title: Effectiveness and cost-effectiveness of a very brief physical activity intervention delivered in NHS Health Checks (VBI Trial): study protocol for a randomised controlled trial.
abstract: Physical activity interventions that are targeted at individuals can be effective in encouraging people to be more physically active. However, most such interventions are too long or complex and not scalable to the general population. This trial will test the effectiveness and cost-effectiveness of a very brief physical activity intervention when delivered as part of preventative health checks in primary care (National Health Service (NHS) Health Check).
  
  
  
  The Very Brief Intervention (VBI) Trial is a two parallel-group, randomised, controlled trial with 1:1 individual allocation and follow-up at 3 months. A total of 1,140 participants will be recruited from 23 primary care practices in the east of England. Participants eligible for an NHS Health Check and who are considered suitable to take part by their doctor and able to provide written informed consent are eligible for the trial. Participants are randomly assigned at the beginning of the NHS Health Check to either 1) the control arm, in which they receive only the NHS Health Check, or 2) the intervention arm, in which they receive the NHS Health Check plus 'Step It Up' (a very brief intervention that can be delivered in 5 minutes by nurses and/or healthcare assistants at the end of the Health Check). 'Step It Up' includes (1) a face-to-face discussion, including feedback on current activity level, recommendations for physical activity, and information on how to use a pedometer, set step goals, and monitor progress; (2) written material supporting the discussion and tips and links to further resources to help increase physical activity; and (3) a pedometer to wear and a step chart for monitoring progress. The primary outcome is accelerometer counts per minute at 3-month follow-up. Secondary outcomes include the time spent in the different levels of physical activity, self-reported physical activity and economic measures. Trial recruitment is underway.
  
  
  
  The VBI trial will provide evidence on the effectiveness and cost-effectiveness of the Step It Up intervention delivered during NHS Health Checks and will inform policy decisions about introducing very brief interventions into routine primary care practice.
  
  
  
  ISRCTN Registry, ISRCTN72691150 . Registered on 17 July 2014.
authors.affiliation: Behavioural Science Group, Department of Public Health and Primary Care, Institute of Public Health, Forvie Site, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Mitchell
authors.affiliation: School of Health Sciences, University of East Anglia, Norwich Research Park, Norwich, NR4 7TJ, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Hardeman
authors.affiliation: Behavioural Science Group, Department of Public Health and Primary Care, Institute of Public Health, Forvie Site, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Pears
authors.affiliation: Imperial Clinical Trials Unit, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
authors.forename: Joana C
authors.initials: JC
authors.lastname: Vasconcelos
authors.affiliation: Imperial Clinical Trials Unit, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
authors.forename: A Toby
authors.initials: AT
authors.lastname: Prevost
authors.affiliation: Department of Public Health and Primary Care, Institute of Public Health, Forvie Site, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK.
authors.forename: Ed
authors.initials: E
authors.lastname: Wilson
authors.affiliation: Behavioural Science Group, Department of Public Health and Primary Care, Institute of Public Health, Forvie Site, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. srs34@medschl.cam.ac.uk.
authors.forename: Stephen
authors.initials: S
authors.lastname: Sutton
mesh_terms: D056044:Actigraphy / Q000191:economics / Q000295:instrumentation; D002318:Cardiovascular Diseases / Q000191:economics / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004739:England; D015444:Exercise; D000072936:Fitness Trackers / Q000191:economics; D015438:Health Behavior; D017048:Health Care Costs; D006304:Health Status; D006801:Humans; D010353:Patient Education as Topic / Q000191:economics; D011320:Primary Health Care / Q000191:economics* / Q000379:methods; D011322:Primary Prevention / Q000191:economics* / Q000379:methods; D012107:Research Design; D040242:Risk Reduction Behavior; D012648:Self Care / Q000191:economics*; D013222:State Medicine / Q000191:economics*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Accelerometry; Cost-effectiveness analysis; Pedometer; Physical activity; Primary health care; Randomised controlled trial; Very brief intervention