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Feasibility and acceptability of a multi-domain intervention to increase Mediterranean diet adherence and physical activity in older UK adults at risk of dementia: protocol for the MedEx-UK randomised controlled trial

Lookup NU author(s): Dr Oliver Shannon, Professor Bloss Stephan, Dr Stella Paddick, Dr Mario Siervo, Professor John Mathers

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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


Abstract

Introduction Dementia prevalence continues to increase, and effective interventions are needed to prevent, delay, or slow its progression. Higher adherence to the Mediterranean diet (MedDiet) and increased physical activity (PA) have been proposed as strategies to facilitate healthy brain ageing and reduce dementia risk. However, to date, there have been no dementia prevention trials in the UK focused on combined dietary and PA interventions. This study aims to: 1) assess feasibility and acceptability of a theory-underpinned digital and group-based intervention for dementia risk reduction in an ‘at risk’ UK cohort; 2) evaluate behaviour change responses to the intervention; and, 3) provide information on cognitive, neurological, vascular and physiological outcomes to inform the design of a follow-on, full-scale efficacy trial. Methods One hundred and eight participants aged 55-74 years with a QRISK2 score of ≥10% will be recruited to take part in this 24-week multi-site study. Participants will be randomised into three parallel arms: 1) Control; 2) MedDiet; and, 3) MedDiet+PA. The study will evaluate a personalised website, group session and food delivery intervention to increase MedDiet adherence and PA in older adults at risk of dementia. Diet and PA will be monitored prior to, during, and following the intervention. Feasibility, acceptability and hypothesised mediators will be assessed in addition to measures of cognitive function, brain structure/perfusion (MRI), vascular function, and metabolic markers (blood, urine and faecal) prior to, and following, the intervention. Discussion This trial will provide insights into the feasibility, acceptability and mechanism of effect of a multi-domain intervention focused on the MedDiet alone and PA for dementia risk reduction in an ‘at risk’ UK cohort. Ethics and dissemination The study has received NHS REC and HRA approval (18/NI/0191). Findings will be disseminated via conference presentations, public lectures, and peer-reviewed publications. Trial registration number: ClinicalTrials.gov NCT03673722


Publication metadata

Author(s): Shannon OM, Lee V, Bundy R, Gillings R, Jennings A, Stephan B, Hornberger M, Balanos GM, Paddick SM, Hanson S, Hardeman W, Holmes R, Garner N, Aldred S, Siervo M, Mathers JCM, Minihane AM

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2021

Volume: 11

Issue: 2

Online publication date: 05/02/2021

Acceptance date: 21/01/2021

Date deposited: 29/01/2021

ISSN (electronic): 2044-6055

Publisher: BMJ Group

URL: https://doi.org/10.1136/bmjopen-2020-042823

DOI: 10.1136/bmjopen-2020-042823


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