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临床试验/NCT01912209
NCT01912209已完成不适用

Baptist Employee Healthy Heart Study (BEHHS) - A Novel Web-based Approach to Reduce Cardiovascular Disease Risk in a Diverse Employee Population With Metabolic Syndrome Via Diet and Lifestyle Change

Baptist Health South Florida2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2013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
发起方
入组人数
182
试验地点
2
主要终点
Reduction in BMI

研究概览

简要总结

The purpose of BEHHS is first to assess the baseline sub-clinical disease in a population of Baptist Health Employees who have Metabolic Syndrome, a known contributor to cardiovascular disease. Second, the investigators wish to encourage a healthy lifestyle through personalized nutrition and fitness advice, delivered as part of a web based program, which will in turn lead to increases in heart healthy behaviors such as increased consumption of heart healthy foods, increased exercise initiation, and more positive attitudes about health. To assess this, the investigators plan to randomize 200 employees with Metabolic Syndrome to either the new web-based diet and lifestyle program, or to care-as-usual, which is the currently offered MyWellnessAdvantage and WebMD websites. The investigators hypothesize that the web-based group will show greater improvements in physical health (such as weight loss, cholesterol reduction, etc.) as well as increased consumption of heart healthy foods, exercise initiation, and quality of sleep as measured by surveys administered at the 4,8, and 12 month follow-up appointments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Employee of Baptist Health
  • Access to Internet
  • Has a smart phone (Android or Apple supported) with data plan
  • Has an email address
  • Diagnosis of three or more of the following:
  • Waist circumference >=40 inches in and male and >= 35 inches in a female
  • Fasting triglyceride level > 150 mg/dl*
  • HDL-C < 40 mg/dl in men or < 50 mg/dl in women*
  • BP > 130/85 mm Hg*
  • Fasting blood glucose > 110 mg/dl
  • Or currently on medication to treat the abnormal condition

排除标准

  • Prior history of major cardiovascular events (angina, myocardial infarction, prior coronary revascularization
  • Any woman of childbearing potential who is pregnant, breastfeeding/currently lactating, seeking to become pregnant or suspects that she may be pregnant**
  • Active treatment for cancer
  • Known history of a bilateral mastectomy
  • Known history of diabetes (already being treated as high-risk group, would not qualify as having Metabolic Syndrome for purposes of our study)
  • Known history of Chronic Obstructive Pulmonary Disease
  • Currently in atrial fibrillation
  • Known history of hypo-tension
  • Known history of heart failure
  • Known history of aortic valve stenosis
  • Known history of heart block
  • Chest CT scan in the last year
  • Cognitive inability as judged by the interviewer

结局指标

主要结局

Reduction in BMI

时间窗: 4 months, 12 months

次要结局

  • Change in Blood Pressure(4 months, 12 months)
  • Change in Glucose Regulation(4 months, 12 months)
  • Lifestyle Change(4 months, 12 months)
  • Change in Sub-Clinical Disease(12 months)
  • Change in waist circumference(4 months, 12 months)
  • Change in Lipids(4 months, 12 months)

研究者

发起方
Baptist Health South Florida
申办方类型
Other
责任方
Sponsor

研究点 (2)

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