UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051726 |
|---|---|
| Receipt number | R000059038 |
| Scientific Title | Observational study on cheering activities (SWE-2023-01) |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/27 13:50:02 |
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Basic information
Public title
Observational study on cheering activities (SWE-2023-01)
Acronym
Observational study on cheering activities (SWE-2023-01)
Scientific Title
Observational study on cheering activities (SWE-2023-01)
Scientific Title:Acronym
Observational study on cheering activities
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the relationship between various lifestyle and health indicators.
Basic objectives2
Others
Basic objectives -Others
Examine the relationship between various lifestyle and health indicators.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
psychological state and health indicators
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Men and women who are ages 18 and over.
(2) Persons who meet the condition 2-1, 2-2, or 2-3 below.
2-1. Users of the nursing home participating in J-league games cheering
2-2. Employees of the nursing home participating in J-league games cheering who can answer the questionnaire
2-3. Family members of 2-1 who can answer the questionnaire*1
(3) Persons who fully understand the purpose and content of this study and have given their written consent.
*1: One corresponding family member is to be a 2-3 research subject for each 2-1 research subject
Key exclusion criteria
(1)Users of the nursing home who have never participated in J-league games cheering in the past
(2)Employees of the nursing home who have never participated in J-league games cheering in the past
(3)The nursing home users who plan to move to another nursing home during the study period.
(4)Employees of the nursing home or family members of the nursing home users who have had or are scheduled to have a life event (e.g., resignation, job change, moving to a new location, moving alone, etc.) affecting the study from 4 weeks prior to the beginning of the study to the end of the study
(5)Other subjects deemed inappropriate as the study subject by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Kaneda |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
6190284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
05031820654
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 Science of Life
Zip code
6190284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
05031820520
Homepage URL
Sa_Morita@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
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
Miura Clinic, Medical Corporation Kanonkai
Address
9F, Higashitemma Bldg. 1-7-17 Higashitemma, Kita-ku, Osaka, Japan
Tel
0661355200
info@miura-cl.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
| 2023 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examine the relationship between various lifestyle and health indicators.
Management information
Registered date
| 2023 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059038
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
