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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06376812
Enrollment
40
Registered
2024-04-19
Start date
2027-01-20
Completion date
2029-01-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elevated Blood Pressure, Perimenopause

Keywords

Physical activity, Women's health, Minority health, Behavior change, Hypertension 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.

Interventions

BEHAVIORALPhysical activity intervention

Physical activity

Sponsors

The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Days the activity monitor was wornBaseline to 6-monthsObjectively measured days the wearable activity monitor was worn during the intervention period

Secondary

MeasureTime frameDescription
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 monthsBaseline to 6-monthsMean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period
Physical activity as measured by minutes of moderate intensity physical activity at 6 monthsBaseline to 6-monthsMean 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 monthsBaseline to 6-monthsMean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period
Physical activity as measured by minutes of light intensity physical activity at 6 monthsBaseline to 6-monthsMean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period
Systolic blood pressureBaseline to 6-monthsChange in systolic blood pressure (mmHg)
Diastolic blood pressureBaseline to 6-monthsChange in diastolic blood pressure (mmHg)
Physical activity as measured by minutes of total physical activity at 6 monthsBaseline to 6-monthsMean daily minutes of total physical activity taken from accelerometers for a 7 day period

Other

MeasureTime frameDescription
Abdominal circumferenceBaseline to 6-monthsChange in abdominal circumference (cm)
Body mass indexBaseline to 6-monthsChange in body mass index (kg/m2)

Countries

United States

Contacts

Primary ContactLisa Thibodeaux, BSN, RNC-OB
lbthibod@utmb.edu409-747-1756

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026