RiSE to Prevent Cardiovascular Disease in African Americans

NCT03878290 | Completed

• 1 other identifier: 210130
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Atherosclerosis; Stress; Hypertension; Dyslipidemias; Obesity; Diabetes; Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• Feasibility of RiSE intervention: questionnaire

  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

  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

  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

  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 Outcomes (1)

• Inflammatory burden

  8 weeks

Study Arms (2)

8-week RiSE

EXPERIMENTAL

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)

Control

NO INTERVENTION

Treatment as usual

Interventions

Resilience, Stress, and Ethnicity (RiSE) BEHAVIORAL

Group based stress reduction program focused on helping minorities develop coping and empowerment skills

Also known as: RiSE

8-week RiSE

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

Related Publications (13)

• Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• Wong MD, Shapiro MF, Boscardin WJ, Ettner SL. Contribution of major diseases to disparities in mortality. N Engl J Med. 2002 Nov 14;347(20):1585-92. doi: 10.1056/NEJMsa012979.

  PMID: 12432046 BACKGROUND

• Wagner J, Abbott G. Depression and depression care in diabetes: relationship to perceived discrimination in African Americans. Diabetes Care. 2007 Feb;30(2):364-6. doi: 10.2337/dc06-1756. No abstract available.

  PMID: 17259510 BACKGROUND

• Belgrave FZ, Abrams JA. Reducing disparities and achieving equity in African American women's health. Am Psychol. 2016 Nov;71(8):723-733. doi: 10.1037/amp0000081.

  PMID: 27977253 BACKGROUND

• Mouton CP, Hayden M, Southerland JH. Cardiovascular Health Disparities in Underserved Populations. Prim Care. 2017 Mar;44(1):e37-e71. doi: 10.1016/j.pop.2016.09.019.

  PMID: 28164826 BACKGROUND

• Wagner J, Lampert R, Tennen H, Feinn R. Exposure to Discrimination and Heart Rate Variability Reactivity to Acute Stress among Women with Diabetes. Stress Health. 2015 Aug;31(3):255-62. doi: 10.1002/smi.2542. Epub 2013 Nov 6.

  PMID: 24194397 BACKGROUND

• Mwendwa DT, Sims RC, Madhere S, Thomas J, Keen LD 3rd, Callender CO, Campbell AL Jr. The influence of coping with perceived racism and stress on lipid levels in African Americans. J Natl Med Assoc. 2011 Jul;103(7):594-601. doi: 10.1016/s0027-9684(15)30385-0.

  PMID: 21999034 BACKGROUND

• Wyatt SB, Williams DR, Calvin R, Henderson FC, Walker ER, Winters K. Racism and cardiovascular disease in African Americans. Am J Med Sci. 2003 Jun;325(6):315-31. doi: 10.1097/00000441-200306000-00003.

  PMID: 12811228 BACKGROUND

• Williams DR, Jackson PB. Social sources of racial disparities in health. Health Aff (Millwood). 2005 Mar-Apr;24(2):325-34. doi: 10.1377/hlthaff.24.2.325.

  PMID: 15757915 BACKGROUND

• Paradies Y. A systematic review of empirical research on self-reported racism and health. Int J Epidemiol. 2006 Aug;35(4):888-901. doi: 10.1093/ije/dyl056. Epub 2006 Apr 3.

  PMID: 16585055 BACKGROUND

• Sutin AR, Stephan Y, Carretta H, Terracciano A. Perceived discrimination and physical, cognitive, and emotional health in older adulthood. Am J Geriatr Psychiatry. 2015 Feb;23(2):171-9. doi: 10.1016/j.jagp.2014.03.007. Epub 2014 Mar 21.

  PMID: 24745563 BACKGROUND

• Todorova IL, Falcon LM, Lincoln AK, Price LL. Perceived discrimination, psychological distress and health. Sociol Health Illn. 2010 Sep;32(6):843-61. doi: 10.1111/j.1467-9566.2010.01257.x. Epub 2010 Jul 23.

  PMID: 20649891 BACKGROUND

• Utsey SO, Payne YA, Jackson ES, Jones AM. Race-related stress, quality of life indicators, and life satisfaction among elderly African Americans. Cultur Divers Ethnic Minor Psychol. 2002 Aug;8(3):224-33. doi: 10.1037/1099-9809.8.3.224.

  PMID: 12143100 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Hypertension; Dyslipidemias; Obesity; Diabetes Mellitus; Coronary Artery Disease

Interventions

Ethnicity

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Karen Saban, PhD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Niehoff School of Nursing

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: August 3, 2017
• Primary Completion: July 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)