Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans

Tracking Information
First Submitted Date ICMJE	October 30, 2008
First Posted Date ICMJE	October 31, 2008
Last Update Posted Date	March 11, 2014
Study Start Date ICMJE	December 2008
Actual Primary Completion Date	April 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 30, 2008)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00783445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 10, 2009)	habitual physical activity score using a standardized questionnaire [ Time Frame: 6 months, 1 year, 2 years ]
Original Secondary Outcome Measures ICMJE; (submitted: October 30, 2008)	Improvement in endothelial function, as measured by brachial artery flow mediated dilatation [ Time Frame: Measured at baseline and Years 1 and 2 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans
Official Title ICMJE	Community Exercise and Metabolic Syndrome in Black Families
Brief 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. 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 Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Metabolic Syndrome
Intervention ICMJE	Behavioral: 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.; Behavioral: 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.
Study Arms	Experimental: 1 Exercise in a community setting while supervised by a coach Intervention: Behavioral: Community-Based Exercise Program (C-FIT); Active Comparator: 2 Self-exercise plan based on an individualized prescription after an initial fitness evaluation Intervention: Behavioral: Self-Help Exercise Program (HOME)
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.; Brown 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 10, 2014)	204
Original Estimated Enrollment ICMJE; (submitted: October 30, 2008)	200
Actual Study Completion Date	April 2013
Actual Primary Completion Date	April 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Participating in the Johns Hopkins Sibling and Family Heart Studies; Has metabolic syndrome components; Self-identifies as Black American Exclusion Criteria: 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); 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
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00783445
Other Study ID Numbers ICMJE	610; R01HL089474-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr. Diane Becker, Johns Hopkins University
Study Sponsor ICMJE	Johns Hopkins University
Collaborators ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Investigators ICMJE	Not Provided
PRS Account	Johns Hopkins University
Verification Date	March 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP