Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

NCT04313751 | Completed Results DMC

• 2 other identifiers: 19-2756K23MD014767
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hispanic/Latina; Menopause; Cardiovascular disease

Outcome Measures

Primary Outcomes (8)

• Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2

  Blood pressure will be measured in the right arm using a digital monitor. Participants will be seated comfortably with feet flat on the floor in a chair with back supported and the right arm resting on a table. The patient should be seated for 3-5 minutes without talking or moving around before recording the first blood pressure reading. Blood pressure will be repeated twice with the average computed. If it is not possible to measure blood pressure in the right arm, the left arm will be used and noted in the participant record.

  Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)

• Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3

  Blood pressure will be measured in the right arm using a digital monitor. Participants will be seated comfortably with feet flat on the floor in a chair with back supported and the right arm resting on a table. The patient should be seated for 3-5 minutes without talking or moving around before recording the first blood pressure reading. Blood pressure will be repeated twice with the average computed. If it is not possible to measure blood pressure in the right arm, the left arm will be used and noted in the participant record.

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)

• Change in Mean Arterial Stiffness From Baseline (Time 1) to Time 3

  Arterial stiffness will be measured by carotid-femoral pulse wave velocity and pulse wave analysis using the Vicorder® System (Skidmore Medical, Bristol, UK). Pulse wave velocity will be repeated twice with the average computed.

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)

• Changes in Mean Fasting Lipids (Total Cholesterol) From Baseline (Time 1) to Time 3

  Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc™ pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)

• Changes in Mean Fasting Lipids (Triglycerides) From Baseline (Time 1) to Time 3

  Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)

• Changes in Mean Fasting Lipids (HDL Cholesterol) From Baseline (Time 1) to Time 3

  Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)]

• Changes in Mean Fasting Lipids (LDL Cholesterol) From Baseline (Time 1) to Time 3

  LDL Cholesterol will be computed at Time 1 and Time 3. Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)

• Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3

  Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)

Secondary Outcomes (24)

• Change in Mean Weight (Kg) From Baseline (Time 1) to Time 2

  Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)

• Change in Mean Weight (Kg) From Baseline (Time 1) to Time 3

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)

• Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 2

  Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)

• Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 3

  Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)

• Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2

  Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)

Other Outcomes (2)

• Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 2

  Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)

• Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 3

  Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)

Study Arms (2)

Education, Physical Activity, and Stress Management Program

EXPERIMENTAL

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.

Behavioral: Education, Physical Activity, and Stress Management Program

Wait-list Control

ACTIVE COMPARATOR

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).

Other: Wait-list

Interventions

Education, Physical Activity, and Stress Management Program BEHAVIORAL

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.

Education, Physical Activity, and Stress Management Program

Wait-list OTHER

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.

Wait-list Control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

• Cortes YI, Harris LK, Cazales A, Marginean V, Long C, Woods-Giscombe CL, Perreira KM. Feasibility and acceptability of Menopausia, Salud, Corazon (Menopause, Health, Heart): a pilot randomized trial to reduce cardiovascular disease risk in midlife Latinas. Menopause. 2026 Feb 3. doi: 10.1097/GME.0000000000002718. Online ahead of print.

  PMID: 41632258 DERIVED

• 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.

  PMID: 35796561 DERIVED

• 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.

  PMID: 33407947 DERIVED

MeSH Terms

Conditions

Health Behavior; Motor Activity; Cardiovascular Diseases

Interventions

Educational Status; Exercise; Waiting Lists

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Appointments and Schedules; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Yamnia Cortes, PhD, MPH, RN
• Organization: University of North Carolina at Chapel Hill

yamnia-cortes@uiowa.edu

319-335-1131

Study Officials

• Yamnia I Cortes, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After enrollment and baseline assessment, participants will be randomized to a community site receiving either the intervention or waitlist control.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: June 30, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the close of the study and after the main data from the study has been published.
• Access Criteria: Contact Dr. Yamnia I. Cortes at yicortes@email.unc.edu

Locations

US (1)