Metabolic Syndrome, Obesity, Stress, Psychological
Conditions
Keywords
Stress reduction, Behavior change, Functional clothing, Exercise, Sleep quality, Heart rate variability, Okinawa, Yomitan
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 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.
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.
Interventions
BEHAVIORALEducational 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.
DEVICEFunctional 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 Co., Ltd., Japan.
BEHAVIORALExercise 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
Shinyu Kise
Relive Co., Ltd.
Yomitan Village Health Promotion Division
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Due to the nature of the interventions, participants and investigators cannot be blinded.
Intervention model description
Participants will be randomly assigned to one of three parallel groups: health information, functional clothing, or moderate exercise.
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Severe cardiovascular disease or psychiatric illness * Medical contraindication to moderate exercise * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Score (Visual Analog Scale, 0-100 mm) | Baseline and Week 8 | 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. |
| Total Mood Disturbance (Profile of Mood States-2) | Baseline and Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Duration (hours/night) | Baseline and Week 8 | Average nightly sleep duration measured objectively using a smart ring. |
| Sleep Efficiency (%) | Baseline and Week 8 | Percentage of time in bed spent asleep, measured objectively using a smart ring. |
| Heart Rate Variability (HRV) | Baseline and Week 8 | Autonomic function assessed via smart ring-derived HRV indicators, including SDNN and RMSSD. |
| Adherence Rate | Throughout 8-week intervention | Percentage of participants completing prescribed intervention activities (leaflet reading, shirt wearing, or exercise sessions). |
| Adverse Events | Throughout 8-week intervention | Frequency and type of adverse events, including skin irritation and muscle soreness, monitored continuously. |
Countries
Japan
Outcome results
None listed