Clinical trial NCT04404478: Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
Official title: Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Stress
Self Efficacy
Depressive Symptoms
Health Behavior
Keywords: Black women
Stress
Heart disease
Health behaviors
Midlife
Community-based research
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-05-27
Enrollment: 52
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: American Heart Association's Life's Simple Seven (LS7) Score
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Unhealthy Days
timeFrame: baseline to 12 weeks
measure: Perceived General Health
timeFrame: Baseline to 12 weeks
measure: Patient Health Questionnaire (PHQ9)
timeFrame: Baseline to 12 weeks
Other outcomes:
measure: Cohen's Perceived Stress Scale (PSS-10)
timeFrame: Baseline to 12 weeks
measure: General Self-Efficacy Scale (GSE)
timeFrame: baseline to 12 weeks.
measure: Satisfaction (Adapted From Satisfaction Questionnaire).
timeFrame: 8 weeks
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati, College of Nursing
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Holly J Jones, PhD,RN,NP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.