UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059026 |
|---|---|
| Receipt number | R000067506 |
| Scientific Title | Effectiveness of Digital Health Services in Preventing Lifestyle-Related Diseases |
| Date of disclosure of the study information | 2025/09/08 |
| Last modified on | 2025/09/07 21:54:29 |
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Basic information
Public title
Effectiveness of Digital Health Services in Preventing Lifestyle-Related Diseases
Acronym
Preventive Effect of Digital Technology on Lifestyle-Related Diseases
Scientific Title
Effectiveness of Digital Health Services in Preventing Lifestyle-Related Diseases
Scientific Title:Acronym
Preventive Effect of Digital Technology on Lifestyle-Related Diseases
Region
| Japan |
Condition
Condition
Non-communicable diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of digital health services in preventing lifestyle-related diseases by using digital devices such as smartwatches and smartphone apps.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, waist circumference, and blood pressure at 3 months.
Key secondary outcomes
1-Year Outcomes: Body Weight, Waist Circumference, Blood Glucose, HbA1c, Blood Pressure, and Initiation of Treatment for Diabetes and Hypertension.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
AI feedback is delivered daily via the smartphone app.
Interventions/Control_2
AI feedback is delivered weekly via the smartphone app.
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible participants shall be individuals who have provided consent, selected from among those targeted by the "Specific Health Guidance (Active Support and Motivational Support)" and the "Disease Severity Prevention Program," which are implemented by municipalities within the LIFE Study participating regions.
Key exclusion criteria
For Participants in the "Specific Health Guidance" Program:
Individuals already receiving medication for lifestyle-related diseases (diabetes, hypertension, or dyslipidemia) are not eligible for inclusion. Furthermore, individuals aged 75 or older are also not considered eligible. No other exclusion criteria will be set for this group.
For Participants in the "Disease Severity Prevention Program":
Individuals aged 75 or older are an exclusion criterion due to feasibility concerns regarding the implementation of the intervention. However, it should be noted that individuals already receiving medication for lifestyle-related diseases (diabetes, hypertension, or dyslipidemia) will not be excluded.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Haruhisa |
| Middle name | |
| Last name | Fukuda |
Organization
Kyushu University
Division name
Graduate School of Medical Sociences
Zip code
812-8582
Address
Higashi-ku, Maidashi 3-1-1, Fukuoka
TEL
092-642-6960
fukuda.haruhisa.977@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruhisa |
| Middle name | |
| Last name | Fukuda |
Organization
Kyushu University
Division name
Graduate School of Medical Sociences
Zip code
812-8582
Address
Higashi-ku, Maidashi 3-1-1, Fukuoka
TEL
092-642-6960
Homepage URL
fukuda.haruhisa.977@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Haruhisa Fukuda
Funding Source
Organization
JST
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
Institutional Review Board for Clinical Research
Address
Higashi-ku, Maidashi 3-1-1, Fukuoka
Tel
092-642-5082
byskenkyu@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 | 09 | Month | 08 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | 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 | 09 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067506
