None listed
Conditions
Brief summary
This project is an Aboriginal led, non-randomised pilot to evaluate a co-designed initiative entitled 'Nra:gi Ya:yun' (NY), developed during the formative phase of the wider Coorong Diabetes Collaborative (CDC) study. NY is a healthy eating initiative with the objective of reducing the prevalence of type 2 diabetes and metabolic syndrome in Aboriginal people living on Ngarrindjeri Country. The aims of this pilot study are two-fold. Firstly, to assess the feasibility of the Nra:gi Ya:yun initiative with Aboriginal people living on Ngarrindjeri Ruwe, to inform the implementation of a large-scale trial. Secondly, to determine the preliminary effects of the initiative on participant metabolic health. Adopting a stepped-wedge study design, consenting participants will be assigned to a cluster (group) as NY is rolled incrementally across two sites.
Interventions
28-week non-randomised stepped wedge pilot, consisting of 2 sites (3 clusters) with 3 phases: a control phase, a remission phase, and a maintenance phase (ongoing). Each cluster will serve as its own control, initially experiencing a 4-week period of monitoring but no exposure. Exposure to the fixed 12-week remission phase will be staggered by cluster on a fortnightly basis. The remission phase is considered the active phase of the trial, whereby participants will be supported to adopt a ketogenic diet. For the duration of the 12-week remission phase participants will have access to the following: 1) Continuous glucose and ketone monitoring (CGM/CKM) devices to encourage motivation, compliance and ensure up-to date information is provided to program staff. 2) A tablet, linked to digital Point of Care Testing (POCT) equipment to measure blood pressure, temperature, pulse and oxygen saturation. This daily POCT will include questions on CGM/CKM discomfort and e-yarns on wellbeing. Time required is less than 10 minutes. Results uploaded automatically, accessible to participants and program staff. 3) Weekly monitoring by clinical staff (experienced GP and endocrinologist). Program Leads (PLs) will be supported by clinical investigators to measure blood pressure, weight, waist circumference, capillary ketones and HbA1c (digital monitors) on weekly to fortnightly basis. Weekly clinical monitoring informed by the daily CGM/CKM readings, daily POCT results, weekly or fortnightly physiological measures and blood tests recorded at T1-T5. Participants will triaged to, A) our clinical team for remission, B) GP/ED for other clinical standard of care, or C) our project staff for support/coaching issues. 4) Weekly supply of ketogenic meal boxes containing subsidised ingredients for 2 meals per day, catering for individuals and their families. 5) Weekly to fortnightly yarning check-ins and support sessions on remission progress, challenges etc. with Program Leads (PLs) and the Diabetes Project Manager (DPM). The length and mode of each session (i.e. in person or over the phone) will be directed by the participant themselves as program staff adopt a participant-centred approach. 6) Fortnightly 1-hour gatherings (education or physical activity) held on Country at site locations, facilitated by PLs and the DPM, focusing on community concerns raised during the formative co-design phase of the study. Dictated by community interest, sessions will be repeated as required. 7) Incremental remission journey resources from Week 1 of remission phase containing program infographics such as a keto food pyramid, pantry list, meal plans, recipes, and sorry business navigation. Participants will have access to electronic versions if so desired. We envision the development of a program book, with all relevant resources collated throughout the program. 8) Online support for those who cannot attend in person (i.e. due to work, family/caring commitments, transportation access). Participants will receive electronic versions of the resources and short videos reviewing key content delivered during fortnightly gatherings. During the maintenance phase, access to above intervention components is slowly reduced. A staggered transition was designed to empower participants to continue their T2DM and metabolic syndrome remission journey, with sustainability of health outcomes in mind. Meal boxes will not be supplied, as participants source relevant ingredients independently, supported by program staff. Participants will retain access to CGM/CKM patches and POCT equipment for the first two weeks of the maintenance phase. Fortnightly gatherings offered during the remission phase will continue but transition towards community-led, informal gatherings facilitated by PLs from the local health network. The intent is for community to take ownership of the process, directing the future content and structure of the gatherings. Online supports will similarly be community-directed during the maintenance phase. Participants will have the choice of continued access to online and/or in-person gatherings or to transition away during this final phase. It is anticipated that by the end of the maintenance phase, participants will be equipped with the appropriate knowledge, resources, and support to maintain their remission independently.
Sponsors
Study design
Eligibility
Inclusion criteria
Aboriginal person living on Ngarrindjeri country, aged 18 years or over, records measurements consistent with type 2 diabetes (HbA1c levels greater than or equal to 6.5%A1c) or metabolic syndrome (defined by meeting 3 of 5: abdominal obesity, hypertension, insulin resistance, raised triglycerides, decreased HDL cholesterol).
Exclusion criteria
*Pregnancy *breast feeding women *Type 1 diabetes *End stage liver failure or undergoing dialysis *T3cD (primary pancreatic disease) *Insulin deficient diabetes *self-reported eating disorders (anorexia, nervosa, bulimia) *On SGLT2 inhibitors for reasons other than diabetes (i.e. renal disease or heart failure)