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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Information Group | Active Comparator | Participants will receive an educational leaflet on lifestyle modification. |
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| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Duration (hours/night) | Average nightly sleep duration measured objectively using a smart ring. | Baseline and Week 8 |
| Sleep Efficiency (%) | Percentage of time in bed spent asleep, measured objectively using a smart ring. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryusei Hospital | Naha | Okinawa | 902-0066 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37195062 | Background | 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. | |
| 33335497 | 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. |
| Label | URL |
|---|---|
| Institute for Health Tourism, Ryusei Hospital (project overview) | View source |
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Participants will be randomly assigned to one of three parallel groups: health information, functional clothing, or moderate exercise.
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Due to the nature of the interventions, participants and investigators cannot be blinded.
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| 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. |
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| 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. |
|
| Baseline and Week 8 |
| Heart Rate Variability (HRV) | Autonomic function assessed via smart ring-derived HRV indicators, including SDNN and RMSSD. | Baseline and Week 8 |
| Adherence Rate | Percentage of participants completing prescribed intervention activities (leaflet reading, shirt wearing, or exercise sessions). | Throughout 8-week intervention |
| Adverse Events | Frequency and type of adverse events, including skin irritation and muscle soreness, monitored continuously. | Throughout 8-week intervention |
| 18371552 | 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. |
| 25565936 | 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. |
| 17925521 | 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D013315 | Stress, Psychological |
| D009043 | Motor Activity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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