title: Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study.
abstract: BACKGROUND
  The successful Greater Green Triangle Diabetes Prevention Program (GGT DPP), a small implementation trial, has been scaled-up to the Victorian state-wide 'Life!' programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS) is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS) of this evaluation.
  
  
  METHODS
  The pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance.
  
  
  RESULTS
  Intervention participants significantly improved at 12 months in mean body mass index (-0.98 kg/m(2), standard error (SE) = 0.26), weight (-2.65 kg, SE = 0.72), waist circumference (-7.45 cm, SE = 1.15), and systolic blood pressure (-3.18 mmHg, SE = 1.26), increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE = 0.03), reduced energy from total (-2.00%, SE = 0.78) and saturated fat (-1.54%, SE = 0.41), and increased fibre intake (1.98 g/1,000 kcal energy, SE = 0.47). In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE = 0.27). Only waist circumference reduced significantly (-4.02 cm, SE = 0.95).Intervention participants significantly outperformed controls over 12 months for body mass index and fibre intake. After baseline adjustment, they also showed greater weight loss and reduced saturated fat versus total energy intake.At least 5% weight loss was achieved by 32% of intervention participants versus 0% controls.
  
  
  CONCLUSIONS
  pMDPS results indicate that scaling-up from implementation trial to state-wide programme is possible. The system design for Life! was fit for purpose of scaling-up from efficacy to effectiveness.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry ACTRN12609000507280.
authors.affiliation: Greater Green Triangle University Department of Rural Health, Flinders University and Deakin University, PO Box 423, Warrnambool, VIC 3280, Australia.
authors.forename: Edward D
authors.initials: ED
authors.lastname: Janus
authors.forename: James D
authors.initials: JD
authors.lastname: Best
authors.forename: Nathalie
authors.initials: N
authors.lastname: Davis-Lameloise
authors.forename: Benjamin
authors.initials: B
authors.lastname: Philpot
authors.forename: Andrea
authors.initials: A
authors.lastname: Hernan
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Bennett
authors.forename: Sharleen
authors.initials: S
authors.lastname: O'Reilly
authors.forename: Rob
authors.initials: R
authors.lastname: Carter
authors.forename: Erkki
authors.initials: E
authors.lastname: Vartiainen
authors.forename: James A
authors.initials: JA
authors.lastname: Dunbar
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure; D015992:Body Mass Index; D031204:Caloric Restriction; D016009:Chi-Square Distribution; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D002149:Energy Intake; D015444:Exercise; D005260:Female; D005951:Glucose Tolerance Test; D006126:Group Processes; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011322:Primary Prevention / Q000379:methods*; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome; D014739:Victoria / Q000453:epidemiology; D055105:Waist Circumference; D015431:Weight Loss
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D008078:Cholesterol, LDL