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

NCT07204483 | Not Yet Recruiting

• 1 other identifier: YomitanRelive2025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome; Stress, Psychological

Keywords

Stress reduction; Behavior change; Functional clothing; Exercise; Sleep quality; Heart rate variability; Okinawa; Yomitan

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline and Week 8

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

  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.

  Baseline and Week 8

Secondary Outcomes (5)

• Sleep Duration (hours/night)

  Baseline and Week 8

• Sleep Efficiency (%)

  Baseline and Week 8

• Heart Rate Variability (HRV)

  Baseline and Week 8

• Adherence Rate

  Throughout 8-week intervention

• Adverse Events

  Throughout 8-week intervention

Study Arms (3)

Health Information Group

ACTIVE COMPARATOR

Participants will receive an educational leaflet on lifestyle modification.

Behavioral: Educational Leaflet

Functional Clothing Group

EXPERIMENTAL

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

Device: Functional Shirt (Relive brand)

Moderate Exercise Group

EXPERIMENTAL

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.

Behavioral: Exercise Manual

Interventions

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.

Health Information Group

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.

Functional Clothing Group

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.

Moderate Exercise Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shinyu Kise: lead

Study Sites (1)

Ryusei Hospital

Naha, Okinawa, 902-0066, Japan

Location

Related Publications (5)

• Dunton GF, Crosley-Lyons R, Rhodes RE. Affective Response During Real-World Physical Activity as an Intervention Mediator. Exerc Sport Sci Rev. 2023 Oct 1;51(4):140-149. doi: 10.1249/JES.0000000000000321. Epub 2023 May 17.

  PMID: 37195062 BACKGROUND

• Stevens CJ, Baldwin AS, Bryan AD, Conner M, Rhodes RE, Williams DM. Affective Determinants of Physical Activity: A Conceptual Framework and Narrative Review. Front Psychol. 2020 Dec 1;11:568331. doi: 10.3389/fpsyg.2020.568331. eCollection 2020.

  PMID: 33335497 BACKGROUND

• Dimsdale JE. Psychological stress and cardiovascular disease. J Am Coll Cardiol. 2008 Apr 1;51(13):1237-46. doi: 10.1016/j.jacc.2007.12.024.

  PMID: 18371552 BACKGROUND

• Chouchou F, Desseilles M. Heart rate variability: a tool to explore the sleeping brain? Front Neurosci. 2014 Dec 11;8:402. doi: 10.3389/fnins.2014.00402. eCollection 2014.

  PMID: 25565936 BACKGROUND

• Cohen S, Janicki-Deverts D, Miller GE. Psychological stress and disease. JAMA. 2007 Oct 10;298(14):1685-7. doi: 10.1001/jama.298.14.1685. No abstract available.

  PMID: 17925521 BACKGROUND

Related Links

• Institute for Health Tourism, Ryusei Hospital (project overview)

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Stress, Psychological; Motor Activity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Shinyu Kise, PhD

CONTACT

+81-98-885-5131; kise.ryusei@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the interventions, participants and investigators cannot be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Institute for Tourism and Health; Principal Investigator, Ryusei Hospital

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

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion: January 4, 2026
• Study Completion: February 28, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)