RiSE to Prevent Cardiovascular Disease in African Americans

October 22, 2019 updated by: Karen Saban, Loyola University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Treatment as usual
Experimental: 8-week RiSE
Participate in 8-week Resilience, Stress, and Ethnicity (RiSE) group based stress reduction program in which participants meet every week for approximately 2 hours for 8 consecutive weeks.
Behavioral: Resilience, Stress, and Ethnicity (RiSE)
Group based stress reduction program focused on helping minorities develop coping and empowerment skills
Other Names:
  • RiSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of RiSE intervention: questionnaire
Time Frame: 8 weeks
Feasibility of the RiSE intervention will be assessed at the end of the 8 week program. A written questionnaire will be completed by participants and asking participants to rate their level of satisfaction with the program on a scale of 0 to 10 with 0 being not satisfied at all to 10 being most satisfied. In addition, we will track class attendance and attrition rate.
8 weeks
Coping
Time Frame: 8 weeks

Participants will complete written questionnaires at baseline, 4 weeks, and 8 weeks:

Adaptive Coping. The Ways of Coping Checklist- Revised (WCCL-R) will be used to measure adaptive and non-adaptive coping. This is a 4-point Likert scale (0 to 3 ) that required the respondent to focus on a current stressor and to choose frequency of each of 66 proposed coping strategies. The WCCL-R is comprised of 5 subscales (scores are summed for each subscale) with higher scores indicating higher levels of the attribute measured by the subscale:

Confrontational coping (scores range from 0 to 18) Distancing (scores range from 0 to 18) Self-controlling (scores range from 0 to 21) Seeking social support (scores range from 0 to 18) Accepting responsibility (scores range from 0 to 12) Escape-avoidance (scores range from 0 to 24) Planful problem-solving (scores range from 0 to 15) Positive reappraisal (scores range from 0 to 21)
8 weeks
Coping with Discrimination
Time Frame: 8 weeks
Coping with Discrimination. The Coping with Discrimination Scale (CDS) is a 25-item scale that assesses coping strategies with discrimination. Items are answered using a 6-point Likert scale format ranging from strongly agree to strongly disagree. Scores are calculated for 5 subscales: Education/advocacy, Internalization, Drug/alcohol use, Resistance, and Detachment. Mean scores for each subscale range from 1 to 6 with higher scores indicating higher presence of the attribute measured.
8 weeks
Resilience
Time Frame: 8 weeks
Resilience. The Connor-Davidson Resilience Scale- 25 will be used to measure resilience. The Connor Davidson Resilience Scale-25 is a 25 item questionnaire that examines the extent to which statements representing resilience, such as " I am able to adapt when changes occur" are true for the subject. Each item is evaluated on a five point Likert scale ranging from 0-4: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). Scores for items are summed and result in total score between 0-100 with higher scores indicating higher resilience.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory burden
Time Frame: 8 weeks

Inflammatory burden will be measured at baseline and 8 weeks.

Cytokine. ELISA will be used to measure circulating interleukin-6 (IL-6) (R & D Systems, Minneapolis MN). Sensitivity is < 0.7 pg/ml for IL-6. Intra assay variability is <7 %. Circulating IL-6 will be collected at baseline and 8 wks in both the intervention and control groups. Labs will be centrifuged for 7 minutes and frozen at -80 C for later batch analysis.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Karen Saban, PhD, Loyola University Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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