64 Participants Needed

Lifestyle Intervention for Heart Disease Risk

SS
DH
Overseen ByDr. Holly J Jones, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Phase 2
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the Black Women's Stress and Wellness (B-SWELL) program might reduce heart disease risk in midlife Black women by emphasizing stress reduction and healthier lifestyle habits. Participants will be randomly assigned to either B-SWELL, which includes stress management and personalized health coaching, or a wellness education group that follows heart health guidelines. Both groups last eight weeks and can be attended in person or online. Black women living in Greater Cincinnati, aged 45-64, who can commit to weekly sessions and phone interviews, may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant health advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on lifestyle changes rather than medication adjustments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Black Women's Stress and Wellness (B-SWELL) program is safe and easy to follow. Studies on B-SWELL have found that it helps participants reduce stress and receive personalized health coaching to adopt healthier habits. Designed specifically for midlife Black women, the program aims to lower the risk of heart disease by improving heart health and lifestyle choices. Previous trials reported no major safety issues or negative effects from the program. Participants can feel confident about the program's safety, as it addresses their specific needs.12345

Why are researchers excited about this trial?

Researchers are excited about the B-SWELL approach because it offers a culturally tailored intervention specifically for Black women, focusing on reducing stress and promoting heart health through personalized health coaching. Unlike standard treatments for heart disease risk, which often involve medication or generic lifestyle advice, B-SWELL emphasizes stress reduction and lifestyle changes using the American Heart Association's Life's Essential 8 metrics. This personalized and culturally relevant method could potentially be more effective in engaging participants and leading to sustainable health improvements.

What evidence suggests that this trial's treatments could be effective for reducing heart disease risk in midlife Black women?

Research has shown that the B-SWELL program, which participants in this trial may receive, can improve heart health in midlife Black women by reducing stress and promoting healthier lifestyle choices. Studies have found that the program uses education, stress relief, and goal setting to build confidence in making healthy changes. B-SWELL is specially designed with sessions that consider cultural needs to lower the risk of heart disease. Participants in past studies demonstrated positive changes in their heart health and lifestyle habits. These encouraging results suggest that B-SWELL could effectively manage heart disease risk in this group. Meanwhile, another arm of this trial, the Wellness (WE) arm, serves as an attention control group focusing on the Life's Essential 8 metrics.12346

Are You a Good Fit for This Trial?

This trial is for midlife Black women aged 45-64 living in the Greater Cincinnati area. Participants must self-identify as Black/African American, be willing to attend weekly sessions and phone interviews, and commit to study requirements.

Inclusion Criteria

I am between 45 and 64 years old.
Identifies as Black/African American
Willing to adhere to the study requirements

Exclusion Criteria

I am unable to commit to 8 weekly sessions and 4 phone interviews.
Incarcerated or on house arrest
Diagnosed with terminal illness, severe mental illness, or dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 8-weekly sessions focusing on stress reduction, heart disease awareness, and healthy lifestyle changes. Sessions last 90 minutes and can be attended in person or virtually.

8 weeks
8 visits (in-person or virtual)

Follow-up

Participants are monitored for adherence, healthy lifestyle behaviors, and cardiovascular health using the Life's Essential 8 metric. Survey phone interviews are conducted at 8, 12, and 16 weeks.

8 weeks
3 phone interviews

Booster Sessions

Booster sessions are conducted to reinforce the intervention at weeks 10 and 14.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Black Women's Stress and Wellness (B-SWELL)
  • Wellness (WE)
Trial Overview The B-SWELL program aims to reduce heart disease risk by promoting stress reduction and healthy lifestyles. Women will be randomly assigned to either the B-SWELL or a Wellness (WE) group for an 8-week intervention, with options for in-person or virtual participation.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Black Women's Stress and Wellness (B-SWELL) armExperimental Treatment1 Intervention
Group II: Wellness (WE) armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Published Research Related to This Trial

The B-SWELL intervention, designed specifically for midlife Black women to reduce cardiovascular disease risk, received high satisfaction ratings (mean score of 4.57) in a feasibility trial with 48 participants, indicating its acceptability and effectiveness.
Culturally tailored interventions developed with community input can enhance recruitment and retention of underrepresented populations in clinical trials, demonstrating the importance of cultural adaptation in health interventions.
Participant Satisfaction in a Cardiovascular Disease Prevention Intervention for Midlife Black Women.Jones, HJ., Kovacic, MB., Bacchus, P., et al.[2023]
The 'Resilience, Stress, and Ethnicity (RiSE)' program showed promise in helping Black women at risk for cardiovascular disease (CVD) by significantly reducing avoidance coping strategies over an 8-week period, with 40 participants in the intervention group.
While reductions in inflammatory markers TNF-alpha and hsCRP were observed, they did not reach statistical significance, indicating that further research is needed to confirm the anti-inflammatory benefits of the RiSE program.
Preliminary evidence for a race-based stress reduction intervention for Black women at risk for cardiovascular disease.Saban, KL., Motley, D., Shawahin, L., et al.[2022]
The B-SWELL program was specifically designed to address the higher rates of heart disease and stroke among midlife Black women by increasing awareness of cardiovascular disease (CVD) risk factors and promoting healthy lifestyle behaviors.
The program utilized community participatory methods to develop culturally tailored materials, highlighting the importance of community involvement in creating effective health interventions for underrepresented groups.
Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women.Jones, HJ., Bakas, T., Nared, S., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36208220/
A randomized feasibility trial of the Midlife Black Women's ...The B-SWELL program uses education, stress reduction, and goal setting to improve healthy lifestyle behaviors in midlife Black women.
Stress-reduction Wellness Program for Midlife Black ...The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will ...
Journal of Cardiovascular NursingThe B-SWELL intervention is a culturally tailored 8-week intervention designed to lower cardiovascular disease risk in midlife Black women by leveraging stress ...
Abstract 9394: Establishing Validity of a Midlife Black ...Methods: The B-SWELL is a culturally tailored 8-week program that leverages stress reduction to lower cardiovascular disease (CVD) risk in ...
A randomized feasibility trial of the Midlife Black Women's ...The B-SWELL is a culturally tailored group intervention that leverages stress reduction to lower heart disease risk among midlife Black women.
Using Life's Essential 8 in Midlife Black WomenThis research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease ...
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