title: The Agewell trial: a pilot randomised controlled trial of a behaviour change intervention to promote healthy ageing and reduce risk of dementia in later life.
abstract: BACKGROUND
  Lifestyle factors represent prime targets for behaviour change interventions to promote healthy ageing and reduce dementia risk. We evaluated a goal-setting intervention aimed at promoting increased cognitive and physical activity and improving mental and physical fitness, diet and health.
  
  
  METHODS
  This was a pilot randomised controlled trial designed to guide planning for a larger-scale investigation, provide preliminary evidence regarding efficacy, and explore feasibility and acceptability. Primary outcomes were engagement in physical and cognitive activity. Participants aged over 50 living independently in the community were recruited through a community Agewell Centre. Following baseline assessment participants were randomly allocated to one of three conditions: control (IC) had an interview in which information about activities and health was discussed; goal-setting (GS n = 24) had an interview in which they set behaviour change goals relating to physical, cognitive and social activity, health and nutrition; and goal-setting with mentoring (GM, n = 24) had the goal-setting interview followed by bi-monthly telephone mentoring. Participants and researchers were blinded to group assignment. Participants were reassessed after 12 months.
  
  
  RESULTS
  Seventy-five participants were randomised (IC n = 27, GS n = 24, GM n = 24). At 12-month follow-up, the two goal-setting groups, taken together (GS n = 21, GM n = 22), increased their level of physical (effect size 0.37) and cognitive (effect size 0.15) activity relative to controls (IC n = 27). In secondary outcomes, the two goal-setting groups taken together achieved additional benefits compared to control (effect sizes ≥ 0.2) in memory, executive function, cholesterol level, aerobic capacity, flexibility, balance, grip strength, and agility. Adding follow-up mentoring produced further benefits compared to goal-setting alone (effect sizes ≥ 0.2) in physical activity, body composition, global cognition and memory, but not in other domains. Implementation of the recruitment procedure, assessment and intervention was found to be feasible and the approach taken was acceptable to participants, with no adverse effects.
  
  
  CONCLUSIONS
  A brief, low-cost goal-setting intervention is feasible and acceptable, and has the potential to achieve increased activity engagement.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN30080637.
authors.affiliation: Research in Ageing and Cognitive Health, School of Psychology, Bangor University, Bangor, Gwynedd, LL57 2AS, UK. l.clare@bangor.ac.uk.
authors.forename: Linda
authors.initials: L
authors.lastname: Clare
authors.affiliation: Research in Ageing and Cognitive Health, School of Psychology, Bangor University, Bangor, Gwynedd, LL57 2AS, UK. s.nelis@bangor.ac.uk.
authors.forename: Sharon M
authors.initials: SM
authors.lastname: Nelis
authors.affiliation: Wales Institute of Social & Economic Research, Data & Methods, Cardiff University, Cardiff, UK. jonesir4@cardiff.ac.uk.
authors.forename: Ian R
authors.initials: IR
authors.lastname: Jones
authors.affiliation: School of Medical Sciences, Bangor University, Bangor, UK. j.v.hindle@bangor.ac.uk.
authors.forename: John V
authors.initials: JV
authors.lastname: Hindle
authors.affiliation: School of Medicine, University of New South Wales, New South Wales, Australia. j.thom@unsw.edu.au.
authors.forename: Jeanette M
authors.initials: JM
authors.lastname: Thom
authors.affiliation: Research in Ageing and Cognitive Health, School of Psychology, Bangor University, Bangor, Gwynedd, LL57 2AS, UK. j.a.nixon@bangor.ac.uk.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Nixon
authors.affiliation: School of Sports, Health and Exercise Sciences, Bangor University, Bangor, UK. j.cooney@bangor.ac.uk.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Cooney
authors.affiliation: Centre for Health Economics and Medicines Evaluation, IMSCaR, Bangor University, Bangor, UK. c.l.jones@bangor.ac.uk.
authors.forename: Carys L
authors.initials: CL
authors.lastname: Jones
authors.affiliation: Centre for Health Economics and Medicines Evaluation, IMSCaR, Bangor University, Bangor, UK. r.t.edwards@bangor.ac.uk.
authors.forename: Rhiannon
authors.initials: R
authors.lastname: Tudor Edwards
authors.affiliation: North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK. c.j.whitaker@bangor.ac.uk.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Whitaker
mesh_terms: D000368:Aged; D000375:Aging / Q000523:psychology*; D001521:Behavior Therapy; D003071:Cognition; D003704:Dementia / Q000517:prevention & control* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D010342:Patient Acceptance of Health Care; D010865:Pilot Projects