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

The University of Texas System (UT)

Status: Begins enrollment in 11 months

Conditions: Elevated Blood Pressure; Perimenopause

Treatments: Behavioral: Physical activity intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06376812

23-0320

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 45 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Physical activity intervention

Experimental group

Description:

Multi-level intervention to increase physical activity

Treatment:

Behavioral: Physical activity intervention