No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition
| Registry | NCT06376812 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, prevention |
| Enrollment | 40 (Estimated) |
| Sponsor | The University of Texas Medical Branch, Galveston (Other) |
| Conditions | Elevated Blood Pressure, Perimenopause |
| Interventions | Physical activity intervention (Behavioral) |
| Dates | start 2027-01-20 (estimated), primary completion 2029-01-01 (estimated), completion 2029-01-01 (estimated), first posted 2024-04-19, last updated 2025-12-08 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Elevated Blood Pressure All trials for Perimenopause All trials of Physical activity intervention
This study will test the effects of a physical activity intervention among midlife Hispanic women.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity intervention | Multi-level intervention to increase physical activity |
Sex: Female, ages: 45 Years to 50 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Texas Medical Branch, Galveston | Galveston, Texas | United States |