Clinical trial NCT06376812: No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women
Official title: No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elevated Blood Pressure
Perimenopause
Keywords: Physical activity
Women's health
Minority health
Behavior change
Hypertension prevention
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Days the activity monitor was worn
timeFrame: Baseline to 6-months
Secondary outcomes:
measure: Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
timeFrame: Baseline to 6-months
measure: Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
timeFrame: Baseline to 12-months
measure: Physical activity as measured by minutes of moderate intensity physical activity at 6 months
timeFrame: Baseline to 6-months
measure: Physical activity as measured by minutes of moderate intensity physical activity at 6 months
timeFrame: Baseline to 12-months
measure: Physical activity as measured by minutes of vigorous intensity physical activity at 6 months
timeFrame: Baseline to 6-months
measure: Physical activity as measured by minutes of vigorous intensity physical activity at 6 months
timeFrame: Baseline to 12-months
measure: Physical activity as measured by minutes of light intensity physical activity at 6 months
timeFrame: Baseline to 6-months
measure: Physical activity as measured by minutes of light intensity physical activity at 6 months
timeFrame: Baseline to 12-months
measure: Physical activity as measured by minutes of total physical activity at 6 months
timeFrame: Baseline to 6-months
measure: Physical activity as measured by minutes of total physical activity at 6 months
timeFrame: Baseline to 12-months
measure: Systolic blood pressure
timeFrame: Baseline to 6-months
measure: Systolic blood pressure
timeFrame: Baseline to 12-months
measure: Diastolic blood pressure
timeFrame: Baseline to 6-months
measure: Diastolic blood pressure
timeFrame: Baseline to 12-months
Other outcomes:
measure: Abdominal circumference
timeFrame: Baseline to 6-months
measure: Abdominal circumference
timeFrame: Baseline to 12-months
measure: Body mass index
timeFrame: Baseline to 6-months
measure: Body mass index
timeFrame: Baseline to 12-months
Locations:
Study officials:
affiliation: University of Texas
name: Elizabeth Lorenzo, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: