UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060384 |
|---|---|
| Receipt number | R000069069 |
| Scientific Title | Effectiveness of a health tourism program in reducing salt intake |
| Date of disclosure of the study information | 2026/01/16 |
| Last modified on | 2026/01/16 18:31:45 |
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Basic information
Public title
Effectiveness of a health tourism program in reducing salt intake
Acronym
Health tourism program in reducing salt intake
Scientific Title
Effectiveness of a health tourism program in reducing salt intake
Scientific Title:Acronym
Health tourism program in reducing salt intake
Region
| Japan |
Condition
Condition
Hypertension or elevated blood pressure
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in blood pressure, salt intake, and stress indices following participation in a spa-based health tourism program, using questionnaires, urinalysis, and wearable devices, and to exploratively elucidate the mechanisms contributing to blood pressure reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in salt check sheet score at 4 weeks
Key secondary outcomes
Changes from baseline in urinary parameters (estimated salt intake and urinary Na/K ratio)
Changes from baseline in systolic and diastolic blood pressure
Changes from baseline in the mean scores of the POMS2 Short Form (Total Mood Disturbance [TMD] and subscales: Anger-Hostility [AH], Confusion-Bewilderment [CB], Depression-Dejection [DD], Fatigue-Inertia [FI], Tension-Anxiety [TA], Vigor-Activity [VA], and Friendliness [F])
Changes from baseline in the total score and mean scores of the four individual items of the Subjective Happiness Scale (SHS) Japanese version
Time-course changes in parameters measured by wearable devices
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Monitoring and recording of health status
2. Health promotion via hot springs supervised by safety guides
3. Dietary experiences using local ingredients, focusing on salt reduction, weight loss, and high potassium intake
4. Light physical activity through local sightseeing
5. Mindfulness sessions
6. Provision of a high-quality sleep environment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Aged 18 years or older
2. Any gender
3. Willing participants with a history of hypertension or current blood pressure equal or more than 130/80 mmHg
Key exclusion criteria
1. Individuals deemed by the principal investigator or co-investigators to be unable to complete study procedures (questionnaires, urinalysis, or smartband usage)
2. Individuals unable or unwilling to provide informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
Frontier Institute of Tourism Sciences
Zip code
9201192
Address
Kakuma-machi, Kanazawa, Ishikawa
TEL
0762645920
anomura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
Division of Convergence Science
Zip code
9201192
Address
Kakuma-machi, Kanazawa, Ishikawa
TEL
0762645920
Homepage URL
anomura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office, government of Japan
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 Ethics Committee of Kanazawa University
Address
13-1 Takaramachi, Kanazawa, Ishikawa
Tel
0762652110
rinri@adm.kanazawa-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 | 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
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 | 11 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
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=R000069069
