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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000915
Receipt No. 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

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Basic information
Public title Worksite intervention study of a lifestyle modification program for men with the metabolic syndrome: the Tsurumi Health Study (THS)
Acronym Lifestyle modification program for metabolic syndrome
Scientific Title Worksite intervention study of a lifestyle modification program for men with the metabolic syndrome: the Tsurumi Health Study (THS)
Scientific Title:Acronym Lifestyle modification program for metabolic syndrome
Region
Japan

Condition
Condition metabolic syndrome
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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?
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The prevalence of metabolic syndrome at 6 month
Key secondary outcomes (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

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 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.
Interventions/Control_2 Standard counseling on lifestyle modifications using pamphlet designed for metabolic syndrome, with one follow up counseling at 3 month by e-mail or telephone.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 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.
Key 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Mizoue
Organization International Medical Center of Japan, Research Institute
Division name Department of Epidemiology and International Health
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Mizoue
Organization International Medical Center of Japan, Research Institute
Division name Department of Epidemiology and International Health
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email mizoue@ri.imcj.go.jp

Sponsor
Institute Department of Epidemiology and International Health, Research Institute, International Medical Center of Japan
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tsurumi Health Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2007 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2009 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 11 Month 30 Day
Last modified on
2008 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.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


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