Trial Outcomes & Findings for Reducing Cardiovascular Disease Risk in Perimenopausal Latinas (NCT NCT04313751)
NCT ID: NCT04313751
Last Updated: 2024-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
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 cardiovascular disease (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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
21
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Cardiovascular Disease Risk in Perimenopausal Latinas
Baseline characteristics by cohort
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 4.20 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 4.70 • n=7 Participants
|
47.10 years
STANDARD_DEVIATION 4.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
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
|
-2.4 mmHg
Standard Deviation 4.1
|
|
Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2
Diastolic
|
1.2 mmHg
Standard Deviation 2.0
|
2.2 mmHg
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3
Systolic
|
2.4 mmHg
Standard Deviation 3.3
|
-2.8 mmHg
Standard Deviation 1.4
|
|
Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3
Diastolic
|
-1.0 mmHg
Standard Deviation 0.8
|
-1.4 mmHg
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Mean Arterial Stiffness From Baseline (Time 1) to Time 3
|
0.0 meters per second (m/s)
Standard Deviation 0.1
|
-0.3 meters per second (m/s)
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Changes in Mean Fasting Lipids (Total Cholesterol) From Baseline (Time 1) to Time 3
|
7.6 mg/dL
Standard Deviation 11.7
|
-13.9 mg/dL
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Changes in Mean Fasting Lipids (Triglycerides) From Baseline (Time 1) to Time 3
|
15.4 mg/dL
Standard Deviation 23.3
|
-30.4 mg/dL
Standard Deviation 16.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Changes in Mean Fasting Lipids (HDL Cholesterol) From Baseline (Time 1) to Time 3
|
3.89 mg/dL
Standard Deviation 3.70
|
-4.10 mg/dL
Standard Deviation 2.20
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Changes in Mean Fasting Lipids (LDL Cholesterol) From Baseline (Time 1) to Time 3
|
2.9 mg/dL
Standard Deviation 9.8
|
5.4 mg/dL
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3
|
5.0 mg/dL
Standard Deviation 2.3
|
9.9 mg/dL
Standard Deviation 37.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Change in Mean Weight (Kg) From Baseline (Time 1) to Time 2
|
-2.9 Kg
Standard Deviation 1.9
|
-1.6 Kg
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Mean Weight (Kg) From Baseline (Time 1) to Time 3
|
-2.7 Kg
Standard Deviation 1.4
|
-2.1 Kg
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 2
|
-1.3 Kg/m^2
Standard Deviation 5.4
|
-0.2 Kg/m^2
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 3
|
-1.3 Kg/m^2
Standard Deviation 0.3
|
-0.9 Kg/m^2
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2
|
-6.0 centimeters (cm)
Standard Deviation 4.6
|
-5.4 centimeters (cm)
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3
|
-2.9 centimeters (cm)
Standard Deviation 0.4
|
-1.6 centimeters (cm)
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 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..
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
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
|
0.044 proportion of participants
|
|
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
|
0.043 proportion of participants
|
|
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
|
-0.044 proportion of participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
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
|
0.043 proportion of participants
|
|
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
|
0.043 proportion of participants
|
|
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
|
-0.174 proportion of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2
|
-7.5 score on a scale
Interval -37.0 to 86.25
|
-35.0 score on a scale
Interval -62.0 to 84.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3
|
-11.0 score on a scale
Interval -37.0 to 49.25
|
31.0 score on a scale
Interval 1.0 to 54.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2
|
-0.5 score on a scale
Standard Deviation 2.1
|
-2.4 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3
|
-10.4 score on a scale
Standard Deviation 3.3
|
-4.9 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2
|
-2.1 score on a scale
Standard Deviation 4.1
|
0.4 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 3
|
-2.5 score on a scale
Standard Deviation 4.1
|
-1.5 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Median High-Sensitivity C-Reactive Protein From Baseline (Time 1) to Time 3
|
86.6 ng/mL
Interval 45.2 to 404.6
|
272.3 ng/mL
Interval 31.6 to 372.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Mean Hair Cortisol Levels From Baseline (Time 1) to Time 3
|
24.29 pg/mg
Standard Deviation 89.05
|
13.39 pg/mg
Standard Deviation 29.01
|
SECONDARY outcome
Timeframe: BaselineThis will be defined as a number of women that agree to participate in the study out of the total women screened for the study.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=143 Participants
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.
|
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.
|
|---|---|---|
|
Number of Eligible Women That Agree to Participate in the Study
|
49 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselineThis will be defined as time (days) from initial contact with research staff to randomization into the study.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Time for Recruitment
|
30 days
Interval 30.0 to 105.0
|
90 days
Interval 45.0 to 121.5
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
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.
|
|---|---|---|
|
Mean Proportion of Group Sessions Participants Attend
|
0.533 proportion of sessions attended
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3)
Post-intervention (Time 2)
|
22 Participants
|
20 Participants
|
|
Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3)
Study Completion (Time 3)
|
21 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Time 2 (Intervention completion, approx. 6 months)Population: This is outcome is only applicable to the intervention group.
A Research Assistant will assess fidelity of the intervention fidelity by keeping an attendance log.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
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.
|
|---|---|---|
|
Proportion of Participants That Attend at Least 80% of the Intervention Session (12-15 Sessions).
|
0.26923077 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: 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?"
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants That Would Recommend the Study to a Friend or Relative.
|
20 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=26 Participants
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.
|
Wait-list Control
n=23 Participants
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.
|
|---|---|---|
|
Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 2
|
-0.193 proportion of participants
|
-0.305 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Education, Physical Activity, and Stress Management Program
n=21 Participants
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.
|
Wait-list Control
n=16 Participants
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.
|
|---|---|---|
|
Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 3
|
-0.154 proportion of participants
|
-0.261 proportion of participants
|
Adverse Events
Education, Physical Activity, and Stress Management Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-list Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Yamnia Cortes, PhD, MPH, RN
University of North Carolina at Chapel Hill
Phone: 319-335-1131
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place