Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Risk Factor, Health Behavior, Physical Activity, Self Efficacy, Vascular Stiffness

Intervention / Treatment
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* Behavioral: Education, Physical Activity, and Stress Management Program
* Other: Wait-list


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education, Physical Activity, and Stress Management Program<br>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<br>* 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.<br>|
| Active Comparator: Wait-list Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean (or Median) 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 (or Median) 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 (or Median) 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 (or Median) 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 (or Median) 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 (or Median) 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 (or Median) Fasting Lipids (LDL Cholesterol) from Baseline (Time 1) to Time 3 | LDL Cholesterol will be computed at Time 1 and Time 3 with the Friedwald equation: LDL cholesterol (mg/dL) = Total Cholesterol - HDL Cholesterol - (Triglycerides/5) | Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months) | 
| Changes in Mean (or Median) 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean (or Median) 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. | Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) | 
| Change in Mean (or Median) 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. | Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months) | 
| Change in Mean (or Median) Body Mass Index (BMI) from Baseline (Time 1) to Time 2 | Calculation of BMI in kilograms divided by meters squared. | Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) | 
| Change in Mean (or Median) Body Mass Index (BMI) from Baseline (Time 1) to Time 3 | Calculation of BMI in kilograms divided by meters squared. | Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months) | 
| Change in Mean (or Median) Adiposity (Waist Circumference) from Baseline (Time 1) to Time 2 | Waist circumference will be measured in centimeters using a measuring tape. | Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) | 
| Change in Mean (or Median) Adiposity (Waist Circumference) from Baseline (Time 1) to Time 3 | Waist circumference will be measured in centimeters using a measuring tape. | Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months) | 
| Change in Proportion of Health Behaviors (Food Behavior Checklist) from Baseline (Time 1) to Time 2 | There are 16 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice. The proportion of healthy food behavior on the Checklist will be reported (e.g, 0, 1-5, 6-10, >10). | Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) | 
| Change in Proportion of Health Behaviors (Food Behavior Checklist) from Baseline (Time 1) to Time 3 | There are 16 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice. The proportion of healthy food behavior on the Checklist will be reported (e.g, 0, 1-5, 6-10, >10). | Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months) | 
| 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. | Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) | 
| 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. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months) | 
| Change in Mean (or 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. | Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) | 
| Change in Mean (or 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. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months) | 
| Change in Mean (or Median) Exercise Self-Efficacy Questionnaire from Baseline (Time 1) to Time 2 | This is a 18-item questionnaire asking how much difficulty the participant has with exercise. The range of scores go from 1 to 10 with 1 being she cannot do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score (0-90). A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the participant is more certain she can exercise. | Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) | 
| Change in Mean (or Median) Exercise Self-Efficacy Questionnaire from Baseline (Time 1) to Time 3 | This is a 18-item questionnaire asking how much difficulty the participant has with exercise. The range of scores go from 1 to 10 with 1 being she cannot do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score (0-90). A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the participant is more certain she can exercise. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months) | 
| Change in Mean (or Median) 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. | Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) ] | 
| Change in Mean (or Median) 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. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months) | 
| Change in Mean (or 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. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months) | 
| Change in Mean (or Median) 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. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months) | 
| Percentage of Eligible Women that Agree to Participate in the Study | This will be defined as a percentage of women that agree to participate in the study out of the women screened for the study. | Baseline | 
| Time for Recruitment | This will be defined as time (days) from initial contact with research staff to randomization into the study. | Baseline | 
| Proportion of Group Sessions Participants Attend | The attendance rate will be defined as the proportion of group sessions the participant attends. | Time 2 (Intervention completion, approx. 6 months) | 
| Proportion 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. | Time 2 (Intervention completion, approx. 6 months) and Time 3 (after 6 months with no contact from the study staff, approximately 12 months) | 
| Intervention Fidelity | The Lead Research Assistant will assess fidelity of the intervention fidelity by observing intervention sessions and evaluating if the interventionists deliver >80% of the protocol content (yes/no). | Time 2 (Intervention completion, approx. 6 months) | 
| Program Evaluation Questionnaire - Overall Program | Participants will also be asked to respond to open-ended questions about the overall study. These questions will assess the most favorable aspects, least favorable aspects, and areas of improvements. Responses will be coded using a variation of the long table approach emphasizing frequency, specificity, emotion, and extensiveness. Codes will be examined to identify themes. | Time 3 (after 6 months with no contact from the study staff, approximately 12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hispanic/Latina, Menopause, Cardiovascular disease