Cardiovascular Risk Factor, Health Behavior, Physical Activity, Self Efficacy, Vascular Stiffness
Conditions
Keywords
Hispanic/Latina, Menopause, Cardiovascular disease
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.
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.
Interventions
BEHAVIORALEducation, Physical Activity, and Stress Management Program
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.
OTHERWait-list
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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
After enrollment and baseline assessment, participants will be randomized to a community site receiving either the intervention or waitlist control.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3 | 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 (LDL Cholesterol) From Baseline (Time 1) to Time 3 | 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. |
| Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2 | 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. |
| Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3 | 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 | 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 (Total Cholesterol) From Baseline (Time 1) to Time 3 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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) | 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. |
| 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) | 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. |
| Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2 | 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. |
| 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) | 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. |
| Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2 | 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. |
| 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) | 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. |
| Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2 | 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. |
| 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) | 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. |
| 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) | 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. |
| Number of Eligible Women That Agree to Participate in the Study | 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. |
| Time for Recruitment | Baseline | This will be defined as time (days) from initial contact with research staff to randomization into the study. |
| Mean Proportion of Group Sessions Participants Attend | 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. |
| 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) | The retention rate will be defined as the percentage of participants remaining in the study at post-intervention and at study completion. |
| Proportion of Participants That Attend at Least 80% of the Intervention Session (12-15 Sessions). | Time 2 (Intervention completion, approx. 6 months) | A Research Assistant will assess fidelity of the intervention fidelity by keeping an attendance log. |
| 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) | 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? |
| 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) | 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. |
| Change in Mean Weight (Kg) From Baseline (Time 1) to Time 2 | 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. |
| 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) | 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. |
| Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 2 | 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. |
| 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) | Participant weight and height will be used to calculate BMI. Calculation of BMI in kilograms divided by meters squared. |
| Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2 | 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. |
| 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) | Waist circumference will be measured at the level of the umbilicus in centimeters using a measuring tape. |
| 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 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.. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | Participants will report experiencing any vasomotor symptoms (night sweats, hot flashes) in the past two weeks |
| 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) | Participants will report experiencing any vasomotor symptoms (night sweats, hot flashes) in the past two weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Education, Physical Activity, and Stress Management Program 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.
Education, Physical Activity, and Stress Management Program: 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. | 26 |
| Wait-list Control 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).
Wait-list: 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. | 23 |
| Total | 49 |
Baseline characteristics
| Characteristic | Education, Physical Activity, and Stress Management Program | Total | Wait-list Control |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 4.2 | 47.10 years STANDARD_DEVIATION 4.5 | 47.7 years STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 49 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants | 49 Participants | 23 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 26 Participants | 49 Participants | 23 Participants |
| Sex: Female, Male Female | 26 Participants | 49 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 23 |
| other Total, other adverse events | 0 / 26 | 0 / 23 |
| serious Total, serious adverse events | 0 / 26 | 0 / 23 |
Outcome results
Primary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Arterial Stiffness From Baseline (Time 1) to Time 3 | 0.0 meters per second (m/s) | Standard Deviation 0.1 |
| Wait-list Control | Change in Mean Arterial Stiffness From Baseline (Time 1) to Time 3 | -0.3 meters per second (m/s) | Standard Deviation 1.1 |
Primary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3 | Systolic | 2.4 mmHg | Standard Deviation 3.3 |
| Education, Physical Activity, and Stress Management Program | Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3 | Diastolic | -1.0 mmHg | Standard Deviation 0.8 |
| Wait-list Control | Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3 | Systolic | -2.8 mmHg | Standard Deviation 1.4 |
| Wait-list Control | Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3 | Diastolic | -1.4 mmHg | Standard Deviation 1.4 |
Primary
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.
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2 | Systolic | -0.3 mmHg | Standard Deviation 2.7 |
| Education, Physical Activity, and Stress Management Program | Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2 | Diastolic | 1.2 mmHg | Standard Deviation 2 |
| Wait-list Control | Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2 | Systolic | -2.4 mmHg | Standard Deviation 4.1 |
| Wait-list Control | Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2 | Diastolic | 2.2 mmHg | Standard Deviation 2.7 |
Primary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3 | 5.0 mg/dL | Standard Deviation 2.3 |
| Wait-list Control | Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3 | 9.9 mg/dL | Standard Deviation 37.9 |
Primary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Changes in Mean Fasting Lipids (HDL Cholesterol) From Baseline (Time 1) to Time 3 | 3.89 mg/dL | Standard Deviation 3.7 |
| Wait-list Control | Changes in Mean Fasting Lipids (HDL Cholesterol) From Baseline (Time 1) to Time 3 | -4.10 mg/dL | Standard Deviation 2.2 |
Primary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Changes in Mean Fasting Lipids (LDL Cholesterol) From Baseline (Time 1) to Time 3 | 2.9 mg/dL | Standard Deviation 9.8 |
| Wait-list Control | Changes in Mean Fasting Lipids (LDL Cholesterol) From Baseline (Time 1) to Time 3 | 5.4 mg/dL | Standard Deviation 13.9 |
Primary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Changes in Mean Fasting Lipids (Total Cholesterol) From Baseline (Time 1) to Time 3 | 7.6 mg/dL | Standard Deviation 11.7 |
| Wait-list Control | Changes in Mean Fasting Lipids (Total Cholesterol) From Baseline (Time 1) to Time 3 | -13.9 mg/dL | Standard Deviation 2.2 |
Primary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Changes in Mean Fasting Lipids (Triglycerides) From Baseline (Time 1) to Time 3 | 15.4 mg/dL | Standard Deviation 23.3 |
| Wait-list Control | Changes in Mean Fasting Lipids (Triglycerides) From Baseline (Time 1) to Time 3 | -30.4 mg/dL | Standard Deviation 16 |
Secondary
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.
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Population: No data were collected for this outcome. Due to the COVID-19 pandemic many of the community-based organizations that were going to serve as pick-up and drop-off for the accelerometers were closed. In addition, the funding source for purchasing accelerometers was lost.
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Population: No data were collected for this outcome. Due to the COVID-19 pandemic many of the community-based organizations that were going to serve as pick-up and drop-off for the accelerometers were closed. In addition, the funding source for purchasing accelerometers was lost.
Secondary
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.
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2 | -6.0 centimeters (cm) | Standard Deviation 4.6 |
| Wait-list Control | Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2 | -5.4 centimeters (cm) | Standard Deviation 1.4 |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3 | -2.9 centimeters (cm) | Standard Deviation 0.4 |
| Wait-list Control | Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3 | -1.6 centimeters (cm) | Standard Deviation 1.2 |
Secondary
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.
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 2 | -1.3 Kg/m^2 | Standard Deviation 5.4 |
| Wait-list Control | Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 2 | -0.2 Kg/m^2 | Standard Deviation 5.5 |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 3 | -1.3 Kg/m^2 | Standard Deviation 0.3 |
| Wait-list Control | Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 3 | -0.9 Kg/m^2 | Standard Deviation 5.9 |
Secondary
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.
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2 | -0.5 score on a scale | Standard Deviation 2.1 |
| Wait-list Control | Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2 | -2.4 score on a scale | Standard Deviation 2.3 |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3 | -10.4 score on a scale | Standard Deviation 3.3 |
| Wait-list Control | Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3 | -4.9 score on a scale | Standard Deviation 3 |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Hair Cortisol Levels From Baseline (Time 1) to Time 3 | 24.29 pg/mg | Standard Deviation 89.05 |
| Wait-list Control | Change in Mean Hair Cortisol Levels From Baseline (Time 1) to Time 3 | 13.39 pg/mg | Standard Deviation 29.01 |
Secondary
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.
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) ]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2 | -2.1 score on a scale | Standard Deviation 4.1 |
| Wait-list Control | Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2 | 0.4 score on a scale | Standard Deviation 4.9 |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 3 | -2.5 score on a scale | Standard Deviation 4.1 |
| Wait-list Control | Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 3 | -1.5 score on a scale | Standard Deviation 4.9 |
Secondary
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.
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Weight (Kg) From Baseline (Time 1) to Time 2 | -2.9 Kg | Standard Deviation 1.9 |
| Wait-list Control | Change in Mean Weight (Kg) From Baseline (Time 1) to Time 2 | -1.6 Kg | Standard Deviation 0.7 |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Mean Weight (Kg) From Baseline (Time 1) to Time 3 | -2.7 Kg | Standard Deviation 1.4 |
| Wait-list Control | Change in Mean Weight (Kg) From Baseline (Time 1) to Time 3 | -2.1 Kg | Standard Deviation 0.3 |
Secondary
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.
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2 | -7.5 score on a scale |
| Wait-list Control | Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2 | -35.0 score on a scale |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3 | -11.0 score on a scale |
| Wait-list Control | Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3 | 31.0 score on a scale |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Median High-Sensitivity C-Reactive Protein From Baseline (Time 1) to Time 3 | 86.6 ng/mL |
| Wait-list Control | Change in Median High-Sensitivity C-Reactive Protein From Baseline (Time 1) to Time 3 | 272.3 ng/mL |
Secondary
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..
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2 | Fruit | 0.0 proportion of participants |
| Education, Physical Activity, and Stress Management Program | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2 | Vegetable | 0.038 proportion of participants |
| Education, Physical Activity, and Stress Management Program | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2 | Fish | 0.077 proportion of participants |
| Wait-list Control | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2 | Fruit | 0.044 proportion of participants |
| Wait-list Control | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2 | Vegetable | 0.043 proportion of participants |
| Wait-list Control | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2 | Fish | -0.044 proportion of participants |
Secondary
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.
Time frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3 | Fruit | 0.076 proportion of participants |
| Education, Physical Activity, and Stress Management Program | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3 | Vegetable | 0.153 proportion of participants |
| Education, Physical Activity, and Stress Management Program | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3 | Fish | 0.115 proportion of participants |
| Wait-list Control | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3 | Fruit | 0.043 proportion of participants |
| Wait-list Control | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3 | Vegetable | 0.043 proportion of participants |
| Wait-list Control | Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3 | Fish | -0.174 proportion of participants |
Secondary
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.
Time frame: Time 2 (Intervention completion, approx. 6 months)
Population: This only applies to the intervention arm because the Wait-list Control arm did not have any sessions to attend during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Mean Proportion of Group Sessions Participants Attend | 0.533 proportion of sessions attended | Standard Deviation 1 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Number of Eligible Women That Agree to Participate in the Study | 49 Participants |
Secondary
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.
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Education, Physical Activity, and Stress Management Program | Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3) | Post-intervention (Time 2) | 22 Participants |
| Education, Physical Activity, and Stress Management Program | Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3) | Study Completion (Time 3) | 21 Participants |
| Wait-list Control | Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3) | Post-intervention (Time 2) | 20 Participants |
| Wait-list Control | Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3) | Study Completion (Time 3) | 16 Participants |
Secondary
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?
Time frame: Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Number of Participants That Would Recommend the Study to a Friend or Relative. | 20 Participants |
| Wait-list Control | Number of Participants That Would Recommend the Study to a Friend or Relative. | 15 Participants |
Secondary
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.
Time frame: Time 2 (Intervention completion, approx. 6 months)
Population: This is outcome is only applicable to the intervention group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Proportion of Participants That Attend at Least 80% of the Intervention Session (12-15 Sessions). | 0.26923077 proportion of participants |
Secondary
Time for Recruitment
This will be defined as time (days) from initial contact with research staff to randomization into the study.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Time for Recruitment | 30 days |
| Wait-list Control | Time for Recruitment | 90 days |
Other Pre-specified
Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 2
Participants will report experiencing any vasomotor symptoms (night sweats, hot flashes) in the past two weeks
Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 2 | -0.193 proportion of participants |
| Wait-list Control | Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 2 | -0.305 proportion of participants |
Other Pre-specified
Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 3
Participants will report experiencing any vasomotor symptoms (night sweats, hot flashes) in the past two weeks.
Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Education, Physical Activity, and Stress Management Program | Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 3 | -0.154 proportion of participants |
| Wait-list Control | Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 3 | -0.261 proportion of participants |