Border Region Area Lifestyle Intervention Study for Healthy Neurocognitive Ageing Diabetes

NCT05304975 | Completed

• 1 other identifier: 09069PP
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Evaluation of recruitment strategies, retention, attrition rates and reasons for withdrawal for study participants in both intervention and control groups

  This is a feasibility study. we need to collect data on recruitment strategies. We will maintain a record of how many people were contacted, how many consented, the numbers dropping out and the reasons for withdrawal

  at 6 months. T

• Determination of fidelity of implementation, feasibility and acceptability of the intervention

  we will record subject compliance with the study intervention and the feasibility of that intervention. by a questionnaire

  at 6 months.

• Generation of variability data on the primary outcome measure (cognition) from baseline to 6 months on which to base a formal power calculation for a large-scale trial

  Cognition will be assessed using CATCH COG

  6 months.

Study Arms (2)

intervention

ACTIVE COMPARATOR

Participants will be provided with written dietary education, meal plan, recipe ideas, tips and suggestions at their baseline and review study visits. The exercise intervention will be delivered remotely. Participants will undergo a physical performance assessment at baseline and receive a home exercise resource that has been designed for older adults. Cognitive stimulation will be delivered using Brain HQ®, a computer based cognitive training platform, which utilises visuospatial and auditory games to enhance attention, mental processing speed, learning, memory, and low mood. 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. The 4-month active intervention will be followed by a 2-month self-directed consolidation phase and all participants will be left to their own initiative for a further 3 months

Behavioral: diet; Behavioral: cognitive stimulation; Behavioral: physical activity; Other: risk factor management

control

OTHER

this will be routine management of the diabetes condition as per current recommended practice

Other: risk factor management

Interventions

diet BEHAVIORAL

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

intervention

cognitive stimulation BEHAVIORAL

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

intervention

physical activity BEHAVIORAL

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.

intervention

risk factor management OTHER

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

control; intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Type 2 Diabetes mellitus
• aged ≥50 years
• within five years of diagnosis
• access to a computer, tablet or smartphone -

You may not qualify if:

• conditions affecting safe engagement in the intervention (especially the exercise component)
• insulin therapy
• malignant diseases
• major depression within 6 months
• dementia/substantial cognitive decline
• Mini Mental State Examination \<20
• symptomatic cardiovascular disease
• revascularization within 1 year
• severe loss of vision, hearing, or communicative ability
• conditions preventing cooperation as judged by the study physician
• coincident participation in any intervention trial. -

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Western Health and Social Care Trust: collaborator

Study Sites (1)

South West Acute Hospital

Enniskillen, Co Fermanagh, United Kingdom

Location

Related Publications (1)

• McEvoy CT, McCarthy G, Townsend RF, Dolan C, Regan-Moriarty J, Cardwell C, McGuinness B, Kennelly SP, Kelly J, McHugh C, Kee F, Bartlett J, Bradshaw C, Reynolds O, Mortland V, O'Neill C, McLoughlin I, McCaffrey N, Heffernan M, Nolan C, Passmore PA. BRAIN-Diabetes: a randomised trial to test the feasibility of an adapted FINGER multidomain intervention in adults with type 2 diabetes living in rural border regions of Ireland. Eur J Ageing. 2025 Jun 24;22(1):30. doi: 10.1007/s10433-025-00862-0.

  PMID: 40550886 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: March 31, 2022
• Study Start: November 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)