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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030268
Receipt No. R000034570
Scientific Title Development of the scale of the Shikohin-related behaviors.
Date of disclosure of the study information 2017/12/06
Last modified on 2018/01/18

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Basic information
Public title Development of the scale of the Shikohin-related behaviors.
Acronym Development of the scale of the Shikohin-related behaviors.
Scientific Title Development of the scale of the Shikohin-related behaviors.
Scientific Title:Acronym Development of the scale of the Shikohin-related behaviors.
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to develop the scale of the Shikohin-related behaviors
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to analysis a reliability and validity of the scale of the Shikohin-related behaviors
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Shikohin-related behaviors
Key secondary outcomes

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
20 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criterion is daily consumption of at least one of four shikohin (alcohol, tea, coffee, and tobacco)
Key exclusion criteria None
Target sample size 850

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Yokomitsu
Organization Tobacco Academic Studies Center
Division name Research Department
Zip code
Address 1-16-3, Yokokawa, Sumida-ku, Tokyo
TEL 03-6284-1522
Email yokomitsu@tasc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Yokomitsu
Organization Tobacco Academic Studies Center
Division name Research Department
Zip code
Address 1-16-3, Yokokawa, Sumida-ku, Tokyo
TEL 03-6284-1522
Homepage URL
Email yokomitsu@tasc.or.jp

Sponsor
Institute Tobacco Academic Studies Center
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Tohoku Gakuin University
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 首都圏1都3圏/the Tokyo metropolitan area (Tokyo, Kanagawa, Saitama, and Chiba)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 06 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 Completed
Date of protocol fixation
2017 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 06 Day
Last follow-up date
2017 Year 12 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This survey is delivered to potential participants' homes and voluntarily return during the study period. Participants are selected through stratified two-stage area sampling with proportional allocation.

Management information
Registered date
2017 Year 12 Month 05 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034570

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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