BRAIN-Diabetes: Version 1
Research type
Research Study
Full title
BRAIN-Diabetes: Border Region Area lifestyle Intervention study for healthy Neurocognitive ageing in diabetes
IRAS ID
255316
Contact name
AP Passmore
Contact email
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
People with diabetes mellitus (DM) have approximately three times higher risk for dementia. There is an opportunity to intervene with prevention strategies to reduce risk of memory decline/dementia. A lifestyle intervention study called FINGER (older Finnish adults at higher risk for dementia) showed an intensive programme based on improving nutrition, exercise, cognitive stimulation/social activities and control of vascular risk factors, significantly benefited memory function after 2 years. FINGER was extremely intensive with concerns about general applicability. Further studies are needed to test whether lifestyle programmes designed to improve brain health are feasible and effective.
This study will assess feasibility of a practical modification of FINGER delivered in a community setting, in older individuals with Type 2 DM living in border areas of Ireland. The study will have 2 phases. Phase 1 will last 3 months and involve patients with DM to design the nature of the lifestyle components that will be tested.
In Phase 2 a total of 140 (70 from Sligo/Leitrim/Cavan and 70 from Tyrone/Fermanagh) non-demented individuals 60 years and older, within 18 months of DM diagnosis will be randomized (35 in each group in the 2 sites) to the intensive lifestyle programme or standard care for 4-months followed by a 2-month self-directed consolidation stage. Participants will be assessed at baseline and then 4, 6 and 12 months to undergo tests of memory, general health and assessments of lifestyle behaviours including diet and exercise.
We will assess acceptability and feasibility of the interventions at 4, 6 and 12 months using questionnaires as well as interviews at the end of the study with all willing study participants. The results will enable us to design a larger study to fully test whether the lifestyle intervention is effective for brain health.REC name
HSC REC A
REC reference
19/NI/0011
Date of REC Opinion
25 Feb 2019
REC opinion
Further Information Favourable Opinion