Cardiovascular Risk Factor, Depressive Symptoms, Health Behavior, Self Efficacy, Stress
Conditions
Keywords
Black women, Stress, Heart disease, Health behaviors, Midlife, Community-based research
Brief summary
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
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. 1. To develop components of the B-SWELL intervention prototype for midlife Black women. 2. 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): 1. Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for the intervention procedures for both groups; 2. 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. 3. 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.
Interventions
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.
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.
Sponsors
Study design
Masking description
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.
Intervention 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.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Heart Association's Life's Simple Seven (LS7) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unhealthy Days | baseline to 12 weeks | '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. |
| Perceived General Health | Baseline to 12 weeks | 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'. |
| Patient Health Questionnaire (PHQ9) | Baseline to 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| General Self-Efficacy Scale (GSE) | baseline to 12 weeks. | The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with life demands. The total score is calculated by finding the sum of the all items. Scores range from 1 (not at all true) to 4 (exactly true). Total scores range between 10 and 40. A higher score indicates greater self-efficacy in achieving a particular outcome. Lower scores indicate the participant has less self-efficacy in achieving the outcome. |
| Satisfaction (Adapted From Satisfaction Questionnaire). | 8 weeks | Satisfaction. Participants rate their satisfaction of the overall B-SWELL program using a Likert type scale ranging from 1=strongly disagree to 5=strongly agree. The questionnaire includes items for usefulness, ease of use, and acceptability of the intervention. Ratings are averaged across participants. The results reported here refer to the question: 'The weekly program materials addressed the problems I was having as a midlife Black woman.' |
| Cohen's Perceived Stress Scale (PSS-10) | Baseline to 12 weeks | The Perceived stress scale (PSS-10) measures a person's perception of general stress. Items are rated on a scale of 0 to 4 with a maximum score of 40. Higher levels of stress correspond with higher scores. Low scores indicate less stress. |
Countries
United States
Participant flow
Recruitment details
Women were recruited from the community using fliers, social media, email list serves, and word of mouth. The recruitment efforts were led by community partners. Recruitment was completed within 7 weeks.
Pre-assignment details
Of the 52 persons randomized and enrolled in the study, 3 persons withdrew prior to the start of the study (week 1) and 1 person was withdrawn prior to week 2 for lack of participation.
Participants by arm
| Arm | Count |
|---|---|
| B-SWELL Group The Midlife Black women's Stress and Wellness group (B-SWELL) is the intervention group. | 25 |
| WE Group The Wellness (WE) group is the comparison group. | 23 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | B-SWELL Group | Total | WE Group |
|---|---|---|---|
| Age, Customized Age between 40 and 64 | 25 participants | 48 participants | 23 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 48 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 25 Participants | 48 Participants | 23 Participants |
| Sex: Female, Male Female | 25 Participants | 48 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
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.
Time frame: Baseline to 12 weeks
Population: These measures were used to calculate the differences between timepoints for the two groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B-SWELL | American Heart Association's Life's Simple Seven (LS7) Score | 8.76 units on a scale | Standard Deviation 2.11 |
| WE (Wellness Comparison Group) | American Heart Association's Life's Simple Seven (LS7) Score | 8.21 units on a scale | Standard Deviation 2.5 |
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.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B-SWELL | Patient Health Questionnaire (PHQ9) | 4.80 units on a scale | Standard Deviation 5.17 |
| WE (Wellness Comparison Group) | Patient Health Questionnaire (PHQ9) | 5.39 units on a scale | Standard Deviation 3.2 |
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'.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B-SWELL | Perceived General Health | 17 Participants |
| WE (Wellness Comparison Group) | Perceived General Health | 13 Participants |
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.
Time frame: baseline to 12 weeks
Population: The number of unhealthy days measured within 2 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B-SWELL | Unhealthy Days | 2.52 days | Standard Deviation 6.26 |
| WE (Wellness Comparison Group) | Unhealthy Days | 3.09 days | Standard Deviation 4.86 |
Cohen's Perceived Stress Scale (PSS-10)
The Perceived stress scale (PSS-10) measures a person's perception of general stress. Items are rated on a scale of 0 to 4 with a maximum score of 40. Higher levels of stress correspond with higher scores. Low scores indicate less stress.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B-SWELL | Cohen's Perceived Stress Scale (PSS-10) | 16.68 units on a scale | Standard Deviation 6.32 |
| WE (Wellness Comparison Group) | Cohen's Perceived Stress Scale (PSS-10) | 15.39 units on a scale | Standard Deviation 5.48 |
General Self-Efficacy Scale (GSE)
The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with life demands. The total score is calculated by finding the sum of the all items. Scores range from 1 (not at all true) to 4 (exactly true). Total scores range between 10 and 40. A higher score indicates greater self-efficacy in achieving a particular outcome. Lower scores indicate the participant has less self-efficacy in achieving the outcome.
Time frame: baseline to 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B-SWELL | General Self-Efficacy Scale (GSE) | 33.44 units on a scale | Standard Deviation 3.36 |
| WE (Wellness Comparison Group) | General Self-Efficacy Scale (GSE) | 32.91 units on a scale | Standard Deviation 2.7 |
Satisfaction (Adapted From Satisfaction Questionnaire).
Satisfaction. Participants rate their satisfaction of the overall B-SWELL program using a Likert type scale ranging from 1=strongly disagree to 5=strongly agree. The questionnaire includes items for usefulness, ease of use, and acceptability of the intervention. Ratings are averaged across participants. The results reported here refer to the question: 'The weekly program materials addressed the problems I was having as a midlife Black woman.'
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B-SWELL | Satisfaction (Adapted From Satisfaction Questionnaire). | 4.52 units on a scale | Standard Deviation 0.92 |
| WE (Wellness Comparison Group) | Satisfaction (Adapted From Satisfaction Questionnaire). | 4.30 units on a scale | Standard Deviation 0.7 |