title: A 12-week multidomain intervention versus active control to reduce risk of Alzheimer's disease: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Disappointing results from clinical trials of disease-modifying interventions for Alzheimer's dementia (AD), along with reliable identification of modifiable risk factors in mid life from epidemiological studies, have contributed to calls to invest in risk-reduction interventions. It is also well known that AD-related pathological processes begin more than a decade before the development of clinical signs. These observations suggest that lifestyle interventions might be most effective when targeting non-symptomatic adults at risk of AD. To date, however, the few dementia risk-reduction programs available have targeted individual risk factors and/or were restricted to clinical settings. The current study describes the development of an evidence-based, theoretically-driven multidomain intervention to reduce AD risk in adults at risk.
  
  
  METHODS
  The design of Body Brain Life (BBL) is a randomized controlled trial (RCT) to evaluate a 12-week online AD risk-reduction intervention. Eligible participants with several modifiable risk factors on the Australian National University (ANU) AD Risk Index (ANU-ADRI) are randomly allocated to an online only group, an online and face-to-face group, or an active control group. We aim to recruit 180 participants, to undergo a comprehensive cognitive and physical assessment at baseline, post-intervention, and 6-month follow-up assessment. The intervention comprises seven online modules (dementia literacy, risk factor education, engagement in physical, social, and cognitive lifestyles, nutrition, and health monitoring) designed using contemporary models of health behavior change.
  
  
  CONCLUSIONS
  The BBL program is a novel online intervention to reduce the risk of AD in middle-aged adults at risk. The trial is currently under way. It is hypothesized that participants in the intervention arms will make lifestyle changes in several domains, and that this will lead to a reduction in their AD risk profile. We also expect to show that health behavior change is underpinned by changes in psychological determinants of behavior. If successful, the findings will contribute to the development of further dementia risk reduction interventions, and thus contribute to the urgent need to lower dementia risk factors in the population to alter future projections of disease prevalence. Longer follow-up of BBL participants and replications using large samples are required to examine whether reduction in AD risk factors will be associated with reduced prevalence.
  
  
  BACKGROUND
  Reg. no. ACTRN12612000147886.
authors: Centre for Research on Ageing Health and Wellbeing, The Australian National University, Canberra, Australia. Kaarin.anstey@anu.edu.au
authors: Kaarin J
authors: KJ
authors: Anstey
authors: Alex
authors: A
authors: Bahar-Fuchs
authors: Pushpani
authors: P
authors: Herath
authors: George W
authors: GW
authors: Rebok
authors: Nicolas
authors: N
authors: Cherbuin
mesh_terms: D000544:Alzheimer Disease / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D020958:Australian Capital Territory / Q000453:epidemiology; D002985:Clinical Protocols; D006126:Group Processes; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D057220:Health Literacy; D006801:Humans; D020407:Internet; D008019:Life Style; D008603:Mental Health; D008875:Middle Aged; D009517:New South Wales / Q000453:epidemiology; D009752:Nutritional Status; D010353:Patient Education as Topic; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D040242:Risk Reduction Behavior; D016037:Single-Blind Method; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D016896:Treatment Outcome