Unique ID issued by UMIN | UMIN000000915 |
---|---|
Receipt number | R000001103 |
Scientific Title | Worksite intervention study of a lifestyle modification program for men with the metabolic syndrome: the Tsurumi Health Study (THS) |
Date of disclosure of the study information | 2007/12/15 |
Last modified on | 2008/12/09 13:31:49 |
Worksite intervention study of a lifestyle modification program for men with the metabolic syndrome: the Tsurumi Health Study (THS)
Lifestyle modification program for metabolic syndrome
Worksite intervention study of a lifestyle modification program for men with the metabolic syndrome: the Tsurumi Health Study (THS)
Lifestyle modification program for metabolic syndrome
Japan |
metabolic syndrome
Endocrinology and Metabolism |
Others
NO
Does a behavioral education program for male workers with metabolic syndrome improve 1) metabolic status, and 2) lifestyle factors and biomarkers related to colorectal cancer risk?
Efficacy
Confirmatory
Pragmatic
Not applicable
The prevalence of metabolic syndrome at 6 month
(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
Interventional
Cross-over
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Educational,Counseling,Training
Behavior,custom |
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.
Not applicable |
Not applicable |
Male
Waist circumference: 85 cm or greater
plus positive at least 2 factors below.
1) fasting glucose, 110 mg/dl or higher
2) HDL-cholesterol, less than 40 mg/dl and/or triglyceride, 150 mg/dl or higher
3) systolic blood pressure, 130 mmHg or higher and/or diastolic blood pressure, 85 mmHg or higher
* Those on medication for diabetes or hypertension are regarded as positive for the corresponding item, whereas those on medication on hyperlipidemia are not.
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
100
1st name | |
Middle name | |
Last name | Tetsuya Mizoue |
International Medical Center of Japan, Research Institute
Department of Epidemiology and International Health
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
03-3202-7181
1st name | |
Middle name | |
Last name | Tetsuya Mizoue |
International Medical Center of Japan, Research Institute
Department of Epidemiology and International Health
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
03-3202-7181
mizoue@ri.imcj.go.jp
Department of Epidemiology and International Health, Research Institute, International Medical Center of Japan
Ministry of Health, Labour and Welfare
Japan
Tsurumi Health Center
NO
2007 | Year | 12 | Month | 15 | Day |
Unpublished
No longer recruiting
2007 | Year | 09 | Month | 13 | Day |
2007 | Year | 10 | Month | 01 | Day |
2009 | Year | 10 | Month | 01 | Day |
2007 | Year | 11 | Month | 30 | Day |
2008 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001103
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |