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ObesityY-RELIVENCT07204483

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

A study testing Educational Leaflet, Functional Shirt (Relive brand) and Exercise Manual in people with Obesity and Metabolic Syndrome, run by Shinyu Kise at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Metabolic Syndrome, Stress, Psychological
What is being tested?
Educational Leaflet, Functional Shirt (Relive brand) and Exercise Manual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteJapan
Study dates
16 Oct 2025to 26 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adults aged 20 to 59 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Yomitan Village

    Yomitan, Okinawa, 904-0392

Other trials in Japan

About this study

Official 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

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.

Read the detailed 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.

Being tested
Educational Leaflet, Functional Shirt (Relive brand), Exercise Manual
Keywords
Stress reduction, Behavior change, Functional clothing, Exercise, Sleep quality, Heart rate variability, Okinawa, Yomitan
Medical subject headings
Obesity, Metabolic Syndrome, Stress, Psychological, Motor Activity, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational LeafletBehavioural

    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 Co., Ltd., Japan.

  • Exercise ManualBehavioural

    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.

Study groups in NCT07204483
Study groupRoleWhat they receive
Health Information GroupActive comparatorParticipants will receive an educational leaflet on lifestyle modification.
Receives: Behavioral: Educational Leaflet
Functional Clothing GroupExperimentalParticipants will receive a functional shirt (Relive brand) and will be asked to wear it daily during the 8-week intervention.
Receives: Device: Functional Shirt (Relive brand)
Moderate Exercise GroupExperimentalParticipants 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.
Receives: Behavioral: Exercise Manual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 8

  2. 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.

    Measured: Baseline and Week 8

Secondary outcomes (5)

  1. Sleep Duration (hours/night)

    Average nightly sleep duration measured objectively using a smart ring.

    Measured: Baseline and Week 8

  2. Sleep Efficiency (%)

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

    Measured: Baseline and Week 8

  3. Heart Rate Variability (HRV)

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

    Measured: Baseline and Week 8

  4. Adherence Rate

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

    Measured: Throughout 8-week intervention

  5. Adverse Events

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

    Measured: Throughout 8-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start16 Oct 2025
  3. Primary completion26 Mar 2026
  4. Study completion26 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of three parallel groups: health information, functional clothing, or moderate exercise.
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07204483
Sponsor's protocol ID
YomitanRelive2025
Acronym
Y-RELIVE
Status last verified
Aug 2026
First submitted
16 Sep 2025
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37195062

  • 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.

    PubMed 33335497

  • 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.

    PubMed 18371552

  • 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.

    PubMed 25565936

  • 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.

    PubMed 17925521

Questions about this trial

What is this clinical trial studying?

A study testing Educational Leaflet, Functional Shirt (Relive brand) and Exercise Manual in people with Obesity and Metabolic Syndrome, run by Shinyu Kise at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue Score (Visual Analog Scale, 0-100 mm) (time frame: Baseline and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07204483, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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