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

NCT07204483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-05-22

No results posted yet for this study

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 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.

Conditions

Interventions

BEHAVIORAL

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.

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Shinyu Kise

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-04
Completion
2026-04-01

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07204483 on ClinicalTrials.gov