UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Lifestyle-related diseases and frailty
Classification by specialty	Medicine in general Geriatrics Not applicable Adult
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.
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.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
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.
Key exclusion criteria	Not applicable.
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ichiei Narita
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
Email	naritai@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Junta Tanaka
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/
Email	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
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	2015 Year 05 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 05 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Baseline survey completed.

Management information
Registered date	2015 Year 05 Month 25 Day
Last modified on	2018 Year 01 Month 11 Day

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

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