Metabolic Syndrome Diagnosis and Education Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolic Cardiovascular Syndrome

Intervention / Treatment
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* Other: High-Tech Education
* Other: Low-Tech Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients randomized to this arm receive the diagnosis of metabolic syndrome and subsequent education using paper-based and DVD materials | Other: High-Tech Education<br>* Patients will be told that they have the metabolic syndrome and will subsequently watch two 10-minute videos on the metabolic syndrome and on getting started with exercise. They also receive all the paper-based educational material as in arm 2<br>|
| Experimental: Arm 2<br>Patients in this arm receive the diagnosis of metabolic syndrome and subsequent education using paper-based material | Other: Low-Tech Education<br>* Patients will be told that they have the metabolic syndrome and will subsequently receive paper-based educational material on the metabolic syndrome,pre-diabetes, and hypertension. They also receive pamphlets on dietary management of high cholesterol and triglycerides, and the importance of exercise and weight loss.<br>|
| No Intervention: Arm 3<br>Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle Change: Readiness to Exercise, level of physical activity |  | 6 weeks | 
| Stages of Change for Exercise and for Fruits and vegetables |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Cardiovascular Syndrome