Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- American Heart Association's Life's Simple Seven (LS7) Score
研究概览
简要总结
This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared to an inattention control wellness group in a randomized control trial. The long-term outcome is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.
详细描述
Cardiovascular disease (CVD) is the primary cause of death in all women, and as women transition through midlife, the prevalence of CVD exceeds that of men.1 Midlife Black women, defined as ages 40-64,unduly shoulder the burden of CVD (49%), hypertension (40%), and heart failure (50% greater risk). Midlife Black women also report higher levels of chronic stress and greater numbers of stressful life events in comparison to midlife White women, putting them at greater risk for CVD. In addition to the physical impact, coping with chronic stress takes time and energy away from self-care, functioning as a barrier to the adoption of healthy lifestyle behaviors. Existent interventions do not fully address the unique factors contributing to the experience of stress, lifestyle behaviors, and CVD risk in midlife Black women.
The purpose of this research proposal is to develop a midlife Black women's Stress-reduction WELLness intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors and themes identified in preliminary research. Community-based participatory research (CBPR) methods will be used to engage the community and include midlife Black women in the development of the B-SWELL. We propose that the skills and knowledge gained through participation in the B-SWELL program will increase receptivity to the healthy lifestyle behaviors outlined in the American Heart Association's Life Simple 7 Success Plan (LS7). The LS7 targets seven risk factors known to increase cardiovascular related health risk: cholesterol, fasting glucose, blood pressure, body mass index, physical activity, diet, and smoking.
Our hypothesis proposes that low stress scores and greater self efficacy will be associated with the adoption of AHA's healthy lifestyle behaviors. Low stress and self efficacy will be facilitated through peer support and culturally relevant content, materials, and themes. B-SWELL participants will show improved self-efficacy in managing life stress and adopting the LS7 behaviors, compared to a control group receiving traditional wellness education (WE group).
Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative leveraging of CBPR methodology and LS7 modifiable healthy lifestyle behaviors.
- To develop components of the B-SWELL intervention prototype for midlife Black women.
- Obtain ratings of the new components of the B-SWELL from our community advisory board for degree of accuracy, relevance, and feasibility to inform further refinements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants will be randomized into groups. Group sessions held online on different dates and times. Participants are asked not to share details about the study. Data collectors are blinded to participant grouping. Facilitators are blinded to the groups they are not facilitating.
入排标准
- 年龄范围
- 40 Years 至 64 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •fluent in the English language,
- •ability to hear and talk well enough to engage in everyday conversation,
- •access to a telephone with messaging,
- •access to WIFI,
- •willingness to participate for duration of the study.
排除标准
- •recent immigration to the U.S.,
- •prisoner or on house arrest,
- •pregnant,
- •terminal illness (i.e., late stage cancer, end-of-life condition, renal failure requiring dialysis),
- •history of Alzheimer's, dementia, or severe mental illness (i.e., suicidal tendencies, schizophrenia, or severe untreated depression),
- •any other major health conditions or disabilities prohibiting safe participation in the program.
结局指标
主要结局
American Heart Association's Life's Simple Seven (LS7) Score
时间窗: Baseline to 12 weeks
Life's Simple 7 score measures cardiovascular health. Minimum score is 0. Maximum score is 14. Each of the 7 metrics (weight loss, diet, exercise, cholesterol management, glucose management, smoking, and blood pressure management) is rated 0 (poor), 1 (average), or 2 (best). Higher scores indicate greater cardiovascular health. Lower scores indicate greater risk for heart disease.
次要结局
- Unhealthy Days(baseline to 12 weeks)
- Perceived General Health(Baseline to 12 weeks)
- Patient Health Questionnaire (PHQ9)(Baseline to 12 weeks)
研究者
Holly Jones
Assistant Professor
University of Cincinnati
