Metabolic Cardiovascular SyndromeNCT00943254
Metabolic Syndrome Diagnosis and Education Trial
A study testing High-Tech Education and Low-Tech Education in people with Metabolic Cardiovascular Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Cardiovascular Syndrome
- What is being tested?
- High-Tech Education and Low-Tech Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Metabolic Cardiovascular Syndrome
- Being tested
- High-Tech Education, Low-Tech Education
- Keywords
- Metabolic Cardiovascular Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Tech EducationOther
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 EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials Receives: Other: High-Tech Education |
| Arm 2 | Experimental | Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material Receives: Other: Low-Tech Education |
| Arm 3 | No intervention | Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle Change: Readiness to Exercise, level of physical activity
Measured: 6 weeks
Stages of Change for Exercise and for Fruits and vegetables
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startOct 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Cardiovascular SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Randal J Thomas, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943254
- Sponsor's protocol ID
- 07-006106
- Status last verified
- Oct 2010
- First submitted
- 20 Jul 2009
- Last updated
- 15 Oct 2010
- Results posted
- No
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.
PubMed 22488402
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change
- ClinicalTrials.gov ID
- NCT00943254
- Acronym / sponsor ID
- 07-006106
- Conditions
- Metabolic Cardiovascular Syndrome
- Keywords
- Metabolic Cardiovascular Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: High-Tech EducationPatients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials |
| Arm 2 | Experimental | Other: Low-Tech EducationPatients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material |
| Arm 3 | No intervention | –Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Tech EducationPatients 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 | Other | Arm 1 |
| Low-Tech EducationPatients 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. | Other | Arm 2 |
Primary outcome
Lifestyle Change: Readiness to Exercise, level of physical activity
Time frame: 6 weeks
Stages of Change for Exercise and for Fruits and vegetables
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2010.
- Derived from this study: PubMed 22488402Jumean 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randal J Thomas, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Tech Education and Low-Tech Education in people with Metabolic Cardiovascular Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle Change: Readiness to Exercise, level of physical activity (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00943254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2010.