title: Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial.
abstract: Prevention of falls and promotion of physical activity are essential for maximising well-being in older age. However, there is evidence that promoting physical activity among older people without providing fall prevention advice may increase fall rates. This trial aims to establish the impact of a physical activity and fall prevention programme compared with a healthy eating programme on physical activity and falls among people aged 60+ years.
  
  
  
  This cluster randomised controlled trial will involve 60 groups of community-dwelling people aged 60+ years. Participating groups will be randomised to: (1) a physical activity and fall prevention intervention (30 groups), involving written information, fall risk assessment and prevention advice, a pedometer-based physical activity tracker and telephone-based health coaching; or (2) a healthy eating intervention (30 groups) involving written information and telephone-based dietary coaching. Primary outcomes will be objectively measured physical activity at 12 months post-randomisation and self-reported falls throughout the 12-month trial period. Secondary outcomes include: the proportion of fallers, the proportion of people meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and health and community service use. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will be preplanned, conducted while masked to group allocation, will take into account cluster randomisation, and will use an intention-to-treat approach.
  
  
  
  Protocol has been approved by the Human Research Ethics Committee at The University of Sydney, Australia (number 2015/517). Results will be disseminated via peer-reviewed journal articles, international conference presentations and participants' newsletters.
  
  
  
  ACTRN12615001190594.
authors.affiliation: The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Anne
authors.initials: A
authors.lastname: Tiedemann
authors.affiliation: Sydney School of Public Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Chris
authors.initials: C
authors.lastname: Rissel
authors.affiliation: Sydney School of Public Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Howard
authors.affiliation: Sydney School of Public Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Allison
authors.initials: A
authors.lastname: Tong
authors.affiliation: School of Science and Health, Western Sydney University, Sydney, New South Wales, Australia.
authors.forename: Dafna
authors.initials: D
authors.lastname: Merom
authors.affiliation: Faculty of Arts and Business, University of the Sunshine Coast, Sippy Downs, Queensland, Australia.
authors.forename: Stuart
authors.initials: S
authors.lastname: Smith
authors.affiliation: School of Biomedical Sciences, Charles Sturt University, Orange, New South Wales, Australia.
authors.forename: James
authors.initials: J
authors.lastname: Wickham
authors.affiliation: Sydney School of Public Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Adrian
authors.initials: A
authors.lastname: Bauman
authors.affiliation: Neuroscience Research Australia, University of New South Wales, Randwick, New South Wales, Australia.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Lord
authors.affiliation: Northern Clinical School, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia Department of Aged Care, Royal North Shore Hospital, Sydney, New South Wales, Australia.
authors.forename: Constance
authors.initials: C
authors.lastname: Vogler
authors.affiliation: The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Richard I
authors.initials: RI
authors.lastname: Lindley
authors.affiliation: Sydney School of Public Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Judy M
authors.initials: JM
authors.lastname: Simpson
authors.affiliation: Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Margaret
authors.initials: M
authors.lastname: Allman-Farinelli
authors.affiliation: The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Catherine
authors.initials: C
authors.lastname: Sherrington
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D016000:Cluster Analysis; D004032:Diet; D000072001:Diet, Healthy; D015444:Exercise; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006299:Health Services for the Aged / Q000458:organization & administration; D006801:Humans; D008297:Male; D000071252:Mentoring; D008875:Middle Aged; D011322:Primary Prevention / Q000379:methods*; D016312:Treatment Refusal
keywords: GERIATRIC MEDICINE; PREVENTIVE MEDICINE; PUBLIC HEALTH