UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058099 |
|---|---|
| Receipt number | R000066400 |
| Scientific Title | A study to evaluate the usefulness of a behavior change application in healthy middle-aged subjects -a randomized, single-blind, parallel group comparative study |
| Date of disclosure of the study information | 2025/06/09 |
| Last modified on | 2025/06/05 18:47:59 |
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Basic information
Public title
A study to evaluate the usefulness of a behavior change application
Acronym
A study to evaluate the usefulness of a behavior change the application
Scientific Title
A study to evaluate the usefulness of a behavior change application in healthy middle-aged subjects -a randomized, single-blind, parallel group comparative study
Scientific Title:Acronym
A study to evaluate the usefulness of a behavior change application in healthy middle-aged subjects -a randomized, single-blind, parallel group comparative study
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the usefulness of a behavior change application
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1:Number of remaining supplements
2:Number of missed doses
3:Withdrawal rate of supplement intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
message intervention by the application
Interventions/Control_2
control(No message intervention)
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1:Male and females whose age is between 35 and 60 at the time of obtaining consent
2:Subjects who use Japanese as his/her primary language
3:Subjects who intend to take supplements to improve their health
4:Subjects who use LINE on a daily basis
Key exclusion criteria
1:Subjects with no history of dietary supplement use
2:Subjects who are currently taking supplements
3:Subjects who consume health-related foods (including beverages) on a daily basis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Arakawa |
Organization
Kyushu University
Division name
Faculty of Information Science and Electrical Engineering
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka City, Fukuoka Japan
TEL
092-802-3794
arakawa@ait.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yamakoshi |
Organization
Kirin Holdings Company, Limited
Division name
Kirin Central Research Institute, Research & Development Division
Zip code
251-8555
Address
26-1-12-12 Muraoka-Higashi 2-chome Fujisawa Kanagawa Japan
TEL
070-3943-8547
Homepage URL
Tatsuya_Yamakoshi@kirin.co.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Graduate School of Information Science and Electrical Engineering Experimental Ethics Committee
Address
744 Motooka, Nishi-ku, Fukuoka City, Fukuoka Japan
Tel
092-802-2405
koegsuisin@jimu.kyushu-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 09 | 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
| 2025 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066400
