UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061533 |
|---|---|
| Receipt number | R000069672 |
| Scientific Title | Effective Implementation of The Evidence-Based Specific Health Guidance |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/05/12 09:11:02 |
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Basic information
Public title
Effective Implementation of The Evidence-Based Specific Health Guidance
Acronym
A study for The Evidence-Based Specific Health Guidance
Scientific Title
Effective Implementation of The Evidence-Based Specific Health Guidance
Scientific Title:Acronym
A study for The Evidence-Based Specific Health Guidance
Region
| Japan |
Condition
Condition
Lifestyle-related diseases
Classification by specialty
| Medicine in general | Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evidence-based development of an integrated health guidance program (Well Smart) utilizing ICT and tailored for individuals in their 40s, integrating multidimensional big data analysis and qualitative research, and its effectiveness verification through an open-label two-group comparative intervention trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight change: Compare the difference in mean change in weight between the assigned groups at baseline before the intervention and at the end of the program (3 months).
Key secondary outcomes
Waist circumference, blood pressure, lipids, blood glucose, urine sodium-to-potassium ratio: Compare the difference in mean change between treatment groups for secondary outcomes at baseline and 3 months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Device,equipment | Behavior,custom | Maneuver |
| Other |
Interventions/Control_1
The intervention group will receive a three-month health guidance program using ICT, along with questionnaire surveys and measurements of weight, waist circumference, and urinary natriuretic peptide ratio at baseline, midpoint, and completion. Blood samples will also be collected at baseline and completion.
Interventions/Control_2
The control group will not receive the program. Questionnaires, weight measurements, waist circumference measurements, urine natriuretic peptide ratio measurements, and blood draws will be conducted twice: before the intervention begins and after it ends.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Employees who are 40 years of age or older and 65 years of age or younger at the time of obtaining consent.
2) Individuals capable of independently performing the operations and wearing the ICT devices required for the study.
3) BMI of 25 or higher
4) Individuals who, based on their health examination results, meet at least one of the following risk factors for metabolic syndrome:
Hypertension: Systolic blood pressure (maximum) of 130 mmHg or higher, or diastolic blood pressure (minimum) of 85
mmHg or higher, or taking antihypertensive medication
Dyslipidemia: Triglycerides of 150 mg/dL or higher, or HDL cholesterol below 40 mg/dL, or taking lipid-lowering medication
Hyperglycemia: Fasting blood glucose of 110 mg/dL or higher, or HbA1c of 6.0% or higher, or currently taking medication for diabetes
5) Individuals capable of undergoing and participating in physical measurements and fitness tests
6) Individuals who have provided informed consent to participate in the study
7) Individuals who have been approved to participate by their attending physician or other medical professional
Key exclusion criteria
Individuals who are pregnant or breastfeeding, those with severe liver or kidney dysfunction, and those who have been hospitalized or undergone surgery for an orthopedic condition within the past three months are excluded. In addition, individuals deemed unsuitable by the principal investigator or co-investigators will also be excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Rumi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Science Tokyo
Division name
Department of Public Health Nursing
Zip code
1138510
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8510 Japan
TEL
03-5803-5350
tsukinoki.r.9a12@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Rumi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Science Tokyo
Division name
Department of Public Health Nursing
Zip code
1138510
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8510 Japan
TEL
03-5803-5350
Homepage URL
https://www.tmd.ac.jp/chn/tokuteihokenshidou/
tsukinoki.r.9a12@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Human Subjects Research Ethics Review Committee
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8510 Japan
Tel
03-5803-4547
rinri.adm@tmd.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 | 05 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.tmd.ac.jp/chn/tokuteihokenshidou/
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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | 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
| 2026 | Year | 05 | Month | 12 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069672
