Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change
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
- 1
- 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
- 是
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
研究组 & 干预措施
Arm 1
Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials
干预措施: High-Tech Education (Other)
Arm 2
Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material
干预措施: Low-Tech Education (Other)
Arm 3
Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material
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