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| ID | Type | Description | Link |
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| K01HL141676 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-SWELL | Experimental | 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. |
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| WE | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-SWELL: Midlife Black Women's Stress Reduction Wellness Program | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 weeks |
| General Self-Efficacy Scale (GSE) |
Inclusion Criteria:
Exclusion Criteria:
Midlife Black/African-American women between the ages of 40 and 64,
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| Name | Affiliation | Role |
|---|---|---|
| Holly J Jones, PhD,RN,NP | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati, College of Nursing | Cincinnati | Ohio | 45219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30272812 | Background | Jones HJ, Norwood CR, Bankston K. Leveraging Community Engagement to Develop Culturally Tailored Stress Management Interventions in Midlife Black Women. J Psychosoc Nurs Ment Health Serv. 2019 Mar 1;57(3):32-38. doi: 10.3928/02793695-20180925-01. Epub 2018 Oct 1. | |
| 31609281 | Background | Jones HJ, Norwood CR, Bankston K, Bakas T. Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. J Cardiovasc Nurs. 2019 Nov/Dec;34(6):483-490. doi: 10.1097/JCN.0000000000000615. |
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We anticipate that there will be manuscripts, not only from the findings addressing Specific Aims 1 and 2, but also from secondary analyses from data generated from this study. We will disseminate results from Specific Aims 1 and 2, as well as results from secondary analyses, in peer-reviewed journals. We will also make the data available to others. Data will be shared with undergraduate honors students, MSN students, DNP students, PhD students, post-doctoral students, and interested faculty members at the University of Cincinnati, College of Nursing, and other institutions.
Data will become available upon completion of the study and remain available for 1 year.
To be determined.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | B-SWELL Intervention Group (B-SWELL) | Black women's stress and wellness intervention |
| FG001 | Wellness (WE) | Comparison group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2022 |
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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.
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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.
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| WE: Wellness program for Midlife Black Women | Behavioral | 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. |
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| 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 |
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. |
| baseline to 12 weeks. |
| 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.' | 8 weeks |
| 29932540 | Background | Jones HJ, Sternberg RM, Janson SL, Lee KA. A Qualitative Understanding of Midlife Sources of Stress and Support in African-American Women. J Natl Black Nurses Assoc. 2016 Jul;27(1):24-30. |
| 35162379 | Background | Jones HJ, Bakas T, Nared S, Humphries J, Wijesooriya J, Butsch Kovacic M. Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. Int J Environ Res Public Health. 2022 Jan 26;19(3):1356. doi: 10.3390/ijerph19031356. |
| 34935740 | Background | Jones HJ, Kovacic MB, Bakas T. Establishing Validity of the Midlife Black Women's Stress-Reduction Wellness Program Materials Using a Mixed Methods Approach. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):446-455. doi: 10.1097/JCN.0000000000000876. Epub 2021 Dec 22. |
| 37905540 | Derived | Jones HJ, Kovacic MB, Bacchus P, Almallah W, Bakas T. Participant Satisfaction in a Cardiovascular Disease Prevention Intervention for Midlife Black Women. West J Nurs Res. 2024 Jan;46(1):3-9. doi: 10.1177/01939459231208420. Epub 2023 Oct 31. |
| 36208220 | Derived | Jones HJ, Butsch Kovacic M, Lambert J, Almallah WR, Becker R, de las Fuentes L, Bakas T. A randomized feasibility trial of the Midlife Black Women's Stress and Wellness intervention (B-SWELL); a community participatory intervention to increase adoption of Life's Simple 7 healthy lifestyle behaviors. Transl Behav Med. 2022 Nov 21;12(11):1084-1095. doi: 10.1093/tbm/ibac075. |
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| ID | Title | Description |
|---|---|---|
| BG000 | B-SWELL Group | The Midlife Black women's Stress and Wellness group (B-SWELL) is the intervention group. |
| BG001 | WE Group | The Wellness (WE) group is the comparison group. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | midlife Black women were recruited between the ages of 40 and 64. Age was self reported using month and birth year. | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | These measures were used to calculate the differences between timepoints for the two groups. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
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| Secondary | 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. | The number of unhealthy days measured within 2 weeks. | Posted | Mean | Standard Deviation | days | baseline to 12 weeks |
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| Secondary | 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'. | Posted | Count of Participants | Participants | Baseline to 12 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline to 12 weeks. |
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| Other Pre-specified | 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.' | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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12 weeks: Time point 1 (0 weeks), Time point 2 ( 8 weeks), and Timepoint 3 (12 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B-SWELL | Intervention group | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | WE - Wellness Group | comparison group | 0 | 23 | 0 | 23 | 0 | 23 |
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Limitations include:
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holly Jones | Ohio State University | 760-415-6147 | jones.7935@osu.edu |
| Nov 16, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D015438 | Health Behavior |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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