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

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 Overview

• Status: Completed
• Conditions: Metabolic Cardiovascular Syndrome
• Intervention / Treatment: Other: High-Tech Education; Other: Low-Tech Education

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials	Other: 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
Experimental: Arm 2; Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material	Other: 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.
No Intervention: Arm 3; Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Randal J Thomas, MD, MS, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 20, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Estimate): October 15, 2010
• Last Update Submitted That Met QC Criteria: October 13, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Metabolic Cardiovascular Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 07-006106