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

Not Applicable

Not yet recruiting

• Conditions: Elevated Blood Pressure; Perimenopause
• Interventions: Behavioral: Physical activity intervention

• Registration Number: NCT06376812
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Study Start: 2026-05
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical activity intervention	Physical activity intervention	Multi-level intervention to increase physical activity

Primary Outcome Measures

Name	Time	Method
Days the activity monitor was worn	Baseline to 6-months	Objectively measured days the wearable activity monitor was worn during the intervention period

Secondary Outcome Measures

Name	Time	Method
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months	Baseline to 12-months	Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period
Systolic blood pressure	Baseline to 12-months	Change in systolic blood pressure (mmHg)
Physical activity as measured by minutes of light intensity physical activity at 6 months	Baseline to 12-months	Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period
Physical activity as measured by minutes of moderate intensity physical activity at 6 months	Baseline to 12-months	Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months	Baseline to 12-months	Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period
Physical activity as measured by minutes of total physical activity at 6 months	Baseline to 12-months	Mean daily minutes of total physical activity taken from accelerometers for a 7 day period
Diastolic blood pressure	Baseline to 12-months	Change in diastolic blood pressure (mmHg)