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Recruitment
status
F Enrolling by invitation
(outpatients are not recruited publicly)
Unique trial Number : UMIN000008163
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 formal registration
(=Date of ICMJE and WHO compliant trial information registration and disclosure)
: 2012/06/13
Date and time of last update : 2012/06/13 14:32:54

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


Objectives
Item Value
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
Item Value
Primary outcomes estimated 10-year CHD risk;Framingham risk score
Key secondary outcomes cardiovascular risk factors


Base
Item Value
Study type Interventional


Study design
Item Value
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
Item Value
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


Eligibility
Item Value
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
Item Value
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
Item Value
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
Item Value
Name of primary sponsor Dokkyo Medical University School of Medicine

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
Item Value
Source of funding This study was supported in part by Japan China Sasakawa Medical Fellowship.
Category of Org. Non profit foundation
Nation of funding


Other related organizations
Item Value
Name of secondary sponsor(s)
Name of secondary funer(s)


Secondary study IDs
Item Value
Secondary study IDs NO
Secondary study ID_1
Org. issuing Secondary study ID_1
Secondary study ID_2
Org. issuing Secondary study ID_2
IND to MHLW


Institutions
Item Value
Institutions


Progress
Item Value
Recruitment status Enrolling by invitation
(outpatients are not recruited publicly)
Date of protocol fixation 2008/01/01
Anticipated trial start date 2008/03/01
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded


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Publication of results Unpublished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


Item Value
Date of registration 2012/06/13
Date of last update 2012/06/13 14:32:54