Worksite intervention study of a lifestyle modification program for men with the metabolic syndrome: the Tsurumi Health Study (THS)
Not Applicable
- Conditions
- metabolic syndrome
- Registration Number
- JPRN-UMIN000000915
- Lead Sponsor
- Department of Epidemiology and International Health, Research Institute, International Medical Center of Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
a) Persons with a history of cerebrovascular diseases, myocardial infarction, cancer, or other severe diseases. b) Persons on medical treatment for diabetes or those who have fasting glucose of 140 mg/dl or higher c) Persons with systolic blood pressure of 180 mmHg or higher and/or diastolic blood pressure of 110 mmHg or higher, or with triglyceride of 1000 mg/dl or higher d) Persons who can not do exercise due to musculoskeletal problem e) Persons who have no intention or are unable to improve their lifestyle f) Persons who can not participate follow-up surveys g) Persons in conditions that are judged as ineligible by a occupational physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The prevalence of metabolic syndrome at 6 month
- Secondary Outcome Measures
Name Time Method (Changes between baseline and 6 month) 1) waist circumference, body weight, body mass index, systolic blood pressure, diastolic blood pressure, glucose, HDL cholesterol, triglyceride 2) diet: energy-adjusted intakes of vegetables, fruits, dairy foods (milk), dietary fiber, calcium, magnesium, and folate. Alcohol consumption. 3) Changes of physical activity: weekly hours or MET-hours of activities on leisure-time and transportation from home to work 4) Prevalence of smoking 5) Biochemical parameters:(blood) hemoglobin A1c, C-peptide, high-sensitivity C-reactive protein, IL-6, adiponectin, vitamin D, folate, homocysteine, alpha- and beta-carotenes, insulin-like growth factor-I (IGF-I), insulin-like growth factor binding protein 1 (IGFBP-1), insulin-like growth factor binding protein-3 (IGFBP-3), fatty acid composition, (urine) 8-hydroxydeoxyguanosine, isoprostane 6) depression score(CES-D) 7) Changes of the above items at 1 year