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

Oliver M Shannon; Vivian Lee; Rafe Bundy; Rachel Gillings; Amy Jennings; Blossom Stephan; Michael Hornberger; George Balanos; Stella Maria Paddick; Sarah Hanson; Wendy Hardeman; Rebecca Holmes; Nikki Garner; Sarah Aldred; Mario Siervo; John C Mathers; Anne Marie Minihane

doi:10.1136/bmjopen-2020-042823

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

BMJ Open. 2021 Feb 5;11(2):e042823. doi: 10.1136/bmjopen-2020-042823.

Authors

Oliver M Shannon¹, Vivian Lee², Rafe Bundy³, Rachel Gillings³, Amy Jennings³, Blossom Stephan⁴, Michael Hornberger⁵, George Balanos², Stella Maria Paddick^{6

7}, Sarah Hanson⁸, Wendy Hardeman⁹, Rebecca Holmes³, Nikki Garner^{3

10}, Sarah Aldred^{2

11}, Mario Siervo¹², John C Mathers¹, Anne Marie Minihane¹³

Affiliations

¹ Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
² School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.
³ Department of Nutrition and Preventive Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.
⁴ Institute of Mental Health, Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, Nottinghamshire, UK.
⁵ Norwich Medical School, University of East Anglia, Norwich, UK.
⁶ Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
⁷ Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Newcastle, UK.
⁸ School of Health Sciences, Norwich Medical School, University of East Anglia, Norwich, UK.
⁹ Behavioural and Implementation Science Group, School of Health Sciences, University of East Anglia, Norwich, UK.
¹⁰ Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.
¹¹ Centre for Human Brain Health, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.
¹² School of Life Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK.
¹³ Department of Nutrition and Preventive Medicine, Norwich Medical School, University of East Anglia, Norwich, UK a.minihane@uea.ac.uk.

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 focussed 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 to 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 focussed 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 details: ClinicalTrials.gov NCT03673722.

Keywords: dementia; nutrition & dietetics; public health.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Dementia* / prevention & control
Diet, Mediterranean*
Exercise
Feasibility Studies
Humans
Middle Aged
Randomized Controlled Trials as Topic
United Kingdom

Associated data

ClinicalTrials.gov/NCT03673722

Grants and funding

MR/P020941/1/MRC_/Medical Research Council/United Kingdom