UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058889 |
|---|---|
| Receipt number | R000067346 |
| Scientific Title | The proposal and implementation of novel health promotion support functions for local residents and the evaluation of changes in awareness and behavior |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/25 15:47:33 |
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Basic information
Public title
The proposal and implementation of novel health promotion support functions for local residents and the evaluation of changes in awareness and behavior
Acronym
The proposal and implementation of novel health promotion support functions for local residents and the evaluation of changes in awareness and behavior
Scientific Title
The proposal and implementation of novel health promotion support functions for local residents and the evaluation of changes in awareness and behavior
Scientific Title:Acronym
The proposal and implementation of novel health promotion support functions for local residents and the evaluation of changes in awareness and behavior
Region
| Japan |
Condition
Condition
not limited
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify issues related to health promotion functions and consider support methods that lead to changes in residents' awareness and behavior, thereby providing health support according to residents' life stages.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A questionnaire survey to confirm changes in awareness and behavior through gamification apps (planned: immediately after app use, one month later, and six months later)
Key secondary outcomes
Confirm trends in residents' backgrounds that utilize health support functions, identify areas for improvement in the app, and consider methods for providing health support.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use of an app developed to raise awareness of dietary management
After being introduced at a health promotion event, it was used for about six months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
20 years of age or older
Able to answer the questionnaire yourself
Able to operate the app yourself
Key exclusion criteria
Those who did not agree to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Yahara |
Organization
Hyogo Medical University
Division name
School of Pharmacy
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3000
me-yahara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Yahara |
Organization
Hyogo Medical University
Division name
School of Pharmacy
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3000
Homepage URL
me-yahara@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Review Committee of the president of Hyogo Medical University
Address
1-1, Mukogawacho Nishinomiya, Hyogo
Tel
079-845-6066
rinri@hyo-med.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 | 08 | Month | 25 | 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 | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 01 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067346
