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临床试验/NCT05472298
NCT05472298已完成不适用

The Effectiveness of Self-Management Skills and Technology in Individuals Who Have Both Metabolic Syndrome in Community

Chang Gung University of Science and Technology1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
1
主要终点
metabolic syndrome

研究概览

简要总结

The multidimensional self-management intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome. Thus, the purpose of this study was to assess the efficacy of multidimensional self-management 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 each follow visit (6th months and 18th months). All participants complete a structured questionnaire, including basic information, 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
50 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • adult women with age ≥ 50 years
  • low education, defined as having less than 6 years of education or being primary school graduates
  • presence of metabolic syndrome
  • 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: 6 month, and 18-month follow up

changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference

次要结局

  • BMI(6 months, and 18 months follow up)
  • body weight(6 months, and 18 months follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shu-Hung Chang

Professor

Chang Gung University of Science and Technology

研究点 (1)

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