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JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000915

Registered date:15/12/2007

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedmetabolic syndrome
Date of first enrollment2007/10/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeThe 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 minimumNot applicable
Age maximumNot applicable
GenderMale
Include criteria
Exclude criteriaa) 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

Contact

public contact
Name Tetsuya Mizoue
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan Japan
Telephone 03-3202-7181
E-mail mizoue@ri.imcj.go.jp
Affiliation International Medical Center of Japan, Research Institute Department of Epidemiology and International Health
scientific contact
Name Tetsuya Mizoue
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan Japan
Telephone 03-3202-7181
E-mail
Affiliation International Medical Center of Japan, Research Institute Department of Epidemiology and International Health