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Metabolic Syndrome Diagnosis and Education Trial

Primary Purpose

Metabolic Cardiovascular Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High-Tech Education

Low-Tech Education

About this trial

This is an interventional prevention trial for Metabolic Cardiovascular Syndrome focused on measuring Metabolic Cardiovascular Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials

Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material

Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material

Outcomes

Primary Outcome Measures

Lifestyle Change: Readiness to Exercise, level of physical activity

Stages of Change for Exercise and for Fruits and vegetables

Secondary Outcome Measures

Full Information

NCT ID

NCT00943254

First Posted

July 20, 2009

Last Updated

October 13, 2010

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00943254

Brief Title

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

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Cardiovascular Syndrome

Keywords

Metabolic Cardiovascular Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material

Arm Title

Arm 3

Arm Type

No Intervention

Arm Description

Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material

Intervention Type

Other

Intervention Name(s)

High-Tech Education

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Low-Tech Education

Intervention Description

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.

Primary Outcome Measure Information:

Title

Lifestyle Change: Readiness to Exercise, level of physical activity

Time Frame

6 weeks

Title

Stages of Change for Exercise and for Fruits and vegetables

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Randal J Thomas, MD, MS

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22488402

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.

Results Reference

derived

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Metabolic Syndrome Diagnosis and Education Trial

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