title: PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes.
  
  
  METHODS
  A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4% (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change.
  
  
  CONCLUSIONS
  This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention.
  
  
  BACKGROUND
  ISRCTN83465245 Trial registration date: 14/06/2012.
authors.affiliation: NIHR Leicester-Loughborough Diet, Lifestyle, and Physical Activity Biomedical Research Unit, Leicester, UK. ty20@le.ac.uk.|Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. ty20@le.ac.uk.|Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. ty20@le.ac.uk.
authors.forename: Tom
authors.initials: T
authors.lastname: Yates
authors.affiliation: Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Forvie Site, Box 113 Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. sjg49@medschl.cam.uk.
authors.forename: Simon
authors.initials: S
authors.lastname: Griffin
authors.affiliation: Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. dhm6@le.ac.uk.|Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. dhm6@le.ac.uk.
authors.forename: Danielle H
authors.initials: DH
authors.lastname: Bodicoat
authors.affiliation: MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. gwen.brierly@mrc-epid.cam.uk.
authors.forename: Gwen
authors.initials: G
authors.lastname: Brierly
authors.affiliation: Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. Helen.dallosso@uhl-tr.nhs.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Dallosso
authors.affiliation: NIHR Leicester-Loughborough Diet, Lifestyle, and Physical Activity Biomedical Research Unit, Leicester, UK. melanie.davies@uhl-tr.nhs.uk.|Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. melanie.davies@uhl-tr.nhs.uk.|Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. melanie.davies@uhl-tr.nhs.uk.
authors.forename: Melanie J
authors.initials: MJ
authors.lastname: Davies
authors.affiliation: Social Science Applied to Healthcare Improvement Research (SAPPHIRE) Group, Department of Health Sciences, University of Leicester, 22-28 Princess Road West, Leicester, LE1 6TP, UK. hce3@le.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Eborall
authors.affiliation: Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. ce95@le.ac.uk.|Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. ce95@le.ac.uk.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Edwardson
authors.affiliation: School of Health & Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. m.gillett@sheffield.ac.uk.
authors.forename: Mike
authors.initials: M
authors.lastname: Gillett
authors.affiliation: Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. lg48@le.ac.uk.|Department of Health Sciences, College of Medicine, Biological Sciences and Psychology, University of Leicester, 22-28 Princess Road West, Leicester, LE1 6TP, UK. lg48@le.ac.uk.
authors.forename: Laura
authors.initials: L
authors.lastname: Gray
authors.affiliation: Behavioural Science Group, Primary Care Unit, Institute of Public Health, Forvie Site, University of Cambridge, School of Clinical Medicine Box 113, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK. wh207@medschl.cam.ac.uk.
authors.forename: Wendy
authors.initials: W
authors.lastname: Hardeman
authors.affiliation: Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. sian.hill@uhl-tr.nhs.uk.
authors.forename: Sian
authors.initials: S
authors.lastname: Hill
authors.affiliation: UK CRC Centre for Diet and Activity Research (CEDAR), MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. km576@medschl.cam.ac.uk.
authors.forename: Katie
authors.initials: K
authors.lastname: Morton
authors.affiliation: Behavioural Science Group, Primary Care Unit, 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
authors.affiliation: Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. Jacqui.troughton@uhl-tr.nhs.uk.
authors.forename: Jacqui
authors.initials: J
authors.lastname: Troughton
authors.affiliation: Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, LE5 4PW, UK. kk22@le.ac.uk.|Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. kk22@le.ac.uk.
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Khunti
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000208:ethnology / Q000517:prevention & control*; D004739:England / Q000453:epidemiology; D015444:Exercise; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006293:Health Promotion; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D010174:Pamphlets; D010353:Patient Education as Topic; D015397:Program Evaluation; D065840:Protective Factors; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D040242:Risk Reduction Behavior; D057185:Sedentary Behavior / Q000208:ethnology; D013689:Telephone; D060145:Text Messaging; D013997:Time Factors; D044465:White People