Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Lifestyle Change: Readiness to Exercise, level of physical activity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Arm 1
Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials
Intervention: High-Tech Education (Other)
Arm 2
Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material
Intervention: Low-Tech Education (Other)
Arm 3
Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material
Outcomes
Primary Outcomes
Lifestyle Change: Readiness to Exercise, level of physical activity
Time Frame: 6 weeks
Stages of Change for Exercise and for Fruits and vegetables
Time Frame: 6 weeks
Secondary Outcomes
No secondary outcomes reported