Dataset Information

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.

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.

SUBMITTER: Shannon OM

PROVIDER: S-EPMC7925921 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Shannon Oliver M OM Lee Vivian V Bundy Rafe R Gillings Rachel R Jennings Amy A Stephan Blossom B Hornberger Michael M Balanos George G Paddick Stella Maria SM Hanson Sarah S Hardeman Wendy W Holmes Rebecca R Garner Nikki N Aldred Sarah S Siervo Mario M Mathers John C JC Minihane Anne Marie AM

BMJ open 20210205 2

<h4>Introduction</h4>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 an ...[more]

PMID: 33550254

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Project description:BackgroundDespite an urgent need for multi-domain lifestyle interventions to reduce dementia risk, there is a lack of interventions which are informed by theory- and evidence-based behaviour change strategies, and no interventions in this domain have investigated the feasibility or effectiveness of behaviour change maintenance. We tested the feasibility, acceptability and cognitive effects of a personalised theory-based 24-week intervention to improve Mediterranean diet (MD) adherence alone, or in combination with physical activity (PA), in older-adults at risk of dementia, defined using a cardiovascular risk score.MethodsParticipants (n = 104, 74% female, 57-76 years) were randomised to three parallel intervention arms: (1) control, (2) MD, or (3) MD + PA for 24 weeks and invited to an optional 24-week follow-up period with no active intervention. Behaviour change was supported using personalised targets, a web-based intervention, group sessions and food provision. The primary outcome was behaviour change (MD adherence and PA levels), and the secondary outcomes included feasibility and acceptability, cognitive function, cardiometabolic health (BMI and 24-h ambulatory blood pressure) and process measures.ResultsThe intervention was feasible and acceptable with the intended number of participants completing the study. Participant engagement with group sessions and food provision components was high. There was improved MD adherence in the two MD groups compared with control at 24 weeks (3.7 points on a 14-point scale (95% CI 2.9, 4.5) and 48 weeks (2.7 points (95% CI 1.6, 3.7)). The intervention did not significantly change objectively measured PA. Improvements in general cognition (0.22 (95% CI 0.05, 0.35), memory (0.31 (95% CI 0.10, 0.51) and select cardiovascular outcomes captured as underpinning physiological mechanisms were observed in the MD groups at 24 weeks.ConclusionsThe intervention was successful in initiating and maintaining dietary behaviour change for up to 12 months which resulted in cognitive benefits. It provides a framework for future complex behaviour change interventions with a range of health and well-being endpoints.Trial registrationClinicalTrials.gov NCT03673722.

Project description:Evidence for the cardioprotective effects of a Mediterranean-style (Med-style) diet is strong, however few Med-style dietary interventions have been developed for and tested among Hispanic Americans (HAs), especially younger HAs of reproductive age whose dietary habits may strongly influence dietary intake for all family members.We adapted a previously tested and evidence-informed lifestyle intervention to reduce CVD risk and evaluated its feasibility, acceptability, and effects on self-reported lifestyle behaviors in this study enrolling low-income HA women attending a Title X family planning clinic in eastern North Carolina. The 3-month long intervention, given to all participants, promoted a Med-style dietary pattern with a focus on increasing consumption of foods commonly consumed by HA that have high quality dietary fats (polyunsaturated and monounsaturated fats primarily from plant sources and fish) and carbohydrates (fruits, vegetables, and whole grains). The intervention also recommended increasing physical activity and was given during 2 face-to-face counseling sessions and 2 telephone counseling sessions. Major outcomes were engagement with study activities and intervention acceptability; lifestyle behavior change at 3-month follow-up is also reported.Baseline characteristics (n?=?36) were: mean age 33 years, 35 (97%) without health insurance, 32 (89%) born in Mexico, and mean BMI 30?kg/m2. Engagement was high among the 36 participants with 33 (92%) completing the intervention and follow-up measures. At follow-up, most participants thought the intervention was helpful (range: 85-100%) and acceptable (100% agreed 'I would recommend the program to others'). The mean dietary fat quality score improved by 0.5 units (95% CI: 0.0-1.1) and the mean fruit-vegetable servings/day improved by 0.7/day (95% CI: 0.1-1.3).Intervention engagement and acceptability were high and there was improvement in self-reported dietary behaviors. This type of Med-style dietary pattern intervention should be evaluated in randomized trials enrolling HAs at risk for CVD.

Project description:Background/objectivesDementia is not a single disease but an umbrella term that encompasses a range of symptoms, such as memory loss and cognitive impairments, which are severe enough to disrupt daily life. One of the most common forms of dementia is Alzheimer's Disease (AD), a complex neurodegenerative condition influenced by both genetic and environmental factors. Recent research has highlighted diet as a potential modifiable risk factor for AD. Decades of research have explored the role of dietary patterns, including the Mediterranean Diet (MD) and its components, in neuroprotection and cognitive health. Systematic review examines studies investigating the impact of the Mediterranean Diet, Mediterranean-like diets, the Nordic Diet (ND), dietary intake patterns, and specific components such as extra virgin olive oil and rapeseed oil on cognitive function, disease onset, and progression in AD and dementia.MethodsA comprehensive search of PubMed, the Directory of Open Access Journals, and the Social Science Research Network was conducted independently by two reviewers using predefined search terms. The search period included studies from 2006 to 2024. Eligible studies meeting the inclusion criteria were systematically reviewed, yielding 88 studies: 85 focused on the MD and its relationship to AD and dementia, while only 3 investigated the ND.ResultsThe findings suggest that adherence to the Mediterranean and Nordic diets is generally associated with improved cognitive function and delayed cognitive decline and that adherence to both these diets can improve cognitive function. Some studies identified that higher legume consumption decreased dementia incidence, while fruits and vegetables, carbohydrates, and eggs lowered dementia prevalence. Most studies demonstrated that high MD or ND adherence was associated with better cognitive function and a lower risk of poor cognition in comparison to individuals with lower MD or ND adherence. However, some studies reported no significant benefits of the MD on cognitive outcomes, while two studies indicated that higher red meat consumption was linked to better cognitive function.ConclusionDespite promising trends, the evidence remains varying across studies, underscoring the need for further research to establish definitive associations between diet and cognitive function. These findings highlight the essential role of dietary interventions in the prevention and management of dementia and AD, therefore offering critical insights into the underlying mechanisms by which the diet may impact brain health.

Project description:OBJECTIVE:The aim of this review was to evaluate the conceptual suitability, applicability and psychometric properties of scores used internationally to measure adherence to the Mediterranean diet (MD). DESIGN:This was a systematic review to identify original articles that examined some aspects of the conceptual suitability, applicability or psychometric properties of the MD adherence score. Electronic searches were carried out on the international databases MEDLINE, Scopus, Web of Science and EMBASE (from January 1980 to 31 December 2015). ELIGIBILITY CRITERIA FOR SELECTING STUDIES:The study included original articles that examined some aspects of the conceptual suitability, applicability or psychometric properties of the MD adherence score. The studies where MD adherence scores were administered but did not bring forward any evidence about their performance related to conceptual suitability, applicability or psychometric properties were excluded. DATA EXTRACTION:Information relating to the scales was extracted in accordance with the quality criteria defined by the Scientific Advisory Committee of the Medical Outcomes Trust for measurement of health results and the quality criteria recommended by Terwee: (1) conceptual, (2) applicability and (3) psychometric properties. Three authors independently extracted information from eligible studies. RESULTS:Twenty-seven studies were identified as meeting the inclusion criteria, yielding 28 MD adherence scores. The results showed that evidence is scarce and that very few scores fulfilled the applicability parameters and psychometric quality. The scores developed by Panagiotakos et al, Buckland et al and Sotos-Prieto et al showed the highest levels of evidence. CONCLUSIONS:Scores measuring adherence to MD are useful tools for identifying the dietary patterns of a given population. However, further information is required regarding existing scores. In addition, new instruments with greater conceptual and methodological rigour should be developed and evaluated for their psychometric properties.

Dataset Information

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.

Introduction

Methods

Discussion

Ethics and dissemination

Trial registration details

Publications

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.

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