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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Metabolic Syndrome Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of three parallel groups: health information, functional clothing, or moderate exercise.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Due to the nature of the interventions, participants and investigators cannot be blinded.

Study Groups

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Health Information Group

Participants will receive an educational leaflet on lifestyle modification.

Group Type ACTIVE_COMPARATOR

Educational Leaflet

Intervention Type 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 Clothing Group

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

Group Type EXPERIMENTAL

Functional Shirt (Relive brand)

Intervention Type 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.

Moderate Exercise Group

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.

Group Type EXPERIMENTAL

Exercise Manual

Intervention Type 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.

Interventions

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Educational Leaflet

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.

Intervention Type BEHAVIORAL

Functional Shirt (Relive brand)

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.

Intervention Type DEVICE

Exercise Manual

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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