UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057945 |
|---|---|
| Receipt number | R000066137 |
| Scientific Title | Research and Development on Prevention and Health Promotion through Behavioral Change Smartphone App (MIRAMED) |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/05/23 14:29:16 |
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Basic information
Public title
Research and Development on Prevention and Health Promotion through Behavioral Change Smartphone App (MIRAMED)
Acronym
-
Scientific Title
Research and Development on Prevention and Health Promotion through Behavioral Change Smartphone App (MIRAMED)
Scientific Title:Acronym
-
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of the specific health guidance service using ICT (Information and Communication Technology) developed at the Center of Innovation (COI) of the University of Tokyo in order to verify lifestyle-related disease countermeasures for municipal policies and problem solving.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight and abdominal circumference change from the time of the medical checkup in the relevant year to the medical checkup in the following year.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of Specific Health Guidance.
Use of behavior change application (MIRAMED).
Responses to the research questionnaire.
Measurement of ME-BYO indicator.
Interventions/Control_2
Implementation of Specific Health Guidance.
Responses to the research questionnaire.
Measurement of ME-BYO indicator.
(The control group without continued app use will be treated as a hybrid control along with feature-aligned data from other cohorts.)
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
| 39 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Those who have undergone a specific health checkup by the National Health Insurance or company health insurance union in Kanagawa Prefecture after November 2024.
2)Those who are eligible for active support in specific health guidance through stratification by the national health insurance association or health insurance association.
3)Men and women whose age is 40 years or older and less than 75 years old in the year of health checkup
4) Subjects who have received a full explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the subject.
5) Owners of a smartphone capable of running the application (iPhone owners must have an iPhone 7 or later with iOS 14 or higher, and Android users must have Android OS 9 or higher).
6)You must be able to answer the questionnaire on the application every day for the allotted period of time, as long as possible.
7)Have been using a smartphone for at least 6 months.
8)Those who have agreed to install MY ME-BYO app and to measure the ME-BYO indicator a specified number of times.
9)Those who have undergone a medical checkup in the following year within 6 to 12 months from the start of the specified health guidance and agree to provide the information.
10)Those who can input the measurement results of weight and abdominal circumference in the sixth month from the start of the specified health guidance.
11)Those who are willing to cooperate in other surveys.
12)Those who can start participating in the specified health guidance within 6 months of the medical checkup.
Key exclusion criteria
1) Those who do not fall into the category of active support in the stratification of specific health guidance.
2) Those who are taking medication for diabetes, hypertension, or dyslipidemia at the time of the health checkup.
3) Those who are judged by the principal investigator to be obstacles to participation in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | Kishi |
| Last name | Svensson |
Organization
Graduate School of Engineering The University of Tokyo
Division name
Precision Health, Department of Bioengineering
Zip code
113-8656
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5481-6696
akishi@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Sugawara |
Organization
MED MIRAI, Ink
Division name
Well-Being Division
Zip code
113-8656
Address
Entrepreneur Lab Utokyo South Clinical Research Bldg,.7-3-1 Hongo,Bunkyo-ku, Tokyo
TEL
090-9142-5745
Homepage URL
amed@medmirai.co.jp
Sponsor or person
Institute
MED MIRAI, Ink
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, School of Engineering, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8656
Tel
03-5841-1846
rinri@anzen.t.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
KE25-5
Org. issuing International ID_1
Research Ethics Committee, School of Engineering, The University of Tokyo
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 | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066137
