UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052270 |
|---|---|
| Receipt number | R000059668 |
| Scientific Title | Project to review the lifestyle habits of the working generation |
| Date of disclosure of the study information | 2023/09/21 |
| Last modified on | 2024/03/22 11:49:41 |
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Basic information
Public title
Project to review the lifestyle habits of the working generation
Acronym
Project to review the lifestyle habits of the working generation
Scientific Title
Project to review the lifestyle habits of the working generation
Scientific Title:Acronym
Project to review the lifestyle habits of the working generation
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in health awareness and behavioral changes through the blood sugar spike test ``Spike Check'' and a 4-week health program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in health awareness before and after project implementation
Key secondary outcomes
Relationship between health program continuation rate and urinary myo-inositol levels
Relationship between health program continuation rate and lifestyle habits
Changes in urinary myo-inositol before and after the project
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform a blood glucose spike test and then continue the health program for 4 weeks. After that, those who wish will perform the blood sugar spike test again.
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.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Adults who are 18years old or more
3.Employees of businesses registered with Okazaki Health Declaration Business Offices
Key exclusion criteria
1.Persons who have kidney disease or diabetes
2.Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Nishiwaki |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
446-0058
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
TEL
052-734-8885
nishiwaki@hc-sys.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Okuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Sales Planning Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
okuda.saeko@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Aichi Prefectural Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kobayashi Create Co.,Ltd.
KAGOME CO.,LTD.
OTA OIL CO.,LTD.
MARUSAN-AI CO., LTD.
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 09 | Month | 21 | 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
314
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
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059668
