Name of Study
BRAIN-Diabetes: Border Region Area Lifestyle Intervention study for healthy Neurocognitive ageing in diabetes.
Purpose of Study (300 words)
This is a research study taking place locally for people with type 2 diabetes. The researchers are examining ways of supporting lifestyle and behaviour change for brain health that people with diabetes think are helpful.
The objective is to evaluate a culturally tailored adaptation of The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) protocol targeted for individuals with Type 2 diabetes mellitus (DM) living in the border areas of Ireland.
The primary research question to be addressed is; what is the feasibility and acceptability of implementing a multicomponent intervention for the target population in a community setting in comparison to standard clinical care. The study protocol was informed by a phase 1 qualitative study (REC ref 19/NI/0011) involving the target population i.e. older people with Type 2 DM from the border areas of N Ireland and the Republic of Ireland and has been amended (version 2.0) in response to the coronavirus pandemic.
Type of Study (observational/exploratory etc)
Exploratory
Are you recruiting participants for this trial?
Yes
State geographical location of study (city/county/country) (single or multiple sites)
Sligo Leitrim West Cavan, Sligo Site SLIGO UNIVERSITY HOSPITAL. Enniskillen and South Western Area Hospital, (SWAH-catchment Tyrone/Fermanagh).and South Western Area Hospital, (SWAH-catchment Tyrone/Fermanagh).
Who can take part?
Sligo Leitrim West Cavan and Tyrone/Fermanagh).
What will the participants be asked to do? (max 300 words)
A total of 140 (70 from Sligo/Leitrim/West Cavan and 70 from Tyrone/Fermanagh) non-demented individuals aged ≥ 50 years within 5 years of Type 2 DM diagnosis will be recruited. Those eligible and willing to take part will give informed written consent, and will be randomized (randomization scheme generated using www.randomization.com with random block sizes and research staff administering the randomization or conducting endpoint assessment blinded) to either intensive lifestyle intervention or control (35 participants in each group in each site). All participants will receive general information on brain health in DM at baseline.
Participants randomised to control group will receive standard clinical care and be provided with pedometers to wear to record their walking activity while those randomised to the intensive lifestyle intervention will receive a community-based multicomponent programme involving a 4-month active intervention delivered online, followed by a 2-month self-directed consolidation stage. The 4-month active intervention will involve online delivery of the following components:
1. Diet: The Diet intervention will be delivered remotely. Participants will be provided with written dietary education, meal plan, recipe ideas, tips and suggestions at their baseline study visit. Participants will then meet online with the study nutritionist for around 90 minutes for personal dietary advice. Dietary advice will be based on the latest evidence from the nutrition-dementia field and encompass recommendations from the MIND (Mediterranean-DASH diet Intervention for Neurodegeneration Delay) diet tailored for the target population16.The nutritionist will support participants to set personal dietary goals and to monitor progress in changing towards the MIND diet. If weight loss is indicated, the nutritionist will also advise energy intake to facilitate 5–10% of body weight reduction. Following the initial appointment, review meetings with the nutritionist will take place monthly in the first four months, either online or by telephone (according to participant preference) and lasting up to 60 minutes. Each diet review meeting will include:
(i) Education on the main MIND diet components. The required frequency and amount of key foods will be reinforced and progress in making the recommended dietary changes will be discussed.
(ii) Individual assessment and feedback- The nutritionist will review individual progress and clarify any issues arising in meeting personal goals and/or study educational material received by the participant.
| A total of 140 (70 from Sligo/Leitrim/West Cavan and 70 from Tyrone/Fermanagh) non-demented individuals aged ≥ 50 years within 5 years of Type 2 DM diagnosis will be recruited. Those eligible and willing to take part will give informed written consent, and will be randomized (randomization scheme generated using www.randomization.com with random block sizes and research staff administering the randomization or conducting endpoint assessment blinded) to either intensive lifestyle intervention or control (35 participants in each group in each site).
All participants will receive general information on brain health in DM at baseline. Participants randomised to control group will receive standard clinical care and be provided with pedometers to wear to record their walking activity while those randomised to the intensive lifestyle intervention will receive a community-based multicomponent programme involving a 4-month active intervention delivered online, followed by a 2-month self-directed consolidation stage. The 4-month active intervention will involve online delivery of the following components: 1. Diet: The Diet intervention will be delivered remotely. Participants will be provided with written dietary education, meal plan, recipe ideas, tips and suggestions at their baseline study visit. Participants will then meet online with the study nutritionist for around 90 minutes for personal dietary advice. Dietary advice will be based on the latest evidence from the nutrition-dementia field and encompass recommendations from the MIND (Mediterranean-DASH diet Intervention for Neurodegeneration Delay) diet tailored for the target population16.The nutritionist will support participants to set personal dietary goals and to monitor progress in changing towards the MIND diet. If weight loss is indicated, the nutritionist will also advise energy intake to facilitate 5–10% of body weight reduction. Following the initial appointment, review meetings with the nutritionist will take place monthly in the first four months, either online or by telephone (according to participant preference) and lasting up to 60 minutes.
Each diet review meeting will include:
2. Physical Activity: The exercise intervention will be delivered remotely. Participants will undergo a physical performance assessment at the baseline study visit and receive a home exercise written resource that has been designed for older adults (ExWell@home) and adapted for the current study. It is expected that participants will begin with a basic level of exercise that will increase in frequency and intensity over the first 4 weeks to reach a core required level. There will be the option of more intensity to the programme for those at higher levels of baseline fitness. In week one, participants will meet online with the Physiotherapist /Exercise Instructor. for around 60 minutes to plan a personalised exercise programme combining mixed aerobic and strengthening exercises in an interval training format and based on their baseline assessment. The physiotherapist /Exercise Instructor will explain the basics of exercise prescription, the foundations of the personal home programme and safety aspects.
The Physiotherapist/Exercise Instructor will facilitate appropriate exercise goal setting and demonstrate the exercises within the personal programme. Participants will be advised to wear the study pedometer to record their walking activity and complete the exercise diary to record overall step count and daily exercise. Participants will also be provided with links to video demonstration of the exercises (strength / aerobic / core stability and balance)The Physiotherapist /Exercise Instructor will review individual progress in meeting personal goals on a weekly basis either online or by telephone according to participant preference.
3. Cognitive stimulation: This component will be delivered using Brain HQ® (Posit Science), a computer based cognitive training platform, which utilises visuospatial and auditory games to enhance attention, mental processing speed, learning, memory, and low mood. On 2 occasions during the first month participants will receive a 30-60min Brain HQ® cognitive training session delivered by a trained instructor either online or through attendance at a HSE venue the Benbulbin Chronic Disease Management Hub.
The aim of training is to familiarise participants with various games and program processes to optimise engagement with the home programme. Additional training support will be scheduled if requested by study participants. Brain HQ® cognitive training application will be available to download on a range of devices including laptop, desktop and tablet according to participant preference. There will also be a SMART phone application for participants with limited/no computer access. Following training, participants will be asked to log in at home and complete the cognitive training session at least 4 days per week. Each session is expected to last 30 minutes.
Recruitment Start Date 26/07/2021 Recruitment Finish Date 31/01/2022 Study Duration 6 Months This study is funded by: The research is being sponsored by Queen’s University Belfast. 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 members of the research team will not receive any payments for including you in this study.
For further information contact: Caroline Bradshaw . Research Coordinator at 0874565851 Phone 087 4565851 NAME – completed this form Caroline Bradshaw Ethical Approval & Relevant Documents & Logo’s Approval-Letter-ethics-second-phase-recd-by-CB-Jan8-2020.pdf |
