Skip to main content
OpenTrials
Completed

NCT Number: NCT07204483

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Behavior Behavioral Symptoms Body Weight Dyssomnias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Motor Activity Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress, Psychological

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ryusei Hospital

Naha, Okinawa, 902-0066, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational leaflet

Behavioral

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.

Functional Shirt (Relive brand)

Device

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.

Exercise Manual

Behavioral

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.

Primary outcomes

  1. Fatigue Score (Visual Analog Scale, 0-100 mm)

    Time frame: 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.

  2. Total Mood Disturbance (Profile of Mood States-2)

    Time frame: 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 outcomes

  1. Sleep Duration (hours/night)

    Time frame: Baseline and Week 8

    Average nightly sleep duration measured objectively using a smart ring.

  2. Sleep Efficiency (%)

    Time frame: Baseline and Week 8

    Percentage of time in bed spent asleep, measured objectively using a smart ring.

  3. Heart Rate Variability (HRV)

    Time frame: Baseline and Week 8

    Autonomic function assessed via smart ring-derived HRV indicators, including SDNN and RMSSD.

  4. Adherence Rate

    Time frame: Throughout 8-week intervention

    Percentage of participants completing prescribed intervention activities (leaflet reading, shirt wearing, or exercise sessions).

  5. Adverse Events

    Time frame: Throughout 8-week intervention

    Frequency and type of adverse events, including skin irritation and muscle soreness, monitored continuously.

Sponsors and collaborators

Lead sponsor

Shinyu Kise

Other

Registry information

Official study title

Community-Based Feasibility Trial Comparing Functional Clothing, Moderate Exercise, and Health Information for Stress Reduction and Behavior Change in Adults in Yomitan Village, Okinawa, Japan

Acronym: Y-RELIVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.