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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

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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
Interventions/Control_2
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

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
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
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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