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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Depressive Symptoms; Health Behavior; Cardiovascular Risk Factor; Self Efficacy
• Intervention / Treatment: Behavioral: B-SWELL: Midlife Black Women's Stress Reduction Wellness Program; Behavioral: WE: Wellness program for 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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati, College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: B-SWELL; 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; 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.
ACTIVE_COMPARATOR: WE; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in American Heart Association's Life's Simple Seven (LS7) score	LS7 focuses on seven key healthy lifestyle behaviors: 1) weight loss, 2) diet, 3) exercise, 4) cholesterol management, 5) glucose management, 6) smoking, and 7) blood pressure management. Each behavior is given a score: 0 (poor), 1 (average), or 2 (best) with a maximum score of 14. Higher scores indicate trend towards optimal health behaviors and lower risk for heart disease.	Change from baseline to 8 weeks and from 8 weeks to 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the 'Number of Unhealthy Days'	The 'Number of Unhealthy Days' question asks the participant how many days in past month that their physical/mental health was not good. The number of unhealthy days reported will be compared from baseline.	Change from baseline to 8 weeks and from 8 weeks to 12 weeks.
Change in 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'.	Change from baseline to 8 weeks and from 8 weeks to 12 weeks.
Change in Patient Health Questionnaire (PHQ9)	The PHQ9 measures depressive symptoms. Participants are asked to 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 depression.	Change from baseline to 8 weeks and from 8 weeks to 12 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cohen's Perceived Stress Scale (PSS-10)	The 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.	Change from baseline to 8 weeks and from 8 weeks to 12 weeks.
Change in 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 more self-efficacy.	Change from baseline to 8 weeks and from 8 weeks to 12 weeks.
Satisfaction (Adapted from Satisfaction questionnaire)	Participants will rate their satisfaction of the overall B-SWELL program. The questionnaire will include ratings for usefulness, ease of use, and acceptability of the intervention. Ratings will be averaged across the participants, with possible scores ranging from 1=strongly disagree to 5=strongly agree. averaged across the experts, with possible scores ranging from 1=strongly disagree to 5=strongly agree.	8 weeks

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Holly J Jones, PhD,RN,NP, University of Cincinnati

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2021
• Primary Completion (ACTUAL): June 12, 2021
• Study Completion (ACTUAL): June 12, 2021

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 30, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Stress; Heart disease; Black women; Midlife; Health behaviors; Community-based research
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: B-SWELL2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available upon completion of the study and remain available for 1 year.
• IPD Sharing Access Criteria: To be determined.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No