title: The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data.
abstract: BACKGROUND
  Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae. Metabolic syndrome (MetS) comprises a constellation of factors that increase the risk of cardiovascular disease (CVD) and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data.
  
  
  METHODS
  Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up.
  
  
  RESULTS
  82 participants (44% male, 22% South Asian) were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42) and control groups (n = 40). Median age was 63 years (IQR 57 - 67), mean waist size 106 cm (SD ± 11), and prescribing of statins and anti-hypertensives was 51% in each case.
  
  
  CONCLUSIONS
  Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable.
  
  
  BACKGROUND
  The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.
authors.affiliation: Department of Health Sciences, University of Leicester, Leicester, UK. ajd38@le.ac.uk
authors.forename: Alison J
authors.initials: AJ
authors.lastname: Dunkley
authors.forename: Melanie J
authors.initials: MJ
authors.lastname: Davies
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Stone
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Taub
authors.forename: Jacqui
authors.initials: J
authors.lastname: Troughton
authors.forename: Thomas
authors.initials: T
authors.lastname: Yates
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Khunti
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D044466:Asian People / Q000706:statistics & numerical data; D002318:Cardiovascular Diseases / Q000208:ethnology / Q000209:etiology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000208:ethnology / Q000209:etiology / Q000517:prevention & control*; D050171:Dyslipidemias / Q000150:complications / Q000628:therapy; D004739:England / Q000453:epidemiology; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D006973:Hypertension / Q000150:complications / Q000628:therapy; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications / Q000175:diagnosis / Q000208:ethnology / Q000628:therapy*; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000628:therapy; D010353:Patient Education as Topic; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012648:Self Care; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055105:Waist Circumference; D044465:White People / Q000706:statistics & numerical data
chemical_list: D000959:Antihypertensive Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors