No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women

Elevated Blood Pressure Clinical Trial

Official title:

No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376812
• Other study ID #: 23-0320
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2026
• Est. completion date: January 2029

Study information

• Verified date: April 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: Lisa Thibodeaux, BSN, RNC-OB
• Phone: 409-747-1756
• Email: lbthibod[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test the effects of a physical activity intervention among midlife Hispanic women.

Description:

The menopausal transition in midlife is a critical juncture where women experience life transitions and adverse physiological and psychological changes that increase the risk for hypertension and cardiovascular diseases in later life. Physical activity improves blood pressure, biomarkers of hypertension, sleep, mood, and well-being; however, Hispanic women meet physical activity recommendations at lower levels than non-Hispanic White women. The investigator will examine the feasibility of the physical activity intervention among sedentary midlife Hispanic women in the menopausal transition with elevated blood pressure, exploring changes in physical activity and health.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Female

2. Hispanic by self-report

3. Able to speak and read English

4. Sedentary

5. Age 45-50

6. Diagnosed with elevated blood pressure or objectively measured systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg averaged from = 2 measures on = 2 outpatient visits

7. Symptoms consistent with the menopause transition (persistent difference of =7 days in the length of consecutive cycles; persistence is defined as recurrence within 10 cycles of the first variable length cycle)

8. Apparently healthy

9. Self-reported ability to engage in moderate intensity physical activity

10. Access to a smart device that is compatible with a Fitbit application

Exclusion Criteria:

1. Self-reported physical activity of =150 minutes per week

2. Answered yes to any question on the Physical Activity Readiness (PAR-Q+) questionnaire

3. Post-menopausal (12-months without a menstrual cycle)

4. Diagnosed hypertension

5. Cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers

6. Previous hysterectomy, oophorectomy, and/or uterine ablation

7. Medication to treat hypertension, elevated glucose, cholesterol, depression, anxiety, and insomnia

8. Hormonal medication via any route or implants

9. Tamoxifen

10. Pregnant, planning to become pregnant, or breastfeeding

11. Planning to move out of the Galveston/Houston area in the next 18 months

12. Current participation in another physical activity study or program

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension
• Perimenopause

Intervention

Behavioral:
• Physical activity intervention
Physical activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abdominal circumference	Change in abdominal circumference (cm)	Baseline to 6-months
Other	Abdominal circumference	Change in abdominal circumference (cm)	Baseline to 12-months
Other	Body mass index	Change in body mass index (kg/m2)	Baseline to 6-months
Other	Body mass index	Change in body mass index (kg/m2)	Baseline to 12-months
Primary	Days the activity monitor was worn	Objectively measured days the wearable activity monitor was worn during the intervention period	Baseline to 6-months
Secondary	Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months	Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Secondary	Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months	Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Secondary	Physical activity as measured by minutes of moderate intensity physical activity at 6 months	Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Secondary	Physical activity as measured by minutes of moderate intensity physical activity at 6 months	Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Secondary	Physical activity as measured by minutes of vigorous intensity physical activity at 6 months	Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Secondary	Physical activity as measured by minutes of vigorous intensity physical activity at 6 months	Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Secondary	Physical activity as measured by minutes of light intensity physical activity at 6 months	Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Secondary	Physical activity as measured by minutes of light intensity physical activity at 6 months	Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Secondary	Physical activity as measured by minutes of total physical activity at 6 months	Mean daily minutes of total physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Secondary	Physical activity as measured by minutes of total physical activity at 6 months	Mean daily minutes of total physical activity taken from accelerometers for a 7 day period	Baseline to 12-months
Secondary	Systolic blood pressure	Change in systolic blood pressure (mmHg)	Baseline to 6-months
Secondary	Systolic blood pressure	Change in systolic blood pressure (mmHg)	Baseline to 12-months
Secondary	Diastolic blood pressure	Change in diastolic blood pressure (mmHg)	Baseline to 6-months
Secondary	Diastolic blood pressure	Change in diastolic blood pressure (mmHg)	Baseline to 12-months