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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Fatigue Score (Visual Analog Scale, 0-100 mm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the interventions, participants and investigators cannot be blinded.
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Severe cardiovascular disease or psychiatric illness
- •Medical contraindication to moderate exercise
- •Unable to provide informed consent
研究组 & 干预措施
Health Information Group
Participants will receive an educational leaflet on lifestyle modification.
干预措施: Educational Leaflet (Behavioral)
Functional Clothing Group
Participants will receive a functional shirt (Relive brand) and will be asked to wear it daily during the 8-week intervention.
干预措施: Functional Shirt (Relive brand) (Device)
Moderate Exercise Group
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.
干预措施: Exercise Manual (Behavioral)
结局指标
主要结局
Fatigue Score (Visual Analog Scale, 0-100 mm)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Shinyu Kise
Director, Institute for Tourism and Health; Principal Investigator, Ryusei Hospital
General Incorporated Foundation Ryukyuseimeisaiseikai, Ryusei Hospital.