UMIN-CTR Clinical Trial

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

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

Institute

Department

Personal name



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

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