Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Community-Based Exercise Program (C-FIT); Self-Help Exercise Program (HOME)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic Cardiovascular Syndrome; Metabolic Syndrome; Obesity; Hyperglycemia