Clinical Trial

Feasibility Trial of Functional Clothing, Moderate Exercise, and Health Information for Stress Reduction and Behavior Change in Okinawa

Study acronym: Y-RELIVE
Completed
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Summary
This study is a pilot randomized trial conducted in Yomitan Village, Okinawa, Japan. The purpose is to evaluate whether three simple, low-cost interventions can help reduce stress and support healthy behavior change in community-dwelling adults. The interventions are: (1) providing health information through educational leaflets, (2) wearing functional clothing designed to support physical comfort, and (3) practicing moderate exercise using a simple manual. A total of 45 adults, aged 20 to 59 years, with overweight or pre-metabolic syndrome will be recruited. Participants will be assigned randomly into one of the three groups. The study duration is eight weeks. Outcomes include fatigue scores, mood states, sleep quality, and heart rate variability measured by a smart ring. Data will be collected at baseline and after eight weeks of intervention. This study aims to test whether these approaches are feasible, safe, and acceptable for residents. The results will help design larger studies in the future and provide evidence for community-based prevention programs that are easy to adopt in daily life.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-24.
Status change: Not Yet Recruiting → Completed 2026-05-20
Trial Details
NCT Number NCT07204483
Lead Sponsor Shinyu Kise
Collaborators: Relive Co., Ltd., Yomitan Village Health Promotion Division
Conditions Obesity, Metabolic Syndrome, Stress, Psychological
Enrollment 45 participants
Start Date 2025-10-16
Primary Completion 2026-03-26 (estimated)
Study Completion 2026-03-26 (estimated)
Updated on ClinicalTrials.gov 2026-08-10