UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008163 |
|---|---|
| Receipt number | R000009612 |
| Scientific Title | 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 14:32:54 |
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Basic information
Public title
Evaluation of a community intervention program in Japan Using Framingham risk score and estimated 10-year CHD risk as outcome variables
Acronym
Framingham risk score in an intervention program
Scientific Title
Evaluation of a community intervention program in Japan Using Framingham risk score and estimated 10-year CHD risk as outcome variables
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Bing Zhu, Yasuo Haruyama, Takashi Muto |
Organization
Dokkyo Medical University School of Medicine, Tochigi, Japan
Division name
Department of Public Health
Zip code
Address
880 Kitakobayashi, Mibu-City, Tochigi 321-0293, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Dokkyo Medical University School of Medicine, Tochigi, Japan
Division name
Department of Public Health
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009612
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
