The Effectiveness of Technology Combined Self-health Management and Home Care Model Improved the Metabolic Diseases, Sarcopenia, and Serum Inflammation and Metabolic Markers Among Middle-aged and Elderly Individuals in the Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- metabolic syndrome
研究概览
简要总结
The lifestyle program intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome, sarcopenia or frailty. Thus, the purpose of this study was to assess the efficacy of intervention program on metabolic syndrome subjects in Taiwan.
详细描述
The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) >150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and 4th months. All participants complete a structured questionnaire, including basic information, SOF, physical performance, physical activity, and food-frequency.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •older adult with age ≥ 40 years
- •community-dwelling
- •no hearing and visual acuity difficulties
排除标准
- •Unconscious
- •Cognitive impairment or dementia
结局指标
主要结局
metabolic syndrome
时间窗: 4 month follow up
changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference
body weight
时间窗: 4 month follow up
weight in kilograms
BMI
时间窗: 4 month follow up
weight and height will be combined to report BMI in kg/m\^2
Frailty
时间窗: 4 month follow up
measurement used study of osteoporotic fracture index (SOF).
次要结局
- physical agility and dynamic balance ability(4 month follow up)
- short physical performance battery(4 month follow up)
- upper limb muscle strength(4 month follow up)
- static balance ability(4 month follow up)
研究者
Shu-Hung Chang
Professor
Chang Gung University of Science and Technology
