Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2007-10-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Arm 1
Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials
High-Tech Education
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
Arm 2
Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material
Low-Tech Education
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.
Arm 3
Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material
No interventions assigned to this group
Interventions
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High-Tech Education
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
Low-Tech Education
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.
Eligibility Criteria
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Inclusion Criteria
1. History of hypertension or either systolic blood pressure \>125 or diastolic blood pressure \>85 mmHg or documented history and receiving treatment for it
2. Abdominal circumference ≥40 inches in men or ≥35 inches in women
3. Fasting triglycerides ≥ 150mg/dL or receiving treatment for it
4. Fasting blood glucose ≥ 100mg/dL but \<126mg/dL
5. HDL cholesterol \<40mg/dL in men or \<50mg/dL in women or receiving treatment for it
Exclusion Criteria
2. History of coronary artery disease
3. Diabetes mellitus, or using an oral hypoglycemic pill for glucose intolerance
4. Congestive heart failure
5. Familial hypercholesterolemia including familial hypertriglyceridemia,
6. Fasting LDL-cholesterol \>160 mg/dL
7. Fasting triglycerides \> 390 mg/dL
8. Have systolic blood pressure \>160 and diastolic blood pressure \>100mg/dL
9. History of hypertension with changes in their blood pressure medicines within the last 60 days before enrollment.
10. History of dyslipidemia and changes on their lipid lowering agents such as statins, ezetimibe, fibrates or niacin within the last 60 days before enrollment.
11. Secondary causes of obesity such as hypothyroidism, Cushing syndrome, or eating disorders
12. Pregnant women or women planning to get pregnant during the duration of the study
13. Advanced liver disease
14. Renal insufficiency
15. Having any other major chronic medical condition
16. Unable to do their basic chores at home due to musculoskeletal limitations or other factors affecting their functional status.
17. Physical activity of more than 60 minutes per week of moderate to intense exercise
18 Years
80 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic- Rohester
Principal Investigators
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Randal J Thomas, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Jumean MF, Korenfeld Y, Somers VK, Vickers KS, Thomas RJ, Lopez-Jimenez F. Impact of diagnosing metabolic syndrome on risk perception. Am J Health Behav. 2012 Jul;36(4):522-32. doi: 10.5993/AJHB.36.4.9.
Other Identifiers
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07-006106
Identifier Type: -
Identifier Source: org_study_id