RiSE to Prevent Cardiovascular Disease in African Americans
Condition: Atherosclerosis; Stress; Hypertension; Dyslipidemias; Obesity; Diabetes; Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Atherosclerosis; Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate an innovative 8-wk stress reduction program
      called Resilience, Stress and Ethnicity (RiSE) program designed to reduce chronic stress
      associated with perceived discrimination among African Americans. African Americans residing
      in the Maywood community between the ages of 25 and 75 with at least one cardiovascular
      disease risk factor such as being overweight, having high blood pressure, or diabetes will be
      enrolled. The following specific aims will be addressed:

      Aim 1: Determine the feasibility and acceptability of the program as a strategy to reduce
      chronic stress in African Americans within the Maywood and surrounding community.

      Aim 2: Examine the extent to which training in RiSE (1) improves psychological well being,
      (2) decreases inflammatory burden, and (3) reduces cardiovascular risk in African Americans

      Participants will be randomized to either the RiSE program or the control (no intervention
      group). Participants will provide blood and saliva samples as well as complete written
      questionnaires asking them questions about their health, well-being, and early life at the
      start of the study, half way through the study (at 4 weeks), at the completion of the
      intervention (8 weeks) and 3 months after the completion of the intervention).
    

Detailed description: 
      The purpose of this study is to examine an 8-week stress reduction program for African
      Americans. The aim of this study is to determine the effectiveness of this stress reduction
      program in improving well-being and reducing risk for heart disease and stroke in African
      Americans.

      No drugs are involved with this study. Participants will be randomized (randomly selected) to
      either participate in an 8 -week stress reduction program or a control group (no stress
      reduction program). The stress reduction program entails attending a 2- hour small group
      class once a week for 8 consecutive weeks at Loyola University in Maywood. Classes will be
      offered in the evening and will focus on teaching effective strategies for coping with daily
      stress, particularly stress associated with being an African American.

      Blood and saliva samples will be collected at the beginning of the study, in the middle of
      the program (4 weeks), at the end of the program (8 weeks) and 3 months after the program
      ends. Blood samples will be analyzed for cholesterol levels, hemoglobin A1c (a measure that
      reflects blood sugar over time), and cytokines (which reflect inflammation in the body).
      Saliva samples will be assessed for a hormone called cortisol..

      Participants will also complete several written questionnaires to gather information about
      their stress, social status, perceive discrimination, mood, diet and exercise. Participants
      will be paid $25 for each of the three data collection time points ($75 total). Those
      participants who are randomized to attend the stress reduction classes will also be provided
      $15 for each class that they attend (8 X $15 = $120) to help cover travel expenses.
    

Intervention name(s): Resilience, Stress, and Ethnicity (RiSE)
Intervention type(s): Behavioral
Intervention description(s): Group based stress reduction program focused on helping minorities develop coping and empowerment skills
Other intervention name(s): RiSE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention