Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans
|ClinicalTrials.gov Identifier: NCT00783445|
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: Community-Based Exercise Program (C-FIT) Behavioral: Self-Help Exercise Program (HOME)||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community Exercise and Metabolic Syndrome in Black Families|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Exercise in a community setting while supervised by a coach
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.
Active Comparator: 2
Self-exercise plan based on an individualized prescription after an initial fitness evaluation
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.
- 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 ]
- habitual physical activity score using a standardized questionnaire [ Time Frame: 6 months, 1 year, 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783445
|United States, Maryland|
|Johns Hopkins Bayview Institute for Clinical Translational Research|
|Baltimore, Maryland, United States, 21287|