title: A community based primary prevention programme for type 2 diabetes integrating identification and lifestyle intervention for prevention: the Let's Prevent Diabetes cluster randomised controlled trial.
abstract: OBJECTIVE
  Prevention of type 2 diabetes (T2DM) is a priority in healthcare, but there is a lack of evidence investigating how to effectively translate prevention research into a UK primary care setting. We assessed whether a structured education programme targeting lifestyle and behaviour change was effective at preventing progression to T2DM in people with pre-diabetes.
  
  
  METHODS
  Forty-four general practices were randomised to receive either standard care or a 6hour group structured education programme with an annual refresher course, and regular phone contact. Participants were followed up for 3years. The primary outcome was progression to T2DM.
  
  
  RESULTS
  Eight hundred and eighty participants were included (36% female, mean age 64years, 16% ethnic minority group); 131 participants developed T2DM. There was a non-significant 26% reduced risk of developing T2DM in the intervention arm compared to standard care (HR 0.74, 95% CI 0.48, 1.14, p=0.18). The reduction in T2DM risk when excluding those who did not attend the initial education session was also non-significant (HR 0.65, 0.41, 1.03, p=0.07). There were statistically significant improvements in HbA1c (-0.06, -0.11, -0.01), LDL cholesterol (-0.08, -0.15, -0.01), sedentary time (-26.29, -45.26, -7.32) and step count (498.15, 162.10, 834.20) when data were analysed across all time points.
  
  
  CONCLUSIONS
  This study suggests that a relatively low resource, pragmatic diabetes prevention programme resulted in modest benefits to biomedical, lifestyle and psychosocial outcomes, however the reduction to the risk of T2DM did not reach significance. The findings have important implications for future research and primary care.
authors.affiliation: Diabetes Research Centre, University of Leicester, Leicester, UK; Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, Leicester, UK. Electronic address: melanie.davies@uhl-tr.nhs.uk.
authors.forename: Melanie J
authors.initials: MJ
authors.lastname: Davies
authors.affiliation: Department of Health Sciences, University of Leicester, Leicester, UK. Electronic address: lg48@le.ac.uk.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Gray
authors.affiliation: Leicester Diabetes Centre, University Hospitals of Leicester, Leicester, UK. Electronic address: Jacqui.Troughton@uhl-tr.nhs.uk.
authors.forename: Jacqui
authors.initials: J
authors.lastname: Troughton
authors.affiliation: Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK. Electronic address: alastair.gray@dph.ox.ac.uk.
authors.forename: Alastair
authors.initials: A
authors.lastname: Gray
authors.affiliation: Centre for Vascular Prevention, Danube University Krems, 3500 Krems, Austria; Department of Chronic Disease Prevention, National Institute for Health and Welfare, 00271 Helsinki, Finland; Diabetes Research Group, King Abdulaziz University, 21589 Jeddah, Saudi Arabia. Electronic address: jaakko.tuomilehto@thl.fi.
authors.forename: Jaakko
authors.initials: J
authors.lastname: Tuomilehto
authors.affiliation: Diabetes Research Centre, University of Leicester, Leicester, UK. Electronic address: azhar_farooqi@hotmail.com.
authors.forename: Azhar
authors.initials: A
authors.lastname: Farooqi
authors.affiliation: Diabetes Research Centre, University of Leicester, Leicester, UK. Electronic address: kk22@le.ac.uk.
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Khunti
authors.affiliation: Diabetes Research Centre, University of Leicester, Leicester, UK; Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, Leicester, UK. Electronic address: ty20@le.ac.uk.
authors.forename: Thomas
authors.initials: T
authors.lastname: Yates
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D057187:Independent Living; D008019:Life Style; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D011236:Prediabetic State / Q000175:diagnosis; D011322:Primary Prevention / Q000193:education*; D015397:Program Evaluation; D040242:Risk Reduction Behavior; D006113:United Kingdom
keywords: Clinical trial; Lifestyle; Pre-diabetes; Prevention; Type 2 diabetes