RiSE to Prevent Cardiovascular Disease in African Americans
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).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Illinois
-
Maywood, Illinois, Estados Unidos, 60153
- Loyola University Chicago
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Ao controle
Tratamento como de costume
|
|
|
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.
|
Group based stress reduction program focused on helping minorities develop coping and empowerment skills
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of RiSE intervention: questionnaire
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Inflammatory burden
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Karen Saban, PhD, Loyola University Chicago
Publicações e links úteis
Publicações Gerais
- 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. Circulation. 2017 Sep 5;136(10 ):e196.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 210130
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .