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OpenTrials
Completed

NCT Number: NCT00943254

Metabolic Syndrome Diagnosis and Education Trial

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Tech Education

Other

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

Low-Tech Education

Other

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 outcomes

  1. Lifestyle Change: Readiness to Exercise, level of physical activity

    Time frame: 6 weeks

  2. Stages of Change for Exercise and for Fruits and vegetables

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2009
Registry last updated
Oct 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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