Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04404478
Acronym
B-SWELL
Enrollment
52
Registered
2020-05-27
Start date
2021-02-13
Completion date
2021-06-12
Last updated
2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Depressive Symptoms, Health Behavior, Self Efficacy, Stress

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

BEHAVIORALB-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.

BEHAVIORALWE: 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

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

Sex/Gender
FEMALE
Age
40 Years to 64 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
American Heart Association's Life's Simple Seven (LS7) ScoreBaseline to 12 weeksLife'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

MeasureTime frameDescription
Unhealthy Daysbaseline 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 HealthBaseline to 12 weeksThe 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 weeksThe 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

MeasureTime frameDescription
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 weeksSatisfaction. 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 weeksThe 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

ArmCount
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
Total48

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject13

Baseline characteristics

CharacteristicB-SWELL GroupTotalWE Group
Age, Customized
Age between 40 and 64
25 participants48 participants23 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
25 Participants48 Participants23 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
25 Participants48 Participants23 Participants
Sex: Female, Male
Female
25 Participants48 Participants23 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 23
other
Total, other adverse events
0 / 250 / 23
serious
Total, serious adverse events
0 / 250 / 23

Outcome results

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.

Time frame: Baseline to 12 weeks

Population: These measures were used to calculate the differences between timepoints for the two groups.

ArmMeasureValue (MEAN)Dispersion
B-SWELLAmerican Heart Association's Life's Simple Seven (LS7) Score8.76 units on a scaleStandard Deviation 2.11
WE (Wellness Comparison Group)American Heart Association's Life's Simple Seven (LS7) Score8.21 units on a scaleStandard Deviation 2.5
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.

Time frame: Baseline to 12 weeks

ArmMeasureValue (MEAN)Dispersion
B-SWELLPatient Health Questionnaire (PHQ9)4.80 units on a scaleStandard Deviation 5.17
WE (Wellness Comparison Group)Patient Health Questionnaire (PHQ9)5.39 units on a scaleStandard Deviation 3.2
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'.

Time frame: Baseline to 12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
B-SWELLPerceived General Health17 Participants
WE (Wellness Comparison Group)Perceived General Health13 Participants
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.

Time frame: baseline to 12 weeks

Population: The number of unhealthy days measured within 2 weeks.

ArmMeasureValue (MEAN)Dispersion
B-SWELLUnhealthy Days2.52 daysStandard Deviation 6.26
WE (Wellness Comparison Group)Unhealthy Days3.09 daysStandard Deviation 4.86
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.

Time frame: Baseline to 12 weeks

ArmMeasureValue (MEAN)Dispersion
B-SWELLCohen's Perceived Stress Scale (PSS-10)16.68 units on a scaleStandard Deviation 6.32
WE (Wellness Comparison Group)Cohen's Perceived Stress Scale (PSS-10)15.39 units on a scaleStandard Deviation 5.48
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.

Time frame: baseline to 12 weeks.

ArmMeasureValue (MEAN)Dispersion
B-SWELLGeneral Self-Efficacy Scale (GSE)33.44 units on a scaleStandard Deviation 3.36
WE (Wellness Comparison Group)General Self-Efficacy Scale (GSE)32.91 units on a scaleStandard Deviation 2.7
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.'

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
B-SWELLSatisfaction (Adapted From Satisfaction Questionnaire).4.52 units on a scaleStandard Deviation 0.92
WE (Wellness Comparison Group)Satisfaction (Adapted From Satisfaction Questionnaire).4.30 units on a scaleStandard Deviation 0.7

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026