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Not yet recruitingNCT06376812ClinicalTrials.gov record

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

Elevated Blood Pressure · Perimenopause

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
45 years - 50 years
Sex eligible
Female
Healthy volunteers
Not accepted
Participants
40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Read the 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
Physical activity intervention

Multi-level intervention to increase physical activity

Behavioral: Physical activity intervention

Physical activity intervention BEHAVIORAL

Physical activity

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Days the activity monitor was worn

Time frame: Baseline to 6-months

Objectively measured days the wearable activity monitor was worn during the intervention period

Secondary measures

Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months

Time frame: Baseline to 6-months

Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period

Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months

Time frame: Baseline to 12-months

Mean 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 months

Time frame: Baseline to 6-months

Mean daily minutes of moderate 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

Time frame: 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

Time frame: Baseline to 6-months

Mean daily minutes of vigorous 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

Time frame: 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 light intensity physical activity at 6 months

Time frame: Baseline to 6-months

Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period

Physical activity as measured by minutes of light intensity physical activity at 6 months

Time frame: 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 total physical activity at 6 months

Time frame: Baseline to 6-months

Mean daily minutes of total physical activity taken from accelerometers for a 7 day period

Physical activity as measured by minutes of total physical activity at 6 months

Time frame: Baseline to 12-months

Mean daily minutes of total physical activity taken from accelerometers for a 7 day period

Systolic blood pressure

Time frame: Baseline to 6-months

Change in systolic blood pressure (mmHg)

Systolic blood pressure

Time frame: Baseline to 12-months

Change in systolic blood pressure (mmHg)

Diastolic blood pressure

Time frame: Baseline to 6-months

Change in diastolic blood pressure (mmHg)

Diastolic blood pressure

Time frame: Baseline to 12-months

Change in diastolic blood pressure (mmHg)

Other measures

Abdominal circumference

Time frame: Baseline to 6-months

Change in abdominal circumference (cm)

Abdominal circumference

Time frame: Baseline to 12-months

Change in abdominal circumference (cm)

Body mass index

Time frame: Baseline to 6-months

Change in body mass index (kg/m2)

Body mass index

Time frame: Baseline to 12-months

Change in body mass index (kg/m2)

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

University of Texas Medical Branch, GalvestonGalveston, Texas, United StatesStatus unknown
Lisa ThibodeauxCONTACTlbthibod@utmb.edu
Elizabeth Lorenzo, PhDPRINCIPAL_INVESTIGATOR
View location on map ↗

Study team and timeline

Lead sponsor
The University of Texas Medical Branch, Galveston
Study start
Apr 20, 2027 Estimated
Primary completion
2029-01 Estimated
Study completion
2029-01 Estimated
First posted
Apr 19, 2024 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Lisa Thibodeaux, BSN, RNC-OBCONTACTlbthibod@utmb.edu409-747-1756
Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026