Mediterranean Diet, Exercise and Dementia Risk in UK Adults
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      In cohort studies, a Mediterranean Dietary Pattern (MDP) has been consistently associated
      with reduced dementia incidence. The efficacy of a MDP to prevent dementia has never been
      directly demonstrated by RCTs, with existing research limited to cognition as a secondary
      outcome. Furthermore, despite their likely additive effects, the combined impact of Physical
      Activity (PA) and a MDP on dementia risk is unknown.

      MedEx-UK is a RCT that will evaluate the feasibility of a multi-domain intervention to
      increase Mediterranean Dietary Pattern (MDP) adherence and physical activity (PA) in a group
      of older UK adults who are at above average risk of dementia.
    

Detailed description: 
      In MedEx-UK the investigators propose to conduct a feasibility study in three UK centres
      (Norwich, Birmingham, Newcastle) which collectively will recruit 108 UK older adults (55-74y)
      who are at above average risk of dementia, but pre-clinical. Primary outcome is to evaluate
      the feasibility of a multi-domain intervention to increase MDP adherence and PA over a 24
      week period, and to demonstrate the possibility of achieving meaningful behavioural change in
      a UK population. Secondary outcomes will be to measure the sensitivity of various cognitive
      assessments and measure the variability of our primary and secondary outcome measures in this
      population at baseline and in response to intervention.

      There are three intervention arms to the study, and participants will be randomised with
      minimisation for gender and Mediterranean Diet Adherence Screener score (MEDAS; a validated
      questionnaire)

        1. MDP:

           Participants will be asked to alter their consumption of foods consistent with a
           Mediterranean Diet. Examples include increased intake of fruits and vegetables, nuts,
           olive oil as the main culinary fat, moderate wine consumption (if they already consume
           alcohol), preferring white meat over red, and a reduction in commercial sweet and
           pastries, and sugar-sweetened drinks.

        2. MDP plus PA:

           As well as the dietary intervention as in 1., participants will be asked to increase
           their PA using a mixture of structured (e.g. dancing, Zumba classes, swimming etc.) and
           non-structured (walking up stairs, gardening etc.) activities.

        3. Control:

      Participants will be given generic healthy eating advice based on the NHS 'Eatwell' plate and
      UK British Heart Foundation (BHF) guidelines.

      The overall purpose of this study is to inform the feasibility and design of a future
      large-scale UK dementia risk reduction RCT, to observe whether a multi-domain intervention
      over 2 to 5 years promoting MDP adherence and increased PA can reduce cognitive decline and
      brain atrophy in adults at above average risk of dementia.
    

Intervention name(s): Foods consistent with a MDP; Physical Activity; Control
Intervention type(s): Other; Other; Other
Intervention description(s): We aim to increase MDP by 3 points, according to a 14-point MEDAS score; We aim to increase PA to 150 minutes moderate activity per week.; Participants will be given generic healthy eating advice based
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mediterranean Diet; Physical Activity; Dementia; Alzheimer Disease; Cognition