Lessons Learned in Clinical Research Recruitment of Midlife Latinas During COVID-19.

OBJECTIVE: The purpose of this brief report is to describe lessons learned in recruiting and enrolling midlife Latinas in a pilot study to reduce cardiovascular disease (CVD) risk during the menopause transition. We also discuss strategies implemented to overcome the challenges presented by the novel coronavirus (COVID-19) pandemic. METHODS: Menopausia, Salud y Corazo´n is a two-group (intervention, waitlist control), repeated measures study. The intervention consists of CVD risk education, coping skills training, physical activity, and stress management. Eligible participants are peri- and early postmenopausal Latinas age 40 to 60 years, free of CVD. From August 2020 to October 2021, we screened 110 women recruited from cultural events and health fairs (n = 56), local businesses (n = 24), and snowball sampling (n = 30). Of these, 60 were eligible for inclusion and 41 enrolled. RESULTS: Strategies that contributed to successful recruitment included: a primarily Latina bilingual (English, Spanish) research team; flexibility with location and scheduling of data collection; and multiple modes of communication (ie, mailings, phone calls, and text messages). Additionally, we addressed Latino cultural values such as respeto (respect), familismo (loyalty to family), and confianza (trust). In response to COVID-19, we included virtual recruitment strategies, limited in-person visits, and distributed community resources for COVID-19. CONCLUSION: We have found that despite the challenges presented by COVID-19, midlife Latinas are receptive to clinical research engagement. Researcher flexibility, multiple recruitment modalities, a bilingual research team, and communication strategies that address cultural values are essential elements for the representation of midlife Latinas in research.

A multi-component, community-engaged intervention to reduce cardiovascular disease risk in perimenopausal Latinas: pilot study protocol.

BACKGROUND: Cardiovascular disease (CVD) risk increases substantially during perimenopause. Latinas have a significantly worse CVD risk factor profile than non-Hispanic White women, potentially due to multiple sociocultural and environmental factors. To date, interdisciplinary interventions have not focused on improving nutrition, physical activity, stress management, and biologic CVD risk in perimenopausal Latinas. The purpose of this study is to examine the feasibility and initial efficacy of a multi-component intervention to reduce CVD risk in perimenopausal Latinas. METHODS: This is a two-group, repeated measures experimental study. Eighty perimenopausal Latinas (age 40-55 years) from two community groups will be randomized: one group will complete the intervention; the other will be a wait-list control. The intervention consists of 12-weekly sessions (education, physical activity, stress management, coping skills training), followed by 3 months of continued support, and 6 months of skill maintenance on their own. The primary outcomes include arterial stiffness, blood pressure, lipids, and blood glucose. Secondary outcomes are health behaviors (nutrition, physical activity, sleep, coping strategies), self-efficacy, and other biological factors related to CVD risk (adiposity, C-reactive protein, hair cortisol, vasomotor symptoms). We will assess changes in outcomes from Time 1 (baseline) to Time 2 (6 months) and Time 3 (12 months) using general linear mixed models to test the hypotheses. We will also evaluate the feasibility of the intervention by assessing enrollment and retention rates, barriers, and facilitators to enrollment, intervention fidelity, the suitability of study procedures, and participant satisfaction with the intervention and study protocol. We hypothesize the intervention group will decrease biologic CVD risk and improve health behaviors and self-efficacy significantly more than the wait-list control. DISCUSSION: Results from this study will contribute to knowledge on the feasibility of behavioral interventions, including stress management and coping skills training, which could reduce CVD burden among perimenopausal Latinas. Because Hispanic/Latinos are the largest ethnic minority in the United States (US), progress regarding CVD risk among perimenopausal Latinas may lead to significant improvement in the overall CVD burden in the US. TRIAL REGISTRATION: Prospectively registered, NCT04313751 (03/19/2020), Protocol version 1.0.