Clinical trial NCT00943254: Metabolic Syndrome Diagnosis and Education Trial
Official title: Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Cardiovascular Syndrome
Keywords: Metabolic Cardiovascular Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Any 3 of the following 5:

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:

1. Documented diagnosis of metabolic syndrome in the clinical record, if previously seen at Mayo.
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

Primary outcomes:
measure: Lifestyle Change: Readiness to Exercise, level of physical activity
timeFrame: 6 weeks
measure: Stages of Change for Exercise and for Fruits and vegetables
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Randal J Thomas, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.