Lifestyle Intervention for Heart Disease Risk

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Ohio State University

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

No Placebo Group

Prior Safety Data

Trial Summary

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.

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}

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.

Trial 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) (Behavioural Intervention)
• Wellness (WE) (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ohio State University Cincinnati, OH

Who Is Running the Clinical Trial?

Ohio State University Lead Sponsor

References

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

Participant Satisfaction in a Cardiovascular Disease Prevention Intervention for Midlife Black Women. [2023] Midlife Black women suffer disproportionately from cardiovascular disease and are 65% more likely to die following a cardiac event compared with White women. Recruitment and retention of midlife Black women in clinical trials has been historically low. The culturally tailored Midlife Black Women's Stress Reduction and Wellness (B-SWELL) intervention was codeveloped with the community and designed to lower cardiovascular disease risk in midlife Black women.

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] Despite evidence that chronic stress, racism, and discrimination impact the well-being and the risk for cardiovascular disease (CVD) in Black women, there are few evidence-based interventions that improve well-being and reduce the risk for CVD in women of minority groups. The purpose of this pilot study was to evaluate the psychobehavioral and anti-inflammatory benefit of a race-based stress reduction program "Resilience, Stress, and Ethnicity (RiSE) for Black women at risk for CVD.

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] Growing evidence demonstrates that perceived discrimination and racism are significant contributing factors to psychological distress, low-grade chronic inflammation, and cardiovascular health disparities among minorities, particularly among Black women. Despite this evidence, there are no evidence-based complementary therapy interventions available to ameliorate chronic stress associated with racism and discrimination. The purpose of this study was to examine the feasibility and effectiveness of a novel, 8-week, group-based stress reduction program, Resilience, Stress and Ethnicity (RiSE), designed to help Black women at risk for cardiovascular disease (CVD) develop effective coping skills for dealing with chronic stress uniquely associated with being a minority.

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

Stress interventions and hypertension in Black women. [2022] Hypertension is a risk factor for cardiovascular disease. Black women have high rates of hypertension compared to women of other racial or ethnic groups and are disproportionately affected by psychosocial stressors such as racial discrimination, gender discrimination, and caregiving stress. Evidence suggests that stress is associated with incident hypertension and hypertension risk. Stress management is associated with improvements improved blood pressure outcomes. The purpose of this review is to synthesize evidence on effects of stress management interventions on blood pressure in Black women. A comprehensive search of scientific databases was conducted. Inclusion criteria included studies that were: (1) primary research that tested an intervention; (2) in the English language; (3) included African-American women; (4) incorporated stress in the intervention; (5) included blood pressure as an outcome; and (6) were US based. Eighteen studies met inclusion criteria. Ten (56%) studies tested meditation-based interventions, two (11%) tested coping and affirmation interventions, and six (33%) tested lifestyle modification interventions that included stress management content. Thirteen of the studies were randomized controlled trials. Reductions in blood pressure were observed in all of the meditation-based interventions, although the magnitude and statistical significance varied. Comprehensive lifestyle interventions were also efficacious for reducing blood pressure, although the relative contribution of stress management versus behavior modification could not be evaluated. Coping and affirmation interventions did not affect blood pressure. Most of the reviewed studies included small numbers of Black women and did not stratify results by race and gender, so effects remain unclear. This review highlights the urgent need for studies specifically focusing on Black women. Given the extensive disparities in cardiovascular disease morbidity and mortality, whether stress management can lower blood pressure and improve primary and secondary cardiovascular disease prevention among Black women is an important question for future research.

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

Lifestyle management of cardiovascular risk factors in African American women. [2022] African American women have the highest prevalence of obesity in the nation when compared to Caucasian and Hispanic women. The purpose of this project was to evaluate the effect of nutrition education and counseling on weight loss, blood pressure, self- efficacy and perception of power. The project was a 12 week community-based lifestyle intervention program designed to provide counseling and education on increasing physical activity, dietary intake of fruits and vegetables while, decreasing dietary intake salt and fat. The results showed that the women, who engaged in all aspects of the program, were able to lose weight and lower their blood pressure.

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

Stress Reduction Strategies Used by Midlife Black Women to Target Cardiovascular Risk. [2022] Midlife black women are at a high risk for cardiovascular disease and experience higher morbidity and mortality rates. Chronic life stress contributes to the existent cardiovascular-related disparities for midlife black women.

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] Cardiovascular disease remains the leading cause of death for women, and racial and ethnic minority groups disproportionately suffer from cardiovascular risk factors. We developed an intensive, culturally-tailored 12-week nutrition and physical activity program, Love Your Heart, to reduce cardiovascular risk factors for African American women in the Boston area from January to April 2011. The pilot study partnered an academic institution with two community-based organizations, the Boston Black Women's Health Institute (BBWHI) and Body by Brandy Wellness Center (BBBWC). The study sample consisted of 34 women with a mean age of 48 years (SD +/- 3), with high rates of hypertension (79%), obesity (79%), and elevated waist circumference (94%). Over 12 weeks of follow-up, there were substantial reductions in hypertension and elevated waist circumference. We found that a culturally tailored weight management program reduced weight and cardiovascular risk factors for African American women in an urban community. While small, our study suggests that targeted community-based interventions focusing on personal and group wellness have the power to reduce health disparities and improve cardiovascular health for African American women.

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

Co-Designing a Program to Lower Cardiovascular Disease Risk in Midlife Black Women. [2022] Midlife Black women suffer disproportionately from heart disease and stroke in comparison to White women of similar age and demographic. Risk for cardiovascular disease (CVD) and stroke is largely considered to be modifiable yet CVD prevention and awareness campaigns have been less effective among Black women. Decreased awareness of personal CVD risk is associated with delays in the presentation of women to the emergency room or health care providers for symptoms of myocardial infarction. The Midlife Black Women's Stress and Wellness (B-SWELL) program was designed to increase awareness about CVD risk factors, stress, and healthy lifestyle behaviors among midlife Black women. In partnership with an existing Community Research Advisory Board (C-RAB), materials were developed and culturally adapted for the B-SWELL program. Following successful development of the B-SWELL materials, a trial of the B-SWELL program was conducted with a sample of midlife Black women recruited from the community. The program was co-facilitated by members of the C-RAB. We outline the strategies used to successfully co-create and trial the B-SWELL program materials and reflect on the strengths and challenges associated with the development of a culturally tailored heart disease prevention program using community participatory methods.