UCalgary-led research highlights new model for culturally safe Indigenous clinical trials

A University of Calgary-led clinical trial exploring whether healthy food incentives can improve the health of people living with diabetes and food insecurity has also demonstrated a new approach to making research involving Indigenous communities more culturally safe.

A recent paper published in the Canadian Medical Association Journal (CMAJ) evaluates an Indigenous-led advisory model developed to guide the FoodRx randomized controlled trial, led by UCalgary researchers including Dr. Dana Olstad, PhD; Dr. David Campbell, MD, PhD; Dr. Reed Beall, PhD; and Dr. Eldon Spackman, PhD, in collaboration with researchers across Canada.

The advisory board, All My Relations (AMR), was co-created by Dr. Richard Oster, PhD, scientific director of Primary Care Alberta's Indigenous Wellness Core and a University of Calgary researcher, and Kienan Williams, a PhD student in the Department of Community Health Sciences at the Cumming School of Medicine and the program lead, innovation and research for Primary Care Alberta. 

Bringing together Indigenous Elders, scholars, health-care providers and people with lived experience of diabetes, as well as non-Indigenous health-care providers and researchers, the board provided guidance throughout the FoodRx study to help ensure the research reflected Indigenous perspectives and was conducted in a culturally safe and respectful way.

The CMAJ paper identifies four interconnected elements that contributed to culturally safe clinical research: culture and ceremony, a transformative research environment, Indigenous ways of knowing, and equitable partnerships.

"The AMR board's guidance, rooted in the wisdom of the Elders, was essential to ensure cultural safety and respect, and to establish meaningful participant engagement in the FoodRx randomized controlled trial," the authors write.

"This is the strongest contribution to randomized controlled trials from an Indigenous lens that I have seen," says Williams. "I feel proud to be an Indigenous-embedded health researcher supporting work of this innovative nature."

Oster says the model recognizes that meaningful engagement with Indigenous communities requires time, trust and relationship building.

"Using an approach like this and building relational accountabilities means going at the pace of trust," he says. "It takes time."

The FoodRx trial examined whether providing participants living with diabetes and food insecurity with $10.50 in grocery loyalty points per household member each week could improve food security and blood sugar levels. 

Conducted in Alberta for 12 months between 2021 and 2022, the study enrolled 596 participants, including 73 Indigenous participants — approximately 13 per cent of the study population, well above the proportion of the Canadian population. Results from the study have not yet been published. 

Food insecurity affects approximately one in four Albertans and is associated with poorer health outcomes, making it an important area of study for researchers seeking equitable approaches to chronic disease prevention and care.

The Indigenous advisory model was supported through funding from the MSI Foundation, while the FoodRx trial received funding from Alberta Innovates, Alberta Health Services and Alberta Blue Cross.