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Cardiovascular Risk FactorNCT04313751

Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

A study testing Education, Physical Activity, and Stress Management Program and Wait-list in people with Cardiovascular Risk Factor and Health Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
What is being tested?
Education, Physical Activity, and Stress Management Program and Wait-list
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
30 Jun 2020to 30 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Education, Physical Activity, and Stress Management Program, Wait-list
Keywords
Hispanic/Latina, Menopause, Cardiovascular disease
Medical subject headings
Health Behavior, Motor Activity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education, Physical Activity, and Stress Management ProgramBehavioural

    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.

  • Wait-listOther

    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.

Study groups in NCT04313751
Study groupRoleWhat they receive
Education, Physical Activity, and Stress Management ProgramExperimentalClasses 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.
Receives: Behavioral: Education, Physical Activity, and Stress Management Program
Wait-list ControlActive comparatorData 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).
Receives: Other: Wait-list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

Secondary outcomes (24)

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

    Weight will be measured twice using a digital scale placed on a hard, flat surface. The measurement will be recorded to the nearest 0.1-kg.

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

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

    Weight will be measured twice using a digital scale placed on a hard, flat surface. The measurement will be recorded to the nearest 0.1-kg.

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

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

    Participant weight and height will be used to calculate BMI. Calculation of BMI in kilograms divided by meters squared.

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

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

    Participant weight and height will be used to calculate BMI. Calculation of BMI in kilograms divided by meters squared.

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

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

    Waist circumference will be measured at the level of the umbilicus in centimeters using a measuring tape.

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

  6. Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3

    Waist circumference will be measured at the level of the umbilicus in centimeters using a measuring tape.

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

  7. Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2

    Change in proportion of participants meeting American Heart Association-recommended intake of each of the following: fruits, vegetables, and fish based on completing the Food Behavior Checklist. The Food Behavior Checklist asks participants to indicate the number of daily servings consumed for each category..

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

  8. Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3

    Change in proportion of participants meeting American Heart Association-recommended intake of each of the following: fruits, vegetables, and fish based on completing the Food Behavior Checklist. The Food Behavior Checklist asks participants to indicate the number of daily servings consumed for each category.

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

  9. Change in Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 2

    The participant will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. The proportion of participants across categories will be reported.

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

  10. Change in Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 3

    The participant will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. The proportion of participants across categories will be reported.

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

  11. Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2

    This is a 25-item questionnaire asking how much difficulty the participant has with controlling her eating in social situations and every day. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score (0-175). A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.

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

  12. Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3

    This is a 25-item questionnaire asking how much difficulty the participant has with controlling her eating in social situations and every day. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score (0-175). A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.

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

  13. Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2

    This is a 9-item questionnaire asking how much confidence the participant has doing particular exercises. The range of scores go from 0 to 10 with 0 being she is not confident at all (low self-efficacy) and and 10 being that she is certain she can do it (high self-efficacy). The numbers are summed for a total score (0-90) with higher scores indicating greater exercise self-efficacy.

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

  14. Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3

    This is a 9-item questionnaire asking how much confidence the participant has doing particular exercises. The range of scores go from 0 to 10 with 0 being she is not confident at all (low self-efficacy) and and 10 being that she is certain she can do it (high self-efficacy). The numbers are summed for a total score (0-90) with higher scores indicating greater exercise self-efficacy.

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

  15. Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2

    This is a 4-item question questionnaire previously used in studies during the menopause transition. Each question is scored from 0 to 4, with 0 being indicating no difficulty with sleep in the past two weeks and 4 indicating five or more times a week of difficulty sleeping. The numbers are summed for a total score (0-16). A lower number indicates that the participant does not have difficulty sleeping and a higher number means that the participant has a lot of difficulty sleeping.

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

  16. Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 3

    This is a 4-item question questionnaire previously used in studies during the menopause transition. Each question is scored from 0 to 4, with 0 being indicating no difficulty with sleep in the past two weeks and 4 indicating five or more times a week of difficulty sleeping. The numbers are summed for a total score (0-16). A lower number indicates that the participant does not have difficulty sleeping and a higher number means that the participant has a lot of difficulty sleeping.

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

  17. Change in Median High-Sensitivity C-Reactive Protein From Baseline (Time 1) to Time 3

    Serum high-sensitivity C-reactive protein levels will by obtained by from a fasting blood sample and at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.

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

  18. Change in Mean Hair Cortisol Levels From Baseline (Time 1) to Time 3

    Cortisol will be obtained from hair samples and analyzed using a standard laboratory protocol at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.

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

  19. Number of Eligible Women That Agree to Participate in the Study

    This will be defined as a number of women that agree to participate in the study out of the total women screened for the study.

    Measured: Baseline

  20. Time for Recruitment

    This will be defined as time (days) from initial contact with research staff to randomization into the study.

    Measured: Baseline

  21. Mean Proportion of Group Sessions Participants Attend

    The attendance rate will be defined as the proportion of group sessions the participant attends.The mean proportion of sessions that participants attended out of the total of 15 sessions offered is reported.

    Measured: Time 2 (Intervention completion, approx. 6 months)

  22. Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3)

    The retention rate will be defined as the percentage of participants remaining in the study at post-intervention and at study completion.

    Measured: Time 2 (Intervention completion, approx. 6 months) and Time 3 (after 6 months with no contact from the study staff, approximately 12 months)

  23. Proportion of Participants That Attend at Least 80% of the Intervention Session (12-15 Sessions).

    A Research Assistant will assess fidelity of the intervention fidelity by keeping an attendance log.

    Measured: Time 2 (Intervention completion, approx. 6 months)

  24. Number of Participants That Would Recommend the Study to a Friend or Relative.

    Participants will be asked: "If a friend or relative were to be asked to take part in the study, how likely would you be to recommend that they participate?"

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2020
  2. Study start30 Jun 2020
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04313751
Sponsor's protocol ID
19-2756
Other IDs
K23MD014767
Status last verified
Apr 2024
First submitted
16 Mar 2020
Last updated
20 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • Long CA, Marginean V, Harris LK, Zhang C, Cortes YI. Are psychosocial factors and menopause symptoms related to hair cortisol concentrations among midlife Latinas? Results from the Menopausia, Salud, Corazon pilot study. Compr Psychoneuroendocrinol. 2026 Jun 23;27:100359. doi: 10.1016/j.cpnec.2026.100359. eCollection 2026 Aug.

    PubMed 42388907

  • 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 Jun 1;33(6):641-652. doi: 10.1097/GME.0000000000002718.

    PubMed 41632258

  • 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.

    PubMed 35796561

  • 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.

    PubMed 33407947

Questions about this trial

What is this clinical trial studying?

A study testing Education, Physical Activity, and Stress Management Program and Wait-list in people with Cardiovascular Risk Factor and Health Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2 (time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04313751, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

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