BRAIN-Diabetes (Ireland)

The BRAIN-Diabetes study (Border Region Area lifestyle INtervention study for healthy Neurocognitive ageing in diabetes) 

The BRAIN-Diabetes pilot trial tested the feasibility of an adapted version of the FINGER multidomain intervention in cognitively healthy adults diagnosed with type 2 diabetes in rural regions of Ireland. The pilot demonstrated that it is feasible to implement an adapted FINGER model in the targeted population and that it supports lifestyle behavioural changes. COVID-19 affected the trial plans, and shortened the intervention period to 6 months. There were indicative benefits for metabolic health and health-related quality of life among the participants, but the trial period was too short to detect changes in cognitive performance.

Latest page update: 7 January, 2026

Aim of the project

To test feasibility of an adapted version of FINGER among older adults with type 2 diabetes living in rural border regions of Ireland.

Location

Recruitment from two rural areas:
one in Northern Ireland (NI) (covering Tyrone/Fermanagh border area) and one in Southern Ireland (RoI) (covering Sligo/Leitrim/West Cavan border area).

Local setting

BRAIN-Diabetes was originally planned as a 12-month feasibility RCT. The COVID-19 global pandemic caused recurrent lockdowns nationwide during 2020–2021 forcing delay to start the study. Some adjustments were deemed necessary to ensure safety of participants.

• The group-based activities were removed from the intervention, and the diet, exercise and CCT components were redesigned to be delivered remotely at home.
• Follow-up time was shortened from 12 to 6 months in order to meet the timeline for deliverables with the available budget.

Organizations involved

Leading: Queen’s University Belfast
Collaborators: Western Health and Social Care Trust

Principal Investigator (PI)

Peter Passmore, Queen’s University Belfast

Research team

Claire McEnvoy, Queen’s University Belfast

Duration of the project

Duration of the intervention

Project start date

Project end date

Current stage of the project

Completed

Number of study participants

Target population

Adults who were ≥50 years old, with type 2 diabetes and access to a digital device

Outcomes

Primary outcome

• Feasibility of recruitment and retention, and adherence with intervention components

Exploratory outcomes

• Global cognitive performance (NTB global and subdomains)
• Metabolic health measures (BMI, blood lipid profiles and HbA1C level)
• Health related quality of life
• Acceptability

Intervention

Intervention domains

• Dietary counselling: based on the MIND diet.
• Physical exercise: Participants received a personalised home-based exercise programme combining aerobic, strengthening and balance exercises based on their baseline physical function. They were provided with a written resource designed for older adults (ExWell@home), links to video demonstration of the exercises (strength/aerobic/core stability and balance), links to online exercise classes, light dumbbells.
• Cognitive training: delivered using the Brain HQ software.
• Cardiometabolic monitoring

Qualitative research was conducted with the target older adults with type 2 diabetes living in the rural border regions of Ireland. This work revealed several barriers including cultural food norms and low self-efficacy for behavioural changes. This work helped to inform the adapted FINGER model.

Results

Primary outcomes

• After 6 months, overall retention was 81% (72% and 90% in intervention and control groups, respectively)
• Attendance was highest (> 90%) for cardiometabolic monitoring visits and with the scheduled diet sessions.
• Adherence was lowest to the Cognitive training schedule, with just over half the sample completing 50% or more of the expected sessions at home.
• There was a greater shift to a brain healthy diet in participants in the intervention group compared to control group.

At 6 months, daily step count increased more in the intervention group than the control group with intervention participants achieving ~ 9 k/day (target ~ 10 k/day)

Exploratory outcomes

• The intervention and control groups had small improvements in BMI and HbA1c.
• Those in the intervention group improved triglyceride level, total cholesterol–HDL ratio as well as physical and mental HR-QoL domains.
• Both intervention and control group showed better cognitive performance after 6 months, but there was no indication that the intervention group performed better.

The main findings were that the trial was feasible to deliver and efficacious in supporting individual lifestyle behavioural changes.

Nevertheless, these results should be interpreted cautiously as BRAIN-Diabetes was not powered to detect effects on secondary endpoints and the short trial duration of 6 months is unlikely to be long enough to detect changes in cognition.

People with T2D were disproportionally at risk of serious complications from COVID-19 infection and advised to stay at home, which led to marked decreased attendance for routine clinical care as well as participation in research activities.

Acknowledgements

This study is funded by the HSC R&D Division Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN) programme, funded by the European Union’s INTERREG VA Programme, managed by the Special EU Programmes Body (SEUPB) project reference CHI/5431/2018.