Clinical trial NCT04313751: Reducing Cardiovascular Disease Risk in Perimenopausal Latinas
Official title: Reducing Cardiovascular Disease Risk in Perimenopausal Latinas: Pilot Study of a Multi-Component Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Health Behavior
Physical Activity
Self Efficacy
Vascular Stiffness
Keywords: Hispanic/Latina
Menopause
Cardiovascular disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-03-18
Enrollment: 49
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Change in Mean Arterial Stiffness From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Changes in Mean Fasting Lipids (Total Cholesterol) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Changes in Mean Fasting Lipids (Triglycerides) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Changes in Mean Fasting Lipids (HDL Cholesterol) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)]
measure: Changes in Mean Fasting Lipids (LDL Cholesterol) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Secondary outcomes:
measure: Change in Mean Weight (Kg) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Mean Weight (Kg) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
measure: Change in Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
measure: Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
measure: Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
measure: Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) ]
measure: Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
measure: Change in Median High-Sensitivity C-Reactive Protein From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
measure: Change in Mean Hair Cortisol Levels From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
measure: Number of Eligible Women That Agree to Participate in the Study
timeFrame: Baseline
measure: Time for Recruitment
timeFrame: Baseline
measure: Mean Proportion of Group Sessions Participants Attend
timeFrame: Time 2 (Intervention completion, approx. 6 months)
measure: Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3)
timeFrame: Time 2 (Intervention completion, approx. 6 months) and Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
measure: Proportion of Participants That Attend at Least 80% of the Intervention Session (12-15 Sessions).
timeFrame: Time 2 (Intervention completion, approx. 6 months)
measure: Number of Participants That Would Recommend the Study to a Friend or Relative.
timeFrame: Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Other outcomes:
measure: Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 2
timeFrame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
measure: Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 3
timeFrame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Yamnia I Cortes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cortes YI, Duran M, Marginean V, Harris LK, Cazales A, Santiago L, Mislan MD, Perreira KM. Lessons Learned in Clinical Research Recruitment of Midlife Latinas During COVID-19. Menopause. 2022 Jul 1;29(7):883-888. doi: 10.1097/GME.0000000000001983.
citation: Cortes YI, Berry DC, Perreira KM, Stuebe A, Stoner L, Giscombe CW, Crandell J, Santiago L, Harris LK, Duran M. A multi-component, community-engaged intervention to reduce cardiovascular disease risk in perimenopausal Latinas: pilot study protocol. Pilot Feasibility Stud. 2021 Jan 6;7(1):10. doi: 10.1186/s40814-020-00756-1.