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

Trial Summary

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.

What data supports the effectiveness of the treatment Black Women's Stress and Wellness (B-SWELL) for reducing heart disease risk?

Research shows that stress management and lifestyle interventions, like B-SWELL, can help lower blood pressure and improve heart health in Black women. Programs that focus on reducing stress and promoting healthy lifestyle changes have been effective in lowering cardiovascular disease risk factors. ^{1 2 3 4 5}

Is the Lifestyle Intervention for Heart Disease Risk safe for humans?

The studies reviewed suggest that lifestyle interventions, including stress management and wellness programs, are generally safe for Black women and can help reduce cardiovascular risk factors like high blood pressure and obesity. ^{1 3 4 6 7}

How is the B-SWELL treatment different from other treatments for heart disease risk in Black women?

The B-SWELL treatment is unique because it is a culturally tailored program specifically designed for midlife Black women, focusing on stress reduction and wellness to lower heart disease risk. It was co-developed with the community to address the specific needs and challenges faced by this group, making it different from more general heart disease prevention programs. ^{1 2 5 7 8}

What is the purpose of this trial?

This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women. A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric. Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.

Eligibility Criteria

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

Identifies as Black/African American

Willing to adhere to the study requirements

I am between 45 and 64 years old.

Exclusion Criteria

Incarcerated or on house arrest

Diagnosed with terminal illness, severe mental illness, or dementia

I am unable to commit to 8 weekly sessions and 4 phone interviews.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Participant Satisfaction in a Cardiovascular Disease Prevention Intervention for Midlife Black Women. [2023]

2. Scotland pubmed.ncbi.nlm.nih.gov

Preliminary evidence for a race-based stress reduction intervention for Black women at risk for cardiovascular disease. [2022]

3. Scotland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Stress interventions and hypertension in Black women. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Lifestyle management of cardiovascular risk factors in African American women. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Love your heart: a pilot community-based intervention to improve the cardiovascular health of African American women. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. [2022]