Tokyo, Jan. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060384) titled 'Effectiveness of a health tourism program in reducing salt intake' on Jan. 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kanazawa University
Condition:
Condition - Hypertension or elevated blood pressure
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
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 Size - 30
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069069
Disclaimer: Curated by HT Syndication.
