Border Region Area Lifestyle Intervention Study for Healthy Neurocognitive Ageing Diabetes

Summary

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

Conditions

• Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

diet

Participants will be provided with written dietary education, meal plan, recipe ideas, tips and suggestions at their baseline visit. Participants will then meet online with the study nutritionist for around 90 minutes for personal dietary advice which will be based on the latest evidence from the MIND (Mediterranean-DASH diet Intervention for Neurodegeneration Delay) diet tailored for the target population. 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% 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 and lasting up to 60 minutes

BEHAVIORAL

cognitive stimulation

Cognitive stimulation will be delivered using Brain HQ® (Posit Science), a computer based cognitive training platform, which utilises 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 training. The aim is to familiarise participants with games and program processes to optimise engagement with the programme.The cognitive training application is available to download on a range of devices. Following training, participants will be asked to log in and complete the training session at least 4 days per week. Each session is expected to last 30 minutes. Individual cognitive training performance will be recorded centrally. Participants will receive feedback of percentage improvement in performance. The program allows remote monitoring of frequency of use and engagement. Therefore, performance, frequency, duration, and type of use will be recorded centrally throughout the study period

BEHAVIORAL

physical activity

The exercise intervention will be delivered remotely. Participants will undergo a physical performance assessment at baseline and receive a home exercise written resource that has been designed for older adults 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. In week one, participants will meet online with the trained exercise instructor for around 60 minutes to plan a personalised exercise programme. The instructor will explain the basics of exercise prescription, the foundations of the personal home programme and safety aspects. The 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.

OTHER

risk factor management

Metabolic and vascular risk factor management. At each study visit (baseline, month 4, month 6 and month 9), participants will be informed by the research nurse about their blood results, weight and blood pressure and will receive recommendations to visit their GP to change treatment as necessary

Sponsors & Collaborators

• Western Health and Social Care Trust

  collaborator OTHER

• Queen's University, Belfast

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2023-08-31

Completion

2023-08-31

Countries

• United Kingdom

Study Locations