Skip to main content
OpenTrials
Completed

NCT Number: NCT04404478

Stress-reduction Wellness Program for Midlife Black Women (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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati, College of Nursing

Cincinnati, Ohio, 45219, United States

About this study

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.

  • To develop components of the B-SWELL intervention prototype for midlife Black women.
  • 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):

  • Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for the intervention procedures for both groups;
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. American Heart Association's Life's Simple Seven (LS7) Score

    Time frame: Baseline to 12 weeks

    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.

Secondary outcomes

  1. Unhealthy Days

    Time frame: baseline 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.

  2. Perceived General Health

    Time frame: Baseline to 12 weeks

    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'.

  3. Patient Health Questionnaire (PHQ9)

    Time frame: Baseline to 12 weeks

    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.

Other outcomes

  1. Cohen's Perceived Stress Scale (PSS-10)

    Time frame: Baseline to 12 weeks

    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.

  2. General Self-Efficacy Scale (GSE)

    Time frame: 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.

  3. Satisfaction (Adapted From Satisfaction Questionnaire).

    Time frame: 8 weeks

    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.'

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: B-SWELL

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 27, 2020
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.