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

Not Applicable

Not yet recruiting

• Conditions: Obesity; Metabolic Syndrome; Stress, Psychological

• Registration Number: NCT07204483
• Lead Sponsor: Shinyu Kise

Brief 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 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.

Detailed Description

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study Start: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-01-04
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Adults aged 20 to 65 years, residing in Yomitan Village
• Body Mass Index (BMI) ≥25, or judged as pre-metabolic syndrome by a physician
• Owns a smartphone and able to use the study application

Exclusion Criteria

• Severe cardiovascular disease or psychiatric illness
• Medical contraindication to moderate exercise
• Unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue Score (Visual Analog Scale, 0-100 mm)	Baseline and Week 8	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.
Total Mood Disturbance (Profile of Mood States-2)	Baseline and Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Sleep Duration (hours/night)	Baseline and Week 8	Average nightly sleep duration measured objectively using a smart ring.
Sleep Efficiency (%)	Baseline and Week 8	Percentage of time in bed spent asleep, measured objectively using a smart ring.
Heart Rate Variability (HRV)	Baseline and Week 8	Autonomic function assessed via smart ring-derived HRV indicators, including SDNN and RMSSD.
Adherence Rate	Throughout 8-week intervention	Percentage of participants completing prescribed intervention activities (leaflet reading, shirt wearing, or exercise sessions).
Adverse Events	Throughout 8-week intervention	Frequency and type of adverse events, including skin irritation and muscle soreness, monitored continuously.

Trial Locations

Locations (1)

Ryusei Hospital; 🇯🇵 Naha, Okinawa, Japan