UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062652 |
|---|---|
| Receipt number | R000071717 |
| Scientific Title | A Study on the Feasibility of Implementing an ICT-Based Lifestyle Improvement Support System |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/21 18:17:11 |
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Basic information
Public title
A Study on the Usability and Ease of Implementation of an ICT-Based Lifestyle Improvement Support System for Specific Health Guidance
Acronym
ICT Lifestyle Support Study
Scientific Title
A Study on the Feasibility of Implementing an ICT-Based Lifestyle Improvement Support System
Scientific Title:Acronym
ICT Lifestyle Support Feasibility Study
Region
| Japan |
Condition
Condition
Individuals eligible for Specific Health Guidance
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an ICT-based lifestyle improvement support system combining LINE, e-learning materials, and a record form for Specific Health Guidance, and to assess the feasibility of its implementation.
Basic objectives2
Others
Basic objectives -Others
Feasibility of implementation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Utilization of the ICT-based lifestyle improvement support system
During the intervention period (approximately 3 months), utilization will be assessed based on the presence and frequency of LINE message exchanges, use of the record form, provision and viewing of e-learning materials, and continuation of system use.
2.Acceptability among participants
At the end of the intervention, acceptability will be assessed in terms of usability of the ICT-based lifestyle improvement support system, ease of receiving health guidance, satisfaction, intention to continue using the system, perceived burden, and suggestions for improvement.
3.Feasibility among healthcare providers
At the end of the intervention, feasibility among public health nurses and other healthcare providers will be assessed in terms of system usability, feasibility of implementation in routine practice, ease of providing support to participants, workload and psychological burden associated with reviewing records and responding to messages, operational challenges, and areas for improvement.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants eligible for Specific Health Guidance will receive health guidance using an ICT-based lifestyle improvement support system that combines a LINE official account, a record form using the Shimane electronic application service, and e-learning materials.
After enrollment, healthcare providers will explain the participants' health examination results, identify lifestyle-related issues, and set behavioral goals in accordance with the usual process of Specific Health Guidance. Participants will then register the LINE official account and begin continuous support.
The intervention period will be approximately 3 months. During this period, participants will enter information on their lifestyle practices, body weight, and achievement of behavioral goals into the record form as needed. Based on these records, health examination results, behavioral goals, and consultations, healthcare providers will provide lifestyle-related advice, encouragement, goal review, consultation, and information on relevant e-learning materials through LINE chat. The frequency of support will be individualized according to participants' needs and will not be fixed.
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals who reside in a municipality in Shimane Prefecture, are enrolled in the National Health Insurance system, and have been identified as eligible for Specific Health Guidance based on the results of a Specific Health Checkup.
2.Individuals aged 40 to 64 years at the time of informed consent.
3.Individuals who own a smartphone and are able to use the ICT-based lifestyle improvement support system.
4.Individuals who are able to understand explanations provided in Japanese and make an informed decision regarding participation in the study.
5.Individuals who provide written informed consent to participate in the study.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Taniguchi |
Organization
Shimane University
Division name
Department of Fundamental Nursing, School of Nursing, Faculty of Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853-20-2324
ktanigu@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Taniguchi |
Organization
Shimane University
Division name
Department of Fundamental Nursing, School of Nursing, Faculty of Medicine
Zip code
693-850
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853-20-2324
Homepage URL
ktanigu@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2026 | Year | 08 | Month | 21 | 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
| 2026 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071717
