The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data

Trials. 2011 May 4;12:107. doi: 10.1186/1745-6215-12-107.

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.

Conclusion: 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.

Trial registration: The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antihypertensive Agents / therapeutic use
  • Asian Continental Ancestry Group / statistics & numerical data
  • Cardiovascular Diseases / ethnology
  • Cardiovascular Diseases / etiology
  • Cardiovascular Diseases / prevention & control*
  • Diabetes Mellitus, Type 2 / ethnology
  • Diabetes Mellitus, Type 2 / etiology
  • Diabetes Mellitus, Type 2 / prevention & control*
  • Dyslipidemias / complications
  • Dyslipidemias / therapy
  • England / epidemiology
  • European Continental Ancestry Group / statistics & numerical data
  • Female
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
  • Hypertension / complications
  • Hypertension / therapy
  • Male
  • Metabolic Syndrome / complications
  • Metabolic Syndrome / diagnosis
  • Metabolic Syndrome / ethnology
  • Metabolic Syndrome / therapy*
  • Middle Aged
  • Obesity / complications
  • Obesity / therapy
  • Patient Education as Topic*
  • Research Design*
  • Risk Assessment
  • Risk Factors
  • Risk Reduction Behavior*
  • Self Care*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Waist Circumference

Substances

  • Antihypertensive Agents
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors

Associated data

  • ClinicalTrials.gov/NCT01043770