title: Reducing dementia risk by targeting modifiable risk factors in mid-life: study protocol for the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) randomised controlled feasibility trial.
abstract: BACKGROUND
  Dementia prevalence is increasing as populations live longer, with no cure and the costs of caring exceeding many other conditions. There is increasing evidence for modifiable risk factors which, if addressed in mid-life, can reduce the risk of developing dementia in later life. These include physical inactivity, low cognitive activity, mid-life obesity, high blood pressure, and high cholesterol. This study aims to assess the acceptability and feasibility and impact of giving those in mid-life, aged between 40 and 60 years, an individualised dementia risk modification score and profile and access to personalised on-line health information and goal setting in order to support the behaviour change required to reduce such dementia risk. A secondary aim is to understand participants' and practitioners' views of dementia prevention and explore the acceptability and integration of the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) intervention into daily life and routine practice.
  
  
  METHODS
  In-MINDD is a multi-centre, primary care-based, single-blinded randomised controlled feasibility trial currently being conducted in four European countries (France, Ireland, the Netherlands and the UK). Participants are being recruited from participating general practices. Inclusion criteria will include age between 40 and 60 years; at least one modifiable risk factor for dementia risk (including diabetes, hypertension, obesity, renal dysfunction, current smoker, raised cholesterol, coronary heart disease, current or previous history of depression, self-reported sedentary lifestyle, and self-reported low cognitive activity) access to the Internet. Primary outcome measure will be a change in dementia risk modification score over the timescale of the trial (6 months). A qualitative process evaluation will interview a sample of participants and practitioners about their views on the acceptability and feasibility of the trial and the links between modifiable risk factors and dementia prevention. This work will be underpinned by Normalisation Process Theory.
  
  
  CONCLUSIONS
  This study will explore the feasibility and acceptability of a risk profiler and on-line support environment to help individuals in mid-life assess their risk of developing dementia in later life and to take steps to alleviate that risk by tackling health-related behaviour change. Testing the intervention in a robust and theoretically informed manner will inform the development of a future, full-scale randomised controlled trial.
  
  
  BACKGROUND
  ISRCTN Registry: ISRCTN 98553005 (DOI: 10.1186/ISRCTN98553005).
authors.affiliation: General Practice and Primary Care, Institute of Health & Wellbeing, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX Scotland UK.
authors.forename: Catherine A
authors.initials: CA
authors.lastname: O'Donnell
authors.affiliation: General Practice and Primary Care, Institute of Health & Wellbeing, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX Scotland UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Browne
authors.affiliation: School of Nursing and Human Sciences, Dublin City University, Dublin, Ireland.
authors.forename: Maria
authors.initials: M
authors.lastname: Pierce
authors.affiliation: Robertson Centre for Biostatistics, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.
authors.forename: Alex
authors.initials: A
authors.lastname: McConnachie
authors.affiliation: School for Mental Health and Neuroscience, Alzheimer Centrum Limburg, Maastricht University, Maastricht, The Netherlands.
authors.forename: Kay
authors.initials: K
authors.lastname: Deckers
authors.affiliation: School for Mental Health and Neuroscience, Alzheimer Centrum Limburg, Maastricht University, Maastricht, The Netherlands.
authors.forename: Martin P J
authors.initials: MP
authors.lastname: van Boxtel
authors.affiliation: CoBTeK COgnition Behaviour Technology, Université de Nice Sophia Antipolis, Nice, France.
authors.forename: Valeria
authors.initials: V
authors.lastname: Manera
authors.affiliation: School for Mental Health and Neuroscience, Alzheimer Centrum Limburg, Maastricht University, Maastricht, The Netherlands.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Köhler
authors.affiliation: School of Nursing and Human Sciences, Dublin City University, Dublin, Ireland.
authors.forename: Muriel
authors.initials: M
authors.lastname: Redmond
authors.affiliation: School for Mental Health and Neuroscience, Alzheimer Centrum Limburg, Maastricht University, Maastricht, The Netherlands.
authors.forename: Frans R J
authors.initials: FR
authors.lastname: Verhey
authors.affiliation: School for Mental Health and Neuroscience, Alzheimer Centrum Limburg, Maastricht University, Maastricht, The Netherlands.
authors.forename: Marjan
authors.initials: M
authors.lastname: van den Akker
authors.affiliation: School of Nursing and Human Sciences, Dublin City University, Dublin, Ireland.
authors.forename: Kevin
authors.initials: K
authors.lastname: Power
authors.affiliation: School of Nursing and Human Sciences, Dublin City University, Dublin, Ireland.
authors.forename: Kate
authors.initials: K
authors.lastname: Irving
keywords: Dementia; Internet; Modifiable risk factors; Primary care; Primary prevention