Worksite intervention study of a lifestyle modification program for men with the metabolic syndrome: the Tsurumi Health Study (THS)

UMIN ID: UMIN000000915

Registered date:15/12/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: metabolic syndrome
• Date of first enrollment: 2007/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Tailor-made counseling on lifestyle modifications, including goal setting, use of motivational tools, record of body weight. Specific dietary advice to increase the consumption of fruits, vegetables and dairy foods, and to decrease consumptions of foods/dishes high in calorie or fat and alcohol beverage. Advice on quitting smoking for those who have an intention to quit. These counseling are provided on face-to-face method at baseline, 1 month, and 3 month.
Standard counseling on lifestyle modifications using pamphlet designed for metabolic syndrome, with one follow up counseling at 3 month by e-mail or telephone.

Outcome(s)

• Primary Outcome: The prevalence of metabolic syndrome at 6 month
• Secondary Outcome: (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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male
• Exclude 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

Related Information

• Primary Sponsor: Department of Epidemiology and International Health, Research Institute, International Medical Center of Japan
• Secondary Sponsor: Tsurumi Health Center
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare