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Completed

NCT Number: NCT04313751

Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

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.

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Key information

Conditions

Cardiovascular Risk Factor Behavior Cardiovascular Diseases Health Behavior Motor Activity Physical Activity Self Efficacy Vascular Stiffness

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    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..

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

    Time frame: Baseline

    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.

  20. Time for Recruitment

    Time frame: Baseline

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

  21. Mean Proportion of Group Sessions Participants Attend

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

    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.

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

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

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

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

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

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

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

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

    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?"

Other outcomes

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

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

    Participants will report experiencing any vasomotor symptoms (night sweats, hot flashes) in the past two weeks

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

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

    Participants will report experiencing any vasomotor symptoms (night sweats, hot flashes) in the past two weeks.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2020
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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