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临床试验/NCT00943254
NCT00943254已完成不适用

Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
74
试验地点
2
主要终点
Lifestyle Change: Readiness to Exercise, level of physical activity

研究概览

简要总结

This study is being done to gain knowledge on how effective different approaches of providing a diagnosis and varying educational tools that include DVDs and multimedia or printed instruction sheets on your readiness to increase the subject's level of exercise, lose more weight, eat a healthier diet; and to assess the subject's awareness of their risk of heart disease and their readiness to participate in a comprehensive lifestyle modification program.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any 3 of the following 5:
  • History of hypertension or either systolic blood pressure >125 or diastolic blood pressure >85 mmHg or documented history and receiving treatment for it
  • Abdominal circumference ≥40 inches in men or ≥35 inches in women
  • Fasting triglycerides ≥ 150mg/dL or receiving treatment for it
  • Fasting blood glucose ≥ 100mg/dL but <126mg/dL
  • HDL cholesterol <40mg/dL in men or <50mg/dL in women or receiving treatment for it

排除标准

  • Documented diagnosis of metabolic syndrome in the clinical record, if previously seen at Mayo.
  • History of coronary artery disease
  • Diabetes mellitus, or using an oral hypoglycemic pill for glucose intolerance
  • Congestive heart failure
  • Familial hypercholesterolemia including familial hypertriglyceridemia,
  • Fasting LDL-cholesterol >160 mg/dL
  • Fasting triglycerides > 390 mg/dL
  • Have systolic blood pressure >160 and diastolic blood pressure >100mg/dL
  • History of hypertension with changes in their blood pressure medicines within the last 60 days before enrollment.
  • History of dyslipidemia and changes on their lipid lowering agents such as statins, ezetimibe, fibrates or niacin within the last 60 days before enrollment.
  • Secondary causes of obesity such as hypothyroidism, Cushing syndrome, or eating disorders
  • Pregnant women or women planning to get pregnant during the duration of the study
  • Advanced liver disease
  • Renal insufficiency
  • Having any other major chronic medical condition
  • Unable to do their basic chores at home due to musculoskeletal limitations or other factors affecting their functional status.
  • Physical activity of more than 60 minutes per week of moderate to intense exercise

结局指标

主要结局

Lifestyle Change: Readiness to Exercise, level of physical activity

时间窗: 6 weeks

Stages of Change for Exercise and for Fruits and vegetables

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

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Metabolic Syndrome Diagnosis and Education Trial | 临床试验