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

Stress Clinical Trial

— B-SWELL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404478
• Other study ID #: B-SWELL2019
• Secondary ID: K01HL141676
• Status: Completed
• Phase: N/A
• Start date: February 13, 2021
• Est. completion date: June 12, 2021

Study information

• Verified date: January 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 12, 2021
• Est. primary completion date: June 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 64 Years

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Depression
• Depressive Symptoms
• Health Behavior
• Self Efficacy
• Stress

Intervention

Behavioral:
• B-SWELL: Midlife Black Women's Stress Reduction Wellness Program
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.
• WE: Wellness program for Midlife Black Women
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.

Locations

Country	Name	City	State
United States	University of Cincinnati, College of Nursing	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	baseline to 12 weeks.
Other	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
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.	Baseline to 12 weeks
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.	baseline to 12 weeks
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'.	Baseline to 12 weeks
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.	Baseline to 12 weeks