Name of Study
BRAIN-Diabetes: Border Region Area lifestyle Intervention study for healthy Neurocognitive ageing in diabetes.
Purpose of Study
This study aims to develop a healthy brain lifestyle programme for people with Type 2 Diabetes Mellitus (T2DM) in the border areas of Ireland. The lifestyle programme to prevent cognitive/memory impairment and dementia will include exercise, diet, brain (cognitive) training and management of vascular risks, e.g. high blood pressure.
For the initial part of the study, we need participants to participate in focus (discussion) groups. The aims of these focus groups are to (i) explore the attitudes of people with T2DM towards changing their lifestyle to reduce the risk of cognitive impairment and dementia and, (ii) to determine what type of lifestyle programme would be acceptable to people with T2DM to encourage lifestyle change.
For the second part of the study, we require participants to take part in a healthy brain lifestyle intervention (participant will be randomised to one of two different types of intervention).
Study participants must have T2DM, be aged 60 years or over and reside in the Sligo/Leitrim/West Cavan/Fermanagh/Tyrone area.
Type of Study (observational/exploratory etc.)
| The initial part of the study is a qualitative study, and the second part is a clinical trial to evaluate the feasibility and acceptability of a lifestyle intervention to reduce the risk of cognitive impairment and dementia in older adults |
Are you recruiting participants for this trial?
Yes
Geographical location of study
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Who can take part?
| Study participants must have T2DM, be aged 60 years or over and reside in the Sligo/Leitrim/West Cavan/Fermanagh/Tyrone area. |
What will the participants be asked to do?
| Focus group participation: If you decide to take part you will be asked to participate in a group discussion with approximately 7 other people. This discussion will cover topics such as what forms of support might help people with diabetes to make recommended changes to improve diet, increase physical activity, and boost brain stimulation via computerised brain training. The information we obtain from these discussions will be used to guide the development of a healthy brain intervention. Participants will be allocated to either a group who receive a lifestyle programme or a control group who receive education and standard care. The lifestyle group will receive a 4-month active lifestyle programme in the community followed by 2 months of engaging in a self-directed lifestyle programme. |
Recruitment Start Date
24/05/2019
Recruitment Finish Date
31/03/2020
Study Duration
| Focus group: The group discussion should take no more than 1.5 hours and will take place in an agreed and convenient location (E.g. Sligo University Hospital). Travel expenses associated with this group discussion will be reimbursed. Lifestyle study: The lifestyle programme lasts 6 months. Participants will be assessed at baseline, 4, 6 and 12 months. |
This study is funded by:
| Research funding is provided by the Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN) with funding partners HSC Public Health Agency, Interreg and the Health Research Board. The research is being sponsored by Queen’s University Belfast. |
For further information contact:
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Phone
| 091494652 |
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