Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black women randomized to the B-SWELL intervention (25) or to a wellness education (WE) control group (25): Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for the intervention procedures for both groups; Compare mediator measures (stress, self-efficacy) for participants in the B-SWELL intervention group with those in the WE group at 8 and 12 weeks. Compare outcome measures (LS7 summary scores, unhealthy days, general health, depressive symptoms) for participants in the B-SWELL intervention group with those in the WE attention control group at 8 and 12 weeks.

Official Title
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Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)

Conditions
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Self Efficacy, Depressive Symptoms, Cardiovascular Risk Factor, Stress, Health Behavior

Intervention / Treatment
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* Behavioral: B-SWELL: Midlife Black Women's Stress Reduction Wellness Program
* Behavioral: WE: Wellness program for Midlife Black Women


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial comparing intervention group (B-SWELL) with an attention control group (WE) to assess the following outcomes: healthy lifestyle scores, perceived stress scores, self efficacy, unhealthy days, and depressive symptoms.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B-SWELL<br>Participants in the B-SWELL intervention will receive information about stress and goal setting in addition to healthy lifestyle behaviors. The intervention will take place weekly for eight weeks in groups of 11 to 13 midlife Black women for peer support. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks. | Behavioral: B-SWELL: Midlife Black Women's Stress Reduction Wellness Program<br>* Stress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information.<br>|
| Active Comparator: WE<br>The attention control group (WE), will include education about healthy lifestyle behaviors and peer support. The attention control groups will also have weekly sessions for eight weeks in groups of 11 to 13 midlife Black women. Outcome measures will include perceived general health, depressive symptoms, life's simple 7 (LS7) score, and number of unhealthy days. Data collections will occur at baseline, 8 weeks, and 12 weeks. | Behavioral: WE: Wellness program for Midlife Black Women<br>* Culturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Heart Association's Life's Simple Seven (LS7) Score | 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. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unhealthy Days | 'Unhealthy Days' is measures by the number of unhealthy days reported by the participant. This question asks the participant how many days in past month that their physical/mental health was not good. This is a continuous numeric response. Higher numbers indicate poorer health during the reported timeframe. | baseline to 12 weeks | 
| Perceived General Health | The Perceived General Health question is one item from the Short Form Health Survey. The participants will rate their health as 'excellent', 'very good', 'good', 'fair' and 'poor'. Responses are categorical. The reported outcome reflects the number of participants who rate their health as 'good'. | Baseline to 12 weeks | 
| Patient Health Questionnaire (PHQ9) | The PHQ9 measures depressive symptoms. Participants rate their depressive symptoms from '0' (not at all) to '3' (every day). Scores range from 0 to 27. Higher scores indicate greater risk of clinical depression. Lower scores indicate less risk for depression. | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Black women, Stress, Heart disease, Health behaviors, Midlife, Community-based research