Feasibility Trial of Functional Clothing, Moderate Exercise, and Health Information for Stress Reduction and Behavior Change in Okinawa (Y-RELIVE)

Shinyu Kise

Status: Not yet enrolling

Conditions: Obesity; Stress, Psychological; Metabolic Syndrome

Treatments: Behavioral: Exercise Manual; Device: Functional Shirt (Relive brand); Behavioral: Educational Leaflet

Study type: Interventional

Funder types: Other

Identifiers

NCT07204483

YomitanRelive2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 3 patient groups

Health Information Group

Active Comparator group

Description:

Participants will receive an educational leaflet on lifestyle modification.

Treatment:

Behavioral: Educational Leaflet

Functional Clothing Group

Experimental group

Description:

Participants will receive a functional shirt (Relive brand) and will be asked to wear it daily during the 8-week intervention.

Treatment:

Device: Functional Shirt (Relive brand)

Moderate Exercise Group

Experimental group

Description:

Participants will receive a structured exercise manual and will be instructed to perform moderate-intensity exercise for 30 minutes, three times per week, for 8 weeks.

Treatment:

Behavioral: Exercise Manual