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
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Cardiovascular Syndrome focused on measuring Metabolic Cardiovascular Syndrome
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
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
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
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
Learn more about this trial
Metabolic Syndrome Diagnosis and Education Trial
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