UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of dietary habits and lifestyle of the Shizuoka citizens
Acronym	Investigation of dietary habits and lifestyle of the Shizuoka citizens
Scientific Title	Investigation of dietary habits and lifestyle of the Shizuoka citizens
Scientific Title:Acronym	Investigation of dietary habits and lifestyle of the Shizuoka citizens
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the actual dietary habits and lifestyle of Shizuoka citizens by region, gender and age.
Basic objectives2	Others
Basic objectives -Others	To clarify the relationship of dietary habits and lifestyle with health status, and the factors that related to food intake.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Dietary intake
Key secondary outcomes	Dietary habits, lifestyle, health awareness, health status (height, weight, biochemical parameters, medical history, medication)

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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Shizuoka citizens who were randomly selected and returned the completed questionnaire with agreement to written research explanation.
Key exclusion criteria	Not applicable
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Toshiko Middle name Last name Kuwano
Organization	University of Shizuoka
Division name	School of Food and Nutritional Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
TEL	054-264-5513
Email	kuwano@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Toshiko Middle name Last name Kuwano
Organization	University of Shizuoka
Division name	School of Food and Nutritional Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
TEL	054-264-5513
Homepage URL
Email	kuwano@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	University of Shizuoka
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of the University of Shizuoka
Address	52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
Tel	054-264-5103
Email	tyous10@u-shizuoka-ken.ac.jp

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	静岡市（静岡県） City of Shizuoka (Shizuoka)

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 08 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	2019 Year 08 Month 26 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cross-sectional study The subjects were randomly selected by region, gender and age, by the health promotion division of City of Shizuoka. A questionnaire was mailed in November 2019.

Management information
Registered date	2020 Year 05 Month 08 Day
Last modified on	2020 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046026

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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