Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

University of North Carolina (UNC)

Status: Completed

Conditions: Self Efficacy; Physical Activity; Vascular Stiffness; Health Behavior; Cardiovascular Risk Factor

Treatments: Behavioral: Education, Physical Activity, and Stress Management Program; Other: Wait-list

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04313751

19-2756

K23MD014767 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 40-60 years
• self-identify as Hispanic/Latina
• understand spoken English or Spanish
• perimenopausal or early postmenopausal (menstrual bleeding in the past 3 months, but timing have varied in past year; no menstrual bleeding in the past 3-11 months; last menstrual cycle 12-24 months ago)
• intact uterus and at least one ovary
• not currently pregnant
• no hormone therapy or oral contraceptives in the past 3 months
• consent to join the study

Exclusion criteria

• heart murmur
• congenital heart disease
• family history of sudden death
• difficulty exercising
• history of CVD (heart attack, stroke, coronary heart disease)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups

Education, Physical Activity, and Stress Management Program

Experimental group

Description:

Classes for the intervention group will be run by a bilingual interventionist and will last 120 minutes weekly for 12 weeks and then monthly for 3 months.

Treatment:

Behavioral: Education, Physical Activity, and Stress Management Program

Wait-list Control

Active Comparator group

Description:

Data in the wait-list control group will be collected at the same time intervals as the intervention group. After Time 3 data collection, they will be offered the Phase I intervention (12 weekly sessions).

Treatment:

Other: Wait-list