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  • Protocol for a pragmatic randomised controlled trial of Body Brain Life—General Practice and a Lifestyle Modification Programme to decrease dementia risk exposure in a primary care setting

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Protocol
Protocol for a pragmatic randomised controlled trial of Body Brain Life—General Practice and a Lifestyle Modification Programme to decrease dementia risk exposure in a primary care setting
  1. Sarang Kim1,
  2. Mitchell McMaster1,
  3. Susan Torres2,
  4. Kay L Cox3,
  5. Nicola Lautenschlager4,
  6. George W Rebok5,
  7. Dimity Pond6,
  8. Catherine D’Este7,
  9. Ian McRae1,
  10. Nicolas Cherbuin1,
  11. Kaarin J Anstey1,8,9
  1. 1 Centre for Research on Ageing, Health and Wellbeing, Australian National University, Canberra, Australian Capital Territory, Australia
  2. 2 School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia
  3. 3 Medical School, University of Western Australia, Crawley, Western Australia, Australia
  4. 4 Academic Unit for Psychiatry of Old Age, University of Melbourne, Melbourne, Victoria, Australia
  5. 5 Johns Hopkins Center on Aging and Health, Johns Hopkins University, Baltimore, Maryland, USA
  6. 6 School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia
  7. 7 National Centre for Epidemiology and Population Health (NCEPH), Australian National University, Canberra, Australian Capital Territory, Australia
  8. 8 School of Psychology, University of New South Wales, Sydney, New South Wales, Australia
  9. 9 Neuroscience Research Australia, Sydney, New South Wales, Australia
  1. Correspondence to Dr Sarang Kim; sarang.kim{at}anu.edu.au

Abstract

Introduction It has been estimated that a 10%–25% reduction in seven key risk factors could potentially prevent 1.1–3.0 million Alzheimer’s disease cases globally. In addition, as dementia is preceded by more subtle cognitive deficits which have substantial social and economic impact, effective preventative interventions would likely have more extensive benefits. The current study evaluates in primary care a multidomain risk-reduction intervention targeting adults with high risk of developing dementia.

Methods and analysis A randomised controlled trial (RCT) is being conducted to evaluate three intervention programmes using a pragmatic approach suitable to the clinic: (1) a 12-week online and face-to-face dementia risk-reduction intervention (Body Brain Life—General Practice (BBL-GP)); (2) a 6-week face-to-face group lifestyle modification programme (LMP); and (3) a 12-week email-only programme providing general health information. We aim to recruit 240 participants, aged 18 and over, to undergo a comprehensive cognitive and physical assessment at baseline and follow-ups (postintervention, 18, 36 and 62 weeks). The primary outcome is dementia risk measured with the modified version of the Australian National University—Alzheimer’s Disease Risk Index Short Form. Secondary outcomes are cognitive function measured with Trails A and B, and the Digit Symbol Modalities Test; physical activity with moderate-vigorous physical activity and the International Physical Activity Questionnaire; depression with the Centre for Epidemiological Studies Depression; cost evaluation with the 12-item Short Form Health Survey, Framingham Coronary Heart Disease Risk Score and Australian Type 2 Diabetes Risk Assessment Tool; diet quality with the Australian Recommended Food Score; and sleep quality with the Pittsburgh Sleep Quality Index.

Ethics and dissemination This RCT is a novel pragmatic intervention applied in a primary care setting to reduce the dementia risk exposure in adults at high risk. If successful, BBL-GP and LMP will provide a versatile, evidence-based package that can be easily and quickly rolled out to other primary care settings and which can be scaled up at relatively low cost compared with other strategies involving intensive interventions.

Trial registration number ACTRN12616000868482

  • rct
  • dementia
  • lifestyle change
  • online
  • australia
  • general practice

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-019329

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    Footnotes

    • Contributors KJA conceived the study and built relationship with NC. KJA, NC and SK developed the overall design of the intervention. NL and KLC designed the implementation of the PA-related intervention. CD and KJA designed the statistical analysis plan for the protocol. DP and GWR contributed knowledge of primary care setting and advised on implementing the intervention in a GP clinic. ST designed the implementation of the dietary intervention. NC and SK managed the implementation of the online component in the dedicated web portal. SK, MM, ST, KLC, NL, GWR, DP, IM, NC and KJA wrote the study protocol and critically reviewed the manuscript.

    • Funding This work was supported by National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Cognitive Health and the development of original BBL modules was funded by the NHMRC Dementia Collaborative Research Centres. KJA is funded by NHMRC Fellowship APP1102694.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval The Human Research Ethics Committee at the Australian National University.

    • Provenance and peer review Not commissioned; externally peer reviewed.