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

Yamnia I Cortés,Cheryl Woods Giscombé,Lymarí Santíago,Lee Stoner,Alison Stuebe,Mayra Duran,Latesha K Harris,Krista M Perreira,Diane C Berry,Jamie Crandell

doi:10.1186/s40814-020-00756-1

Yamnia I Cortés, Cheryl Woods Giscombé + Show 8 more

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https://doi.org/10.1186/s40814-020-00756-1

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Abstract

BackgroundCardiovascular 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.MethodsThis 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.DiscussionResults 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 registrationProspectively registered, NCT04313751 (03/19/2020), Protocol version 1.0

Highlights

Cardiovascular disease (CVD) risk increases substantially during perimenopause
Despite being at greater risk for CVD, only 34% of Latinas are aware that CVD is the leading cause of death in women [5]
Perimenopause is marked by dramatic changes in sex hormone levels, which may adversely affect CVD risk factors [8, 113]

Summary

Introduction

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. Hispanic women (Latinas) in the United States (US) have a significantly worse CVD risk factor profile than non-Hispanic White women, including higher rates of diabetes, uncontrolled hypertension, and metabolic syndrome [2, 3]. While evidence-based guidelines promote healthy lifestyle behaviors to reduce CVD risk [6], Latinas remain considerably less likely to meet physical activity and dietary guidelines than non-Hispanic White women, during midlife [7]. Among Latinas, the Hispanic Community Health Study/Study of Latinos found that the age-adjusted prevalence of metabolic syndrome, a risk factor for CVD [14], ranged from 35 to 55% in women age 40–59 years, compared to 10–26% in women less than 40 years [15]. Menopause is associated with elevated levels of proinflammatory cytokines [19, 20] and C-reactive protein [21], thought to play a role in the development of arterial stiffness [22, 23]

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