NCT04313751

Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

Reducing Cardiovascular Disease Risk in Perimenopausal Latinas: Pilot Study of a Multi-Component Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to pilot test a 12-week behavioral intervention among perimenopausal Latinas (age 40-55 years) that integrates evidence-based education with physical activity, stress management, and coping skills training to: 1) reduce cardiovascular disease (CVD) risk factors and arterial stiffness; 2) improve nutrition, physical activity, and sleep behaviors; and 3) improve stress management, coping strategies, and self-efficacy. This study will recruit participants from two community groups: one group will be randomly assigned to complete the intervention; the other will be a wait-list control.

Detailed description

While CVD mortality is the leading cause of death in the United States, large racial/ethnic disparities in cardiovascular health exist between Latinas and non-Hispanic populations. Risk of CVD increases significantly for women following menopause. There are substantial increases in CVD risk factors during perimenopause, specifically, perimenopausal women exhibit greater visceral adipose tissue, fasting glucose, total cholesterol, and systolic blood pressure, compared to premenopausal women. Although behavioral intervention research targeting CVD risk during perimenopause emerged over the past decade, no studies were designed to decrease biological CVD risk among perimenopausal Latinas. This study will recruit perimenopausal Latinas (age 40-55 years) from two community groups: one group will be randomly assigned to complete the intervention; the other will be a wait-list control. This intervention has 3 phases: 12 weekly sessions (Phase I: education, physical activity, stress management, coping skills training) followed by 3 monthly sessions of continued support (Phase II); and finally 6 months of skill maintenance on their own (Phase III). Data will be collected at Time 1 (0 months \[baseline\]), Time 2 (6 months \[completion of the intervention\]) and Time 3 (12 months \[after 6 months of maintenance on own\]). Data collected will include biological CVD risk factors and arterial stiffness (primary outcomes: blood pressure, lipid profile, blood glucose, carotid-femoral pulse wave velocity). Secondary outcomes will include health behaviors and self-efficacy (Food Behavior Checklist, 7 day Accelerometer, Sleep Quality Scale, Eating Self-Efficacy Scale, Exercise Self-Efficacy Scale) and other biological factors related to CVD risk (waist circumference, weight, body mass index \[BMI\], C-reactive protein, hair cortisol). The investigators will also evaluate the feasibility of the intervention (e.g., enrollment and retention rates, barriers and facilitators to enrollment, intervention fidelity, suitability of study procedures and outcome measures, and participant satisfaction with the intervention and study protocol). The knowledge to be gained from this pilot study may provide a foundation for extending this intervention to a larger efficacy trial. This research holds potential to accelerate greatly the acquisition of knowledge related to CVD risk among perimenopausal Latinas, and the impact of behavioral interventions to reduce CVD risk in this underserved population.

Conditions

• Cardiovascular Risk Factor
• Health Behavior
• Physical Activity
• Self Efficacy
• Vascular Stiffness

Interventions

Type	Name	Description
BEHAVIORAL	Education, Physical Activity, and Stress Management Program	Twelve weekly classes for one hour focused on CVD risk factor education using the Su Corazón Su Vida curriculum and coping skills training followed by a 45 minute exercise class and 15 minute stress management session. Then they will return for one hour for continued support, a forty-five minute exercise class, and fifteen minute stress management session.
OTHER	Wait-list	The wait-list control group will receive 12 weekly one hour education and coping skills training sessions followed by a 45 minute exercise class and a 15 minute stress management session.

Timeline

• Start date: 2020-06-30
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-03-18
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

1 site across 1 country: United States