title: Efficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial).
abstract: BACKGROUND
  Physical inactivity is fourth in the list of risk factors for global mortality. General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier. Although referral to an exercise specialist is an alternative, in Australia, these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness. Accordingly, this trial aims to determine the efficacy of GP referral of insufficiently active patients (regardless of their chronic disease status) for physical activity counseling (either face-to-face or predominately via telephone) by exercise specialists, based on patients' objectively assessed physical activity levels, compared with usual care. If the trial is efficacious, the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed.
  
  
  METHODS
  This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales, Australia. Insufficiently active (less than 7000 steps/day) consenting adult patients will be randomly assigned to: 1) five face-to-face counseling sessions, 2) one face-to-face counseling session followed by four telephone calls, or 3) a generic mailed physical activity brochure (usual care). The interventions will operationalize social cognitive theory via a behavior change counseling framework. Participants will complete a survey and seven days of pedometry at baseline, and at three and 12 months post-randomization. The primary analyses will be based on intention-to-treat principles and will compare: (i) mean change in average daily step counts between baseline and 12 months for the combined intervention group (Group 1: face-to-face, and Group 2: telephone) and usual care (Group 3); (ii) step counts at 3 months post-randomization. Secondary outcomes include: self-reported physical activity, sedentary behavior, quality of life, and depression.
  
  
  CONCLUSIONS
  If referral of primary care patients to exercise specialists increases physical activity, this process offers the prospect of systematically and sustainably reaching a large proportion of insufficiently active adults. If shown to be efficacious this trial provides evidence to expand public funding beyond those with a chronic disease and for delivery via telephone as well as face-to-face consultations.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12611000884909 .
authors.affiliation: School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. Erica.James@newcastle.edu.au.|Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia. Erica.James@newcastle.edu.au.|Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia. Erica.James@newcastle.edu.au.|Hunter Medical Research Institute, University of Newcastle, Callaghan, NSW, Australia. Erica.James@newcastle.edu.au.
authors.forename: Erica L
authors.initials: EL
authors.lastname: James
authors.affiliation: School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. Benjamin.Ewald@newcastle.edu.au.|Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia. Benjamin.Ewald@newcastle.edu.au.|Hunter Medical Research Institute, University of Newcastle, Callaghan, NSW, Australia. Benjamin.Ewald@newcastle.edu.au.
authors.forename: Ben
authors.initials: B
authors.lastname: Ewald
authors.affiliation: School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. Natalie.Johnson@newcastle.edu.au.|Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia. Natalie.Johnson@newcastle.edu.au.|Hunter Medical Research Institute, University of Newcastle, Callaghan, NSW, Australia. Natalie.Johnson@newcastle.edu.au.
authors.forename: Natalie
authors.initials: N
authors.lastname: Johnson
authors.affiliation: School of Human Movement Studies, University of Queensland, St Lucia, QLD, Australia. wbrown@hms.uq.edu.au.
authors.forename: Wendy
authors.initials: W
authors.lastname: Brown
authors.affiliation: School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. Fiona.Stacey@newcastle.edu.au.|Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia. Fiona.Stacey@newcastle.edu.au.|Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia. Fiona.Stacey@newcastle.edu.au.|Hunter Medical Research Institute, University of Newcastle, Callaghan, NSW, Australia. Fiona.Stacey@newcastle.edu.au.
authors.forename: Fiona G
authors.initials: FG
authors.lastname: Stacey
authors.affiliation: School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. Patrick.Mcelduff@newcastle.edu.au.
authors.forename: Patrick
authors.initials: P
authors.lastname: Mcelduff
authors.affiliation: School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. Angela.Booth@newcastle.edu.au.
authors.forename: Angela
authors.initials: A
authors.lastname: Booth
authors.affiliation: Inner West Sydney Medicare Local, Ashfield, NSW, Australia. FYang@iwsml.com.au.
authors.forename: Fan
authors.initials: F
authors.lastname: Yang
authors.affiliation: General Practice Research, School of Medicine, Sydney, The University of Notre Dame, Darlinghurst, NSW, Australia. charlotte.hespe@nd.edu.au.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Hespe
authors.affiliation: Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia. Ronald.Plotnikoff@newcastle.edu.au.|Hunter Medical Research Institute, University of Newcastle, Callaghan, NSW, Australia. Ronald.Plotnikoff@newcastle.edu.au.
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Plotnikoff
mesh_terms: D000328:Adult; D001315:Australia; D003376:Counseling / Q000379:methods*; D003863:Depression; D015444:Exercise; D058006:General Practice / Q000379:methods*; D006801:Humans; D009043:Motor Activity; D009517:New South Wales; D011788:Quality of Life; D012017:Referral and Consultation; D057185:Sedentary Behavior; D013689:Telephone