Reducing Cardiovascular Disease Risk in Perimenopausal Latinas: Pilot Study of a Multi-Component Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After enrollment and baseline assessment, participants will be randomized to a community site receiving either the intervention or waitlist control.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •heart murmur
- •congenital heart disease
- •family history of sudden death
- •difficulty exercising
- •history of CVD (heart attack, stroke, coronary heart disease)
结局指标
主要结局
Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3
时间窗: 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.
Change in Mean Arterial Stiffness From Baseline (Time 1) to Time 3
时间窗: 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.
Changes in Mean Fasting Lipids (LDL Cholesterol) From Baseline (Time 1) to Time 3
时间窗: 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.
Changes in Mean Fasting Lipids (Total Cholesterol) From Baseline (Time 1) to Time 3
时间窗: 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.
Changes in Mean Fasting Lipids (Triglycerides) From Baseline (Time 1) to Time 3
时间窗: 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.
Changes in Mean Fasting Lipids (HDL Cholesterol) From Baseline (Time 1) to Time 3
时间窗: 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.
Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2
时间窗: 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.
Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3
时间窗: 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.
次要结局
- 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 Weight (Kg) 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 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 Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 2(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(Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months))
- Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months))
- Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months))
- Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3(Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months))
- Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months))
- Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3(Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months))
- Change in Median Eating Self-Efficacy Questionnaire 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))
- Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months))
- Change in Median High-Sensitivity C-Reactive Protein 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))
- Change in Mean Hair Cortisol Levels 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))
- Change in Mean Exercise Self-Efficacy Questionnaire 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))
- Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2(Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) ])
- Change in Mean Sleep Quality Questionnaire 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))
- Number of Eligible Women That Agree to Participate in the Study(Baseline)
- Time for Recruitment(Baseline)
- Mean Proportion of Group Sessions Participants Attend(Time 2 (Intervention completion, approx. 6 months))
- Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3)(Time 2 (Intervention completion, approx. 6 months) and Time 3 (after 6 months with no contact from the study staff, approximately 12 months))
- Proportion of Participants That Attend at Least 80% of the Intervention Session (12-15 Sessions).(Time 2 (Intervention completion, approx. 6 months))
- Number of Participants That Would Recommend the Study to a Friend or Relative.(Time 3 (after 6 months with no contact from the study staff, approximately 12 months))