Metabolic SyndromePhase 3NCT00783445
Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans
A Phase 3 study testing Community-Based Exercise Program (C-FIT) and Self-Help Exercise Program (HOME) in people with Metabolic Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial summary
Black Americans with a family history of early heart disease tend to have a group of risk factors that can contribute to heart disease. These risk factors, which include excess body weight, high blood pressure, and high cholesterol, are known collectively as metabolic syndrome. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Community-Based Exercise Program (C-FIT) and Self-Help Exercise Program (HOME)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Apr 2013
- Phase
- Phase 3
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participating in the Johns Hopkins Sibling and Family Heart Studies
- Has metabolic syndrome components
- Self-identifies as Black American
Who cannot join
- Any clinical CAD
- Diabetes
- Major co-morbidity that precludes exercise (e.g., stroke, AIDS, cancer, neurological disorder, serious emphysema or exercise asthma, disabling arthritis)
- Resting systolic blood pressure greater than or equal to 160 mm Hg, resting diastolic blood pressure greater than or equal to 100 mm Hg, or exercise peak blood pressure greater than or equal to 250/115 mm Hg
- Known ejection fraction less than 40%
- Already participating in regular exercise, defined as 90 minutes per week of activities of greater than 5 metabolic equivalents (METS)
Show all 13Show fewer
- Cardiac arrhythmias, including supraventricular tachycardia in the 5 years before study entry, any ventricular tachycardia, or greater than 4-beat runs of nonsustained premature ventricular contractions on baseline screening exercise testing
- Body mass index (BMI) greater than 45 kg/m2
- Alcohol or substance abuse in the 12 months before study entry
- A known abnormal exercise electrocardiogram and an abnormal thallium scan (double abnormal), a moderate to severe defect on thallium scan, or a coronary calcium score greater than 500 on a prior screening
- An abnormal exercise screening test supervised by a physician as part of this study
- Pregnant
- Current smokers if they have stated evidence of shortness of breath with normal exercises or a diagnosis of chronic obstructive pulmonary disease by their physician, as verified by medical records
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Institute for Clinical Translational Research
Baltimore, Maryland, 21287
About this study
Official title: Community Exercise and Metabolic Syndrome in Black Families
Black Americans with a family history of early heart disease tend to have a group of risk factors that can contribute to heart disease. These risk factors, which include excess body weight, high blood pressure, and high cholesterol, are known collectively as metabolic syndrome. This study will compare a community-based, coach-led exercise program to an individual, self-led home-based exercise program to determine which program is more effective at reducing the metabolic syndrome risk factors that can lead to heart disease.
Read the detailed description
Metabolic syndrome is a term that is used to describe a group of risk factors for coronary artery disease (CAD). The risk factors include abdominal obesity, insulin resistance, high cholesterol, and high blood pressure. People who live a sedentary lifestyle and do not get enough exercise are at risk of developing metabolic syndrome and CAD. Black Americans also have an increased risk of metabolic syndrome and CAD, particularly if they have a sibling younger than 60 years old who has premature CAD. Studies have shown that people who engage in regular, moderate intensity exercise can eliminate metabolic syndrome risk factors that can lead to CAD; however, many high-risk Black Americans do not take part in regular exercise. The purpose of this study is to compare a community-based, coach-led exercise program to an individual, self-led home-based exercise program to examine which program is more effective at reducing the metabolic syndrome risk factors that can lead to CAD in Black Americans.
This study will enroll Black Americans with metabolic syndrome who have a sibling with premature CAD. Participants will be randomly assigned (by individual) to either a community-based exercise program (C-FIT) or a self-help home-based exercise program (HOME). Participants in the C-FIT group will do 1 hour of exercise two to three times each week in a community setting and will be supervised by a personal coach or trainer for 1 year. Participants in the SELF group will undergo a fitness evaluation and will be instructed on how to exercise on their own. They also will be expected to do 1 hour of exercise two to three times each week for 1 year. Study visits will occur at baseline, Month 6, and Years 1 and 2. At all study visits, participants will undergo the following: a medical history review; physical examination; blood pressure measurements; blood collection; body measurements, including height, weight, and waist circumference; a treadmill stress test; a strength test; a dual-energy x-ray absorptiometry (DEXA) scan to measure body fat; an echocardiogram to examine the heart; a flow-mediated vasodilatation test for brachial reactivity to measure vascular function; and questionnaires on diet, exercise habits, and self-efficacy.
- Conditions
- Metabolic Syndrome
- Being tested
- Community-Based Exercise Program (C-FIT), Self-Help Exercise Program (HOME)
- Keywords
- Metabolic Cardiovascular Syndrome, Metabolic Syndrome, Obesity, Hyperglycemia
- Medical subject headings
- Metabolic Syndrome, Obesity, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Based Exercise Program (C-FIT)Behavioural
Participants will do 1 hour of exercise two to three times each week in a community setting for 1 year, while being supervised by a personal coach.
Self-Help Exercise Program (HOME)Behavioural
After a fitness evaluation, participants will be given an exercise prescription and recommendations for home-based, self-mediated progressive exercise. Participants will be expected to do 1 hour of exercise two to three times each week for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise in a community setting while supervised by a coach Receives: Behavioral: Community-Based Exercise Program (C-FIT) |
| 2 | Active comparator | Self-exercise plan based on an individualized prescription after an initial fitness evaluation Receives: Behavioral: Self-Help Exercise Program (HOME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal oxygen consumption (VO2 max)
Measured: Measured at baseline, Month 6, and Years 1 and 2
Reduction in components of the metabolic syndrome
Measured: Measured at baseline and Years 1 and 2
Secondary outcomes (1)
habitual physical activity score using a standardized questionnaire
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Dr. Diane Becker, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783445
- Sponsor's protocol ID
- 610
- Other IDs
- R01HL089474-01
- Status last verified
- Mar 2014
- First submitted
- 30 Oct 2008
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kral BG, Becker LC, Vaidya D, Yanek LR, Becker DM. Silent myocardial ischaemia and long-term coronary artery disease outcomes in apparently healthy people from families with early-onset ischaemic heart disease. Eur Heart J. 2011 Nov;32(22):2766-72. doi: 10.1093/eurheartj/ehr261. Epub 2011 Jul 23.
PubMed 21785111Brown RV, Kral BG, Yanek LR, Vaidya D, Nyquist PA, Levine DM, Moy TF, Becker LC, Becker DM. Ethnic-specific determinants of exercise capacity in a healthy high-risk population. Med Sci Sports Exerc. 2012 Jun;44(6):1150-6. doi: 10.1249/MSS.0b013e3182456990.
PubMed 22215178
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Exercise and Metabolic Syndrome in Black Families
- ClinicalTrials.gov ID
- NCT00783445
- Acronym / sponsor ID
- 610
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Cardiovascular Syndrome, Metabolic Syndrome, Obesity, Hyperglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 31 Oct 2008 (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.
Black Americans with a family history of early heart disease tend to have a group of risk factors that can contribute to heart disease. These risk factors, which include excess body weight, high blood pressure, and high cholesterol, are known collectively as metabolic syndrome. This study will compare a community-based, coach-led exercise program to an individual, self-led home-based exercise program to determine which program is more effective at reducing the metabolic syndrome risk factors that can lead to heart disease.
Detailed description
Metabolic syndrome is a term that is used to describe a group of risk factors for coronary artery disease (CAD). The risk factors include abdominal obesity, insulin resistance, high cholesterol, and high blood pressure. People who live a sedentary lifestyle and do not get enough exercise are at risk of developing metabolic syndrome and CAD. Black Americans also have an increased risk of metabolic syndrome and CAD, particularly if they have a sibling younger than 60 years old who has premature CAD. Studies have shown that people who engage in regular, moderate intensity exercise can eliminate metabolic syndrome risk factors that can lead to CAD; however, many high-risk Black Americans do not take part in regular exercise. The purpose of this study is to compare a community-based, coach-led exercise program to an individual, self-led home-based exercise program to examine which program is more effective at reducing the metabolic syndrome risk factors that can lead to CAD in Black Americans.
This study will enroll Black Americans with metabolic syndrome who have a sibling with premature CAD. Participants will be randomly assigned (by individual) to either a community-based exercise program (C-FIT) or a self-help home-based exercise program (HOME). Participants in the C-FIT group will do 1 hour of exercise two to three times each week in a community setting and will be supervised by a personal coach or trainer for 1 year. Participants in the SELF group will undergo a fitness evaluation and will be instructed on how to exercise on their own. They also will be expected to do 1 hour of exercise two to three times each week for 1 year. Study visits will occur at baseline, Month 6, and Years 1 and 2. At all study visits, participants will undergo the following: a medical history review; physical examination; blood pressure measurements; blood collection; body measurements, including height, weight, and waist circumference; a treadmill stress test; a strength test; a dual-energy x-ray absorptiometry (DEXA) scan to measure body fat; an echocardiogram to examine the heart; a flow-mediated vasodilatation test for brachial reactivity to measure vascular function; and questionnaires on diet, exercise habits, and self-efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Community-Based Exercise Program (C-FIT)Exercise in a community setting while supervised by a coach |
| 2 | Active comparator | Behavioral: Self-Help Exercise Program (HOME)Self-exercise plan based on an individualized prescription after an initial fitness evaluation |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participating in the Johns Hopkins Sibling and Family Heart Studies
- Has metabolic syndrome components
- Self-identifies as Black American
Key exclusion criteria (13 listed)
- Any clinical CAD
- Diabetes
- Major co-morbidity that precludes exercise (e.g., stroke, AIDS, cancer, neurological disorder, serious emphysema or exercise asthma, disabling arthritis)
- Resting systolic blood pressure greater than or equal to 160 mm Hg, resting diastolic blood pressure greater than or equal to 100 mm Hg, or exercise peak blood pressure greater than or equal to 250/115 mm Hg
- Known ejection fraction less than 40%
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 |
|---|---|---|
| Community-Based Exercise Program (C-FIT)Participants will do 1 hour of exercise two to three times each week in a community setting for 1 year, while being supervised by a personal coach. | Behavioural | 1 |
| Self-Help Exercise Program (HOME)After a fitness evaluation, participants will be given an exercise prescription and recommendations for home-based, self-mediated progressive exercise. Participants will be expected to do 1 hour of exercise two to three times each week for 1 year. | Behavioural | 2 |
Primary outcome
Change in maximal oxygen consumption (VO2 max)
Time frame: Measured at baseline, Month 6, and Years 1 and 2
Reduction in components of the metabolic syndrome
Time frame: Measured at baseline and Years 1 and 2
1 secondary outcome
habitual physical activity score using a standardized questionnaire
Time frame: 6 months, 1 year, 2 years
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 11 Mar 2014.
- Background: PubMed 21785111Kral BG, Becker LC, Vaidya D, Yanek LR, Becker DM. Silent myocardial ischaemia and long-term coronary artery disease outcomes in apparently healthy people from families with early-onset ischaemic heart disease. Eur Heart J. 2011 Nov;32(22):2766-72. doi: 10.1093/eurheartj/ehr261. Epub 2011 Jul 23.
- Results publication: PubMed 22215178Brown RV, Kral BG, Yanek LR, Vaidya D, Nyquist PA, Levine DM, Moy TF, Becker LC, Becker DM. Ethnic-specific determinants of exercise capacity in a healthy high-risk population. Med Sci Sports Exerc. 2012 Jun;44(6):1150-6. doi: 10.1249/MSS.0b013e3182456990.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Community-Based Exercise Program (C-FIT) and Self-Help Exercise Program (HOME) in people with Metabolic Syndrome, run by Johns Hopkins University 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 3 inclusion and 13 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 11 Mar 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in maximal oxygen consumption (VO2 max) (time frame: Measured at baseline, Month 6, and Years 1 and 2). 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 NCT00783445, which also lists 2 linked publications.
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 11 Mar 2014; AzTrials last refreshed its copy on 30 Oct 2026.