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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000017671 |
Receipt No. | R000020486 |
Scientific Title | Yuzawa town residents' "Onsen" bathing, diet, exercise and life-style analyses on health, frailty and nursing care prevention; YODEL study |
Date of disclosure of the study information | 2015/05/25 |
Last modified on | 2018/01/11 |
Basic information | ||
Public title | Yuzawa town residents' "Onsen" bathing, diet, exercise and life-style analyses on health, frailty and nursing care prevention; YODEL study | |
Acronym | Community health survey in Yuzawa-town; Yuzawa cohort study | |
Scientific Title | Yuzawa town residents' "Onsen" bathing, diet, exercise and life-style analyses on health, frailty and nursing care prevention; YODEL study | |
Scientific Title:Acronym | Community health survey in Yuzawa-town; Yuzawa cohort study | |
Region |
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Condition | |||||
Condition | Lifestyle-related diseases and frailty | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To clarify the impact of bathing, diet, exercise and lifestyle on progression of the lifestyle-related diseases and frailty.
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Basic objectives2 | Others |
Basic objectives -Others | To evaluate morbidity and mortality rate and risk
of cerebrovascular, malignant and cardiovascular diseases, which are the specific health concerns of Yuzawa-town. |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. Morbidity and mortality rate of cerebrovascular, malignant and cardiovascular diseases.
2. Detection of risk factors on progression of lifestyle-related diseases and frailty. |
Key secondary outcomes | Subsidiary research on relationship between environmental factors and biomarkers, as well as muscle strength.
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Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | A. Health and lifestyle-related questionnaire: residents of Yuzawa-town
B. Donation of health checkup data, blood and urine samples: health checkup examinees of Yuzawa-town. |
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Key exclusion criteria | Not applicable. | |||
Target sample size | 5000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Niigata University | ||||||
Division name | Department of Health Promotion Medicine | ||||||
Zip code | |||||||
Address | 1-757 Asahimachi-dori, Chuo-ku, Niigata-city, Niigata, Japan. | ||||||
TEL | 025-227-2192 | ||||||
naritai@med.niigata-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Niigata University | ||||||
Division name | Department of Health Promotion Medicine | ||||||
Zip code | |||||||
Address | 1-757 Asahimachi-dori, Chuo-ku, Niigata-city, Niigata, Japan. | ||||||
TEL | 025-368-9009 | ||||||
Homepage URL | https://www.facebook.com/NUHPM/ | ||||||
juntatnk@med.niigata-u.ac.jp |
Sponsor | |
Institute | Niigata University |
Institute | |
Department |
Funding Source | |
Organization | Niigata-prefecture |
Organization | |
Division | |
Category of Funding Organization | Local Government |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Yuzawa-town |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Anticipated trial start date |
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Other | |
Other related information | Baseline survey completed. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020486 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |