RiSE to Prevent Cardiovascular Disease in African Americans



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Cholesterol, Obesity Weight Loss, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:25 - 75
Updated:3/20/2019
Start Date:August 3, 2017
End Date:July 1, 2019
Contact:Stephanie Klonowski, MS
Email:sklonowski@luc.edu
Phone:708-216-3603

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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).

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.

Inclusion Criteria:

- African American

- Living in Maywood community or surrounding area

- Able to speak, read, write English

- Have at least one of the following:

- Body Mass Index (BMI) > 25 (overweight or obese)

- Total cholesterol > 240

- Diabetes mellitus

- Systolic blood pressure the same or greater than 120 mmHg or diagnosis of hypertension
and/or taking antihypertensive medication

- Atrial fibrillation

- Parental history of myocardial infarction (MI) (heart attack) prior to age 60

Exclusion Criteria:

- Current smoker (smoked in last month)

- History of myocardial infarction or ischemic heart disease

- Current cancer

- Active infection

- Major Immune-related disorder (lupus,MS)

- Substance abuse

- Immune-altering drugs

- Recent dental procedure (within past 72 hours

- Bleeding gums or periodontal disease
We found this trial at
1
site
Maywood, Illinois 60153
Phone: 708-216-3603
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mi
from
Maywood, IL
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