Community-engaged protocol for the modified B-SWELL program randomized control pilot trial

BACKGROUND Midlife Black women experience disproportionately high rates of cardiovascular morbidity and mortality. Evidence supports the use of culturally tailored interventions and community engagement to reduce health disparities in this population. In response, the Midlife Black Women's Stress Reduction and Wellness program (B-SWELL) was co-developed with midlife Black women to address cardiovascular risks and promote healthier lifestyle behaviors. OBJECTIVE This study aims to: (1) Refine the B-SWELL program to enhance sustainability, update outcome metrics in alignment with American Heart Association guidelines, and integrate findings from a prior feasibility trial; and (2) Conduct a randomized controlled pilot trial of the modified B-SWELL program to assess trends in primary and secondary outcomes and explore the preferences of midlife Black women participating in clinical research. METHODS Program refinements were guided by a community-engaged approach. The randomized controlled pilot trial compares the modified B-SWELL intervention with an attention control condition. Midlife Black women from the community will be recruited for participation. The primary outcome is cardiovascular health; secondary outcomes include depressive symptoms, unhealthy days, sleep quality, perceived general health, and symptom burden. STUDY PROGRESS Objectives 1 and 2 have been completed. Although the final sample did not reach the target of 64 participants, five cohorts, each comprised of an intervention group and an attention control group, completed the trial with only 9% attrition. CONCLUSIONS The B-SWELL modifications highlight the value of culturally tailored, community-engaged approaches in addressing persistent cardiovascular health disparities among midlife Black women. TRIAL REGISTRATION Clinicaltrials.gov Registration Number: NCT06707636.