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Lookup NU author(s): Dr Oliver Shannon, Professor Bloss Stephan, Dr Stella Paddick, Dr Mario Siervo, Professor John Mathers
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
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
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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