Effects of a lifestyle modification programme to reduce the number of risk factors for metabolic syndrome: a randomised controlled trial.

Objective: To determine the effectiveness of a personal support lifestyle education programme (PSMetS) for reducing risk factors in individuals with metabolic syndrome (MetS). Design: A two-arm randomised controlled trial. Setting: Companies in metropolitan Tokyo, Japan. Subjects: Male workers with diagnosed MetS or a high risk for MetS according to the Counselling Guidance Program, Japan (n 193). Results: The reduction in the number of risk factors for MetS (as defined according to the criteria published by the Japanese Ministry of Health, Labor and Welfare in April 2007 (MHLW-MetS)) in the PSMetS group was not significantly different from that in the usual care group by van Elteren's test (baseline-adjusted P= 0.075) for intention-to-treat (ITT), while it was significant (baseline-adjusted P= 0.038) for per-protocol set (PPS). The proportion of MHLW-MetS was significantly different between groups by van Elteren's test (baseline-adjusted P= 0.031). Two components of MHLW-MetS showed significant reductions in the PSMetS group: waist circumference (baseline-adjusted P= 0.001) and BMI (baseline-adjusted P= 0.002). PPS and ITT analyses showed similar results. Conclusions: For male workers with MHLW-MetS or a high risk of MHLW-MetS, PSMetS reduced the number of risk factors for MHLW-MetS.