N/A N=49 Randomized Triple-blind Prevention

Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

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

Bottom Line

View on ClinicalTrials.gov: NCT04313751 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2 — -0.3; -2.4; 1.2; 2.2 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Education, Physical Activity, and Stress Management Program (Behavioral); Wait-list (Other)
Age: Adult · 40+ yrs
Sex: Female
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2	-0.3; -2.4; 1.2; 2.2	—
PRIMARY Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3	2.4; -2.8; -1.0; -1.4	—
PRIMARY Change in Mean Arterial Stiffness From Baseline (Time 1) to Time 3	0.0; -0.3	—
PRIMARY Changes in Mean Fasting Lipids (Total Cholesterol) From Baseline (Time 1) to Time 3	7.6; -13.9	—
PRIMARY Changes in Mean Fasting Lipids (Triglycerides) From Baseline (Time 1) to Time 3	15.4; -30.4	—
PRIMARY Changes in Mean Fasting Lipids (HDL Cholesterol) From Baseline (Time 1) to Time 3	3.89; -4.10	—
PRIMARY Changes in Mean Fasting Lipids (LDL Cholesterol) From Baseline (Time 1) to Time 3	2.9; 5.4	—
PRIMARY Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3	5.0; 9.9	—
SECONDARY Change in Mean Weight (Kg) From Baseline (Time 1) to Time 2	-2.9; -1.6	—
SECONDARY Change in Mean Weight (Kg) From Baseline (Time 1) to Time 3	-2.7; -2.1	—
SECONDARY Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 2	-1.3; -0.2	—
SECONDARY Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 3	-1.3; -0.9	—
SECONDARY Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2	-6.0; -5.4	—
SECONDARY Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3	-2.9; -1.6	—
SECONDARY Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2	0.0; 0.044; 0.038; 0.043; 0.077; -0.044	—
SECONDARY Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3	0.076; 0.043; 0.153; 0.043; 0.115; -0.174	—
SECONDARY Change in Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 2	—	—
SECONDARY Change in Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 3	—	—
SECONDARY Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2	-7.5; -35.0	—
SECONDARY Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3	-11.0; 31.0	—
SECONDARY Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2	-0.5; -2.4	—
SECONDARY Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3	-10.4; -4.9	—
SECONDARY Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2	-2.1; 0.4	—
SECONDARY Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 3	-2.5; -1.5	—
SECONDARY Change in Median High-Sensitivity C-Reactive Protein From Baseline (Time 1) to Time 3	86.6; 272.3	—
SECONDARY Change in Mean Hair Cortisol Levels From Baseline (Time 1) to Time 3	24.29; 13.39	—
SECONDARY Number of Eligible Women That Agree to Participate in the Study	49	—
SECONDARY Time for Recruitment	30; 90	—
SECONDARY Mean Proportion of Group Sessions Participants Attend	0.533	—
SECONDARY Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3)	22; 20; 21; 16	—
SECONDARY Proportion of Participants That Attend at Least 80% of the Intervention Session (12-15 Sessions).	0.26923077	—
SECONDARY Number of Participants That Would Recommend the Study to a Friend or Relative.	20; 15	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04313751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.