UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045749
Receipt number R000052228
Scientific Title Investigation of the objective evaluation and interrelationship between the residential food environment and dietary habits and lifestyle-related diseases
Date of disclosure of the study information 2021/10/14
Last modified on 2022/04/15 09:54:18

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Basic information

Public title

Investigation of residential environment and dietary habits and lifestyle-related diseases

Acronym

Investigation of residential environment and dietary habits and lifestyle-related diseases

Scientific Title

Investigation of the objective evaluation and interrelationship between the residential food environment and dietary habits and lifestyle-related diseases

Scientific Title:Acronym

Investigation of residential environment and dietary habits and lifestyle-related diseases

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship of the residential environment and residents' dietary habits, lifestyle, and health status.

Basic objectives2

Others

Basic objectives -Others

To clarify the relationship of the residential environment and residents' dietary habits, lifestyle, and health status.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Health status

Key secondary outcomes

Dietary habits, lifestyle, health awareness, and dietary intake


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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Male

Key inclusion criteria

Male aged 30-59 years old

Key exclusion criteria

(1) Participants who declined to provide health examination results.
(2) Participants with missing answers to the assessment questions.

Target sample size

200


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 or person

Institute

University of Shizuoka

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

岐阜車体工業株式会社(岐阜県)


Other administrative information

Date of disclosure of the study information

2021 Year 10 Month 14 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

2021 Year 06 Month 28 Day

Date of IRB

2021 Year 09 Month 02 Day

Anticipated trial start date

2021 Year 10 Month 01 Day

Last follow-up date

2021 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
To investigate the relationship between the residential environment and residents' dietary habits, lifestyle, and health status.


Management information

Registered date

2021 Year 10 Month 14 Day

Last modified on

2022 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052228