BRAIN-Diabetes: a randomised trial to test the feasibility of an adapted FINGER multidomain intervention in adults with type 2 diabetes living in rural border regions of Ireland

Background: The Border Region Area lifestyle INtervention for healthy cognitive ageing in Diabetes’ (BRAIN-Diabetes) trial aimed to test the feasibility of an adapted version of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) multidomain intervention in cognitively healthy adults at risk of dementia living in border regions of Ireland. Methods: BRAIN-Diabetes was a 6-month randomised controlled pilot trial involving adults living in rural border regions who were ≥ 50 years old, without existing dementia but had a diagnosis of type 2 diabetes and access to a computer. Individuals were randomised to either the multidomain intervention or the standard care control group. The intervention included diet counselling, physical exercise and computerised cognitive training which were delivered remotely and cardiometabolic risk monitoring which was delivered in person. The primary outcomes assessed feasibility of recruitment/retention and adherence to the intervention. Other outcomes explored intervention effects on cognitive, metabolic and health-related quality of life. Results: In total, 156 individuals were assessed for eligibility, and 79 (51%) were recruited (mean age 61.6 ± 6.9 (range 60–75) years; 68% male). After 6 months, retention was 81% (72% in intervention versus 90% control). Adherence rate was high with most participants attending > 50% of the scheduled intervention sessions. There was greater improvement in diet quality (p < 0.001), daily step count (p = 0.04), triglyceride levels (p = 0.02) and health-related quality of life (p < 0.05) in the intervention group compared to control. There were no observed intervention effects on cognitive performance over 6 months. Conclusions: The BRAIN-Diabetes pilot trial demonstrated that an adapted FINGER model was feasible to deliver and efficacious in supporting lifestyle behavioural changes among a unique at-risk rural population. There were also indicative benefits for metabolic health and health-related quality of life over a short time frame. Trial registration ClinicalTrials.gov (registration ref: NCT05304975 accepted 31st March 2022).