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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008163
Receipt No. R000009612
Official scientific title of the study Evaluation of a community intervention program in Japan Using Framingham risk score and estimated 10-year CHD risk as outcome variables
Date of disclosure of the study information 2012/06/13
Last modified on 2012/06/13

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Basic information
Official scientific title of the study Evaluation of a community intervention program in Japan Using Framingham risk score and estimated 10-year CHD risk as outcome variables
Title of the study (Brief title) Framingham risk score in an intervention program
Region
Japan

Condition
Condition coronary disease; cardiovascular disease
Classification by specialty
Cardiology Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study was to assess the effects of a program involving a 6-month intervention and 18-month follow-up using such outcomes.
Basic objectives2 Others
Basic objectives -Others coronary disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes estimated 10-year CHD risk;Framingham risk score
Key secondary outcomes cardiovascular risk factors

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group
Interventions/Control_2 Control group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Waist circumference>=85cm for males, >=90cm for females or <85cm for males, <90cm for females, and body mass index(BMI) >=25kg/m2;
Hemoglobin (HbA1c) >5.6% or taking diabetes medication; Triglycerides (TG)>150mg/dl or high-density lipoprotein cholesterol (HDL-C) < 40mg/dl or taking lipid-lowering medication; systolic blood pressure (SBP) >=130mmHg or diastolic blood pressure (DBP)>=85mmHg or taking hypertension medication; having a history of smoking.
Key exclusion criteria having history of cardiovascular disease
Target sample size 2000

Research contact person
Name of lead principal investigator Bing Zhu, Yasuo Haruyama, Takashi Muto
Organization Dokkyo Medical University School of Medicine, Tochigi, Japan
Division name Department of Public Health
Address 880 Kitakobayashi, Mibu-City, Tochigi 321-0293, Japan
TEL
Email

Public contact
Name of contact person
Organization Dokkyo Medical University School of Medicine, Tochigi, Japan
Division name Department of Public Health
Address
TEL
Homepage URL
Email

Sponsor
Institute Dokkyo Medical University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization This study was supported in part by Japan China Sasakawa Medical Fellowship.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

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
2012 Year 06 Month 13 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2008 Year 01 Month 01 Day
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2012 Year 06 Month 13 Day
Last modified on
2012 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009612


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