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.

RCT Entities:   Population Interventions Outcomes