Brain Diabetes main study
Research type
Research Study
Full title
BRAIN-Diabetes: Border Region Area lifestyle Intervention study for healthy Neurocognitive ageing in diabetes. A feasibility randomised controlled trial
IRAS ID
280495
Contact name
AP Passmore
Contact email
Sponsor organisation
Queens University Belfast
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
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. An initial phase of the study has completed and involved patients with Type 2 DM to help design the nature of the lifestyle components that will be tested.
In this study 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 9 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 9 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.Summary of results
At the end of the 6-month study period the overall attrition rate was less than 20% (19%). After 4 months, there were retention rates of 76.9%, and 85.0% in the intervention and control groups respectively. This led to an overall retention rate of 81% at 4 months. After 6 months, there were retention rates of 71.7% and 90.0% in the intervention and control groups respectively which led to an overall retention rate of 81% at 6-months. There was significantly greater shift to a brain healthy diet in the intervention compared to control group (p<0.0004) as shown in Figure 4.2. Intervention participants increased their MIND diet score by 3 points at 4 months which was maintained at 6 months to achieve the intervention target of 2 or more points. At 6-months there was no between group difference in daily step count. However, intervention group participants had increased their step count to ~10k/day while there was no change in the control group There was no significant between or within group change in the cognitive composite scores for global cognition, memory or executive function over 6-months At 6-months, there were small improvements in weight, BMI and HbA1C that were of greater magnitude in the intervention group than the control group (Table 4.3; Figure 4.4), but the between group differences were not significant. There was a significant between group difference in blood triglyceride levels with the intervention group having a mean reduction of 0.4mmol/l versus an increase in 0.3mmol/l in the control group (p=0.02). There were also improvements for intervention participants in both the physical and mental health domain scores in the SF-36 Quality of life questionnaire which worsened in the control group Despite the challenges experienced in relation to covid-19 pandemic, we demonstrated that Brain-Diabetes is both feasible for community implementation and to support behaviour change. The feasibility criteria for proceeding to large scale intervention were satisfied despite the reduced timeframe for recruitment. The intervention increased adherence to the MIND diet and increased step count to meet the intervention goals. While we were not powered to detect changes in cognitive and health measures, there were indications of improved metabolic health outcomes as well as mental and physical health scores that are clinically important and important to this patient cohort.
REC name
HSC REC A
REC reference
20/NI/0051
Date of REC Opinion
22 May 2020
REC opinion
Further Information Favourable Opinion