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Metabolic Syndrome Diagnosis and Education Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00943254
Enrollment
74
Registered
2009-07-22
Start date
2007-10-31
Completion date
2010-08-31
Last updated
2010-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Cardiovascular Syndrome

Keywords

Metabolic Cardiovascular Syndrome

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.

Interventions

OTHERHigh-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

OTHERLow-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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Lifestyle Change: Readiness to Exercise, level of physical activity6 weeks
Stages of Change for Exercise and for Fruits and vegetables6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026