Metabolic Syndrome Diagnosis and Education Trial

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00943254
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 3
• Duration (Months): 34
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Cardiovascular Syndrome	Other: High-Tech Education; Other: Low-Tech Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Lifestyle Change: Readiness to Exercise, level of physical activity [6 weeks]

2. Stages of Change for Exercise and for Fruits and vegetables [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00943254
• Other Study ID Numbers: 07-006106
• First Posted: Jul 22, 2009
• Last Update Posted: Oct 15, 2010
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: Metabolic Cardiovascular Syndrome
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Oct 15, 2010