalability of the multi-component Falls After Stroke Trial (FAST) intervention tailored to community-dwelling adults with stroke to enable post-trial implementation.

A mixed-methods formative evaluation of FAST data guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.

Community settings across three states in Australia.

Stroke participants were a subset of FAST trial participants (n=50) who were community-dwelling adults who had experienced a stroke up to 5 years prior and were at risk of falling. Therapists who delivered the intervention in the trial (interventionists) were physiotherapists and occupational therapists, trained in the FAST intervention.

The FAST intervention is an individually tailored home safety and functional exercise programme designed to reduce falls and improve community mobility. It is offered over a 6-month period using 10 home visits, two telephone calls and programme resources, for example, manual and worksheets.

Trial data, including interventionist training records and delivery data, resources and stroke participants’ adherence data were used to assess the Adoption, Implementation and Maintenance dimensions of the RE-AIM framework.

The FAST intervention was delivered by 22 interventionists. High implementation fidelity was shown with 90% of the stroke participants receiving FAST dose and content. Effective strategies supporting implementation included standardised programme resources, comprehensive pre-programme training, regular interventionist feedback and interventionist mentoring from experts. Online training and peer support networks will be required for scale up.

This study identifies how a complex intervention to prevent falls after stroke was successfully delivered. The AIM dimensions provided insights to FAST features essential for scale-up. Interventionist training, resources and mentoring/feedback were essential for adoption within the trial. Training and resources should be accessible in an online format for scale up (maintenance).

ACTRN12619001114134.