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 65 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.
Lifestyle-related diseases, including obesity and metabolic syndrome, are major health concerns worldwide. Stress and insufficient physical activity are important risk factors. Developing simple and sustainable interventions that can be adopted in daily life is essential for effective prevention. This feasibility trial compares functional clothing, moderate exercise, and health information in a community setting. The results will provide insight into feasibility, adherence, and potential effectiveness, forming the basis for future large-scale randomized controlled trials and community health programs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
45
Participants will receive an educational leaflet on lifestyle modification, which provides practical advice on diet, physical activity, and stress management. The leaflet will be distributed at baseline.
Participants will receive a functional shirt designed to support posture and physical comfort (Relive brand). They will be instructed to wear the shirt daily during the 8-week intervention period. Manufacturer: Relive Inc., Japan.
Participants will receive a structured exercise manual and will be instructed to perform moderate-intensity exercise (e.g., brisk walking, light jogging, or calisthenics) for 30 minutes, three times per week, over 8 weeks. Weekly follow-up calls or messages will be provided to encourage adherence.
Ryusei Hospital
Naha, Okinawa, Japan
Fatigue Score (Visual Analog Scale, 0-100 mm)
Change in subjective fatigue measured using a 100-mm Visual Analog Scale (VAS). Scores range from 0 (no fatigue) to 100 (worst possible fatigue). Higher scores indicate worse fatigue.
Time frame: Baseline and Week 8
Total Mood Disturbance (Profile of Mood States-2)
Change in total mood disturbance score assessed using the Profile of Mood States-2 (POMS-2). Scores range from -32 to 200. Higher scores indicate worse mood.
Time frame: Baseline and Week 8
Sleep Duration (hours/night)
Average nightly sleep duration measured objectively using a smart ring.
Time frame: Baseline and Week 8
Sleep Efficiency (%)
Percentage of time in bed spent asleep, measured objectively using a smart ring.
Time frame: Baseline and Week 8
Heart Rate Variability (HRV)
Autonomic function assessed via smart ring-derived HRV indicators, including SDNN and RMSSD.
Time frame: Baseline and Week 8
Adherence Rate
Percentage of participants completing prescribed intervention activities (leaflet reading, shirt wearing, or exercise sessions).
Time frame: Throughout 8-week intervention
Adverse Events
Frequency and type of adverse events, including skin irritation and muscle soreness, monitored continuously.
Time frame: Throughout 8-week intervention
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