Lifestyle Intervention for Heart Disease Risk

Overseen By Dr. Holly J Jones, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Ohio State University

Disqualifiers: Incarceration, Terminal illness, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

64 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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?

Group I: Black Women's Stress and Wellness (B-SWELL) arm Experimental Treatment 1 Intervention

The B-SWELL arm consists of 8-weekly sessions. Sessions last 90 minutes and focus on stress reduction, heart disease, and healthy lifestyle changes. The American Heart Association's Life's Essential 8 metrics are leveraged and culturally tailored in the B-SWELL materials. Participants will also receive personalized health coaching.

Group II: Wellness (WE) arm Active Control 1 Intervention

This is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics. Sessions will last approximately 90 minutes.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. Jones, HJ., Bakas, T., Nared, S., et al.[2022]

The Love Your Heart program, a 12-week culturally-tailored nutrition and physical activity intervention, effectively reduced hypertension and elevated waist circumference among 34 African American women, highlighting its potential to improve cardiovascular health.

This pilot study suggests that community-based interventions can significantly address health disparities and reduce cardiovascular risk factors in minority populations, despite the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Love your heart: a pilot community-based intervention to improve the cardiovascular health of African American women. Rodriguez, F., Christopher, L., Johnson, CE., et al.[2022]

A 12-week community-based lifestyle intervention program for African American women led to significant weight loss and reduced blood pressure, highlighting the effectiveness of nutrition education and counseling.

Participants who actively engaged in the program, which focused on increasing physical activity and improving dietary habits, experienced positive changes in their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle management of cardiovascular risk factors in African American women. Brennen, M., Williams, CL.[2022]

A qualitative study involving a community advisory board of 11 midlife black women identified effective stress reduction strategies such as exercise, faith and prayer, self-care, and mindfulness, which are crucial for addressing cardiovascular health disparities.

Barriers to implementing these stress reduction strategies included time constraints, financial issues, and health limitations, highlighting the need for tailored interventions that consider these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. Jones, HJ., Norwood, CR., Bankston, K., et al.[2022]

Stress management interventions, particularly meditation-based approaches, have been shown to reduce blood pressure in Black women, with 13 out of 18 studies demonstrating positive outcomes.

There is a significant gap in research specifically targeting Black women, as most studies had small sample sizes and did not analyze results by race and gender, highlighting the need for more focused investigations into effective hypertension management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress interventions and hypertension in Black women. Kalinowski, J., Kaur, K., Newsome-Garcia, V., et al.[2022]

The 8-week group-based stress reduction program, Resilience, Stress and Ethnicity (RiSE), was found to be feasible and effective for Black women at risk for cardiovascular disease, with a low attrition rate of 13% and high participant satisfaction.

Participants reported significant improvements in coping with stress related to perceived discrimination and racism, with 81% practicing the skills learned in real-life situations, indicating the program's potential to address chronic stress and reduce health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative evidence for Resilience, Stress, and Ethnicity (RiSE): A program to address race-based stress among Black women at risk for cardiovascular disease. Conway-Phillips, R., Dagadu, H., Motley, D., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04404478

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 ...

3. journals.lww.com journals.lww.com/10.1097/JCN.0000000000000876

Journal of Cardiovascular Nursing The B-SWELL intervention is a culturally tailored 8-week intervention designed to lower cardiovascular disease risk in midlife Black women by leveraging stress ...

4. ahajournals.org ahajournals.org/doi/10.1161/circ.144.suppl_1.9394?doi=10.1161/circ.144.suppl_1.9394

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9677463/

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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06707636

Using Life's Essential 8 in Midlife Black Women This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease ...