UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060385 |
|---|---|
| Receipt number | R000069071 |
| Scientific Title | Evaluative study on the effect of using the Fukuoka Health Point App on lifestyle habits and nutritional status |
| Date of disclosure of the study information | 2026/01/16 |
| Last modified on | 2026/01/16 22:07:33 |
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Basic information
Public title
Evaluative study on the effect of using the Fukuoka Health Point App on lifestyle habits and nutritional status
Acronym
Fukuoka Health App Study
Scientific Title
Evaluative study on the effect of using the Fukuoka Health Point App on lifestyle habits and nutritional status
Scientific Title:Acronym
Health App Indicator Study
Region
| Japan |
Condition
Condition
Healthy adults, prevention of lifestyle-related diseases
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively clarify the impact of 2-week usage of a health point app on health behaviors and nutritional, metabolic, and oxidative stress indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from baseline in urinary indicators (ketone bodies, urine specific gravity, oxidative stress level)
Key secondary outcomes
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
| Other |
Interventions/Control_1
Use a digital health point app for 2 weeks and perform urine tests at the start and end of use.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ndividuals residing, working, or attending school in the study area (Fukuoka Prefecture)
Individuals who own a smartphone capable of using the health point app
Individuals who understood the purpose of the study and consented to participate in writing
Key exclusion criteria
Individuals with serious underlying diseases (renal failure, heart failure, etc.)
Pregnant or breastfeeding individuals
Others judged inappropriate by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Miyoshi |
Organization
ASTEM Co., Ltd.
Division name
Regional Access Section, Regional Access Department
Zip code
8120007
Address
3-1-2 Higashihie, Hakata-ku, Fukuoka-shi, Fukuoka
TEL
092-409-1624
miyoshi09a@forestg.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Miyoshi |
Organization
ASTEM Co., Ltd.
Division name
Regional Access Section, Regional Access Department
Zip code
812-0007
Address
3-1-2 Higashihie, Hakata-ku, Fukuoka-shi, Fukuoka
TEL
092-409-1624
Homepage URL
miyoshi09a@forestg.jp
Sponsor or person
Institute
ASTEM Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Yuurea Co., Ltd.
Address
3F Nagono Campus, 2-14-1 Nagono, Nishi-ku, Nagoya-shi, Aichi
Tel
050-3717-0358
ushijima.takuto@yuurea.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
| 2026 | Year | 01 | Month | 16 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2026 | Year | 01 | Month | 16 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069071
