UMIN-CTR Clinical Trial

Basic information
Public title	An observational study on lifestyle, health and psychological state. (SWE-2021-02)
Acronym	An observational study on lifestyle, health and psychological state.
Scientific Title	An observational study on lifestyle, health and psychological state. (SWE-2021-02)
Scientific Title:Acronym	An observational study on lifestyle, health and psychological state.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between psychological state and lifestyle and health conditions.
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between psychological state and lifestyle and health conditions.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	psychological state
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Women and men aged 20 to 79 years. (2) Persons who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria	(1) Persons who have been diagnosed with having a cranial nerve system disease (dementia, cerebral infarction, cerebral hemorrhage, stroke, etc.) in the past. (2) Persons who have been diagnosed with having a mental illness (depression, schizophrenia, anxiety disorder, etc.) in the past. (3) Persons who takes sleeping pills, anxiolytics, and antidepressants. (4) Pregnant (including those who may be pregnant) or lactating. (5) Others who are judged by the principal investigator to be inappropriate for research.
Target sample size	960

Research contact person
Name of lead principal investigator	1st name Yoshihisa Middle name Last name Kaneda
Organization	Suntory Wellness Limited
Division name	Institute for Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0654
Email	Yoshihisa_Kaneda@suntory.co.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Morita
Organization	Suntory Wellness Limited
Division name	Institute for Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0520
Homepage URL
Email	Sa_Morita@suntory.co.jp

Sponsor
Institute	Suntory Wellness Limited
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguro-ku, Tokyo
Tel	03-6452-2712
Email	nakagawa.akiko297@eps.co.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

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 28 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	2022 Year 02 Month 11 Day
Date of IRB	2022 Year 02 Month 10 Day
Anticipated trial start date	2022 Year 03 Month 01 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study To investigate the relationship between psychological state and lifestyle and health conditions.

Management information
Registered date	2022 Year 02 Month 24 Day
Last modified on	2022 Year 08 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053606