Clinical trial NCT03878290: RiSE to Prevent Cardiovascular Disease in African Americans
Official title: RiSE to Prevent Cardiovascular Disease in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Stress
Hypertension
Dyslipidemias
Obesity
Diabetes
Coronary Artery Disease
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 74
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of RiSE intervention: questionnaire
timeFrame: 8 weeks
measure: Coping
timeFrame: 8 weeks
measure: Coping with Discrimination
timeFrame: 8 weeks
measure: Resilience
timeFrame: 8 weeks
Secondary outcomes:
measure: Inflammatory burden
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Karen Saban, PhD
role: PRINCIPAL_INVESTIGATOR
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