Elevated Blood PressureNCT06376812
No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women
A study testing Physical activity intervention in people with Elevated Blood Pressure and Perimenopause, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This study will test the effects of a physical activity intervention among midlife Hispanic women. Read more about this study
- Who is it for?
- Ages 45 to 50 years, women only
- Conditions the study is for
- Elevated Blood Pressure, Perimenopause
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2027to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Hispanic by self-report
- Able to speak and read English
- Sedentary
- Age 45-50
- 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
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- 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)
- Apparently healthy
- Self-reported ability to engage in moderate intensity physical activity
- Access to a smart device that is compatible with a Fitbit application
Who cannot join
- Self-reported physical activity of ≥150 minutes per week
- Answered yes to any question on the Physical Activity Readiness (PAR-Q+) questionnaire
- Post-menopausal (12-months without a menstrual cycle)
- Diagnosed hypertension
- Cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers
- Previous hysterectomy, oophorectomy, and/or uterine ablation
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- Medication to treat hypertension, elevated glucose, cholesterol, depression, anxiety, and insomnia
- Hormonal medication via any route or implants
- Tamoxifen
- Pregnant, planning to become pregnant, or breastfeeding
- Planning to move out of the Galveston/Houston area in the next 18 months
- Current participation in another physical activity study or program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
Lisa Thibodeaux, lbthibod@utmb.edu
Elizabeth Lorenzo, PhD
About this study
Official title: No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition
This study will test the effects of a physical activity intervention among midlife Hispanic women.
Read the 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.
- Conditions
- Elevated Blood Pressure, Perimenopause
- Being tested
- Physical activity intervention
- Keywords
- Physical activity, Women's health, Minority health, Behavior change, Hypertension prevention
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
Physical activity
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | Multi-level intervention to increase physical activity Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days the activity monitor was worn
Objectively measured days the wearable activity monitor was worn during the intervention period
Measured: Baseline to 6-months
Secondary outcomes (14)
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 6-months
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 12-months
Physical activity as measured by minutes of moderate intensity physical activity at 6 months
Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 6-months
Physical activity as measured by minutes of moderate intensity physical activity at 6 months
Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 12-months
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months
Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 6-months
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months
Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 12-months
Physical activity as measured by minutes of light intensity physical activity at 6 months
Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 6-months
Physical activity as measured by minutes of light intensity physical activity at 6 months
Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 12-months
Physical activity as measured by minutes of total physical activity at 6 months
Mean daily minutes of total physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 6-months
Physical activity as measured by minutes of total physical activity at 6 months
Mean daily minutes of total physical activity taken from accelerometers for a 7 day period
Measured: Baseline to 12-months
Systolic blood pressure
Change in systolic blood pressure (mmHg)
Measured: Baseline to 6-months
Systolic blood pressure
Change in systolic blood pressure (mmHg)
Measured: Baseline to 12-months
Diastolic blood pressure
Change in diastolic blood pressure (mmHg)
Measured: Baseline to 6-months
Diastolic blood pressure
Change in diastolic blood pressure (mmHg)
Measured: Baseline to 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start20 Jan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Lorenzo, PhD, RN, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376812
- Sponsor's protocol ID
- 23-0320
- Status last verified
- Dec 2025
- First submitted
- 16 Apr 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research data from this project will be deposited with a service of the Inter-university Consortium for Political and Social Research (ICPSR), openICPSR, to ensure that the research community has long-term access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition
- ClinicalTrials.gov ID
- NCT06376812
- Acronym / sponsor ID
- 23-0320
- Conditions
- Elevated Blood Pressure, Perimenopause
- Keywords
- Physical activity, Women's health, Minority health, Behavior change, Hypertension prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 20 Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionMulti-level intervention to increase physical activity |
Who may qualify
- Ages
- 45 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female
- Hispanic by self-report
- Able to speak and read English
- Sedentary
- Age 45-50
Key exclusion criteria (12 listed)
- Self-reported physical activity of ≥150 minutes per week
- Answered yes to any question on the Physical Activity Readiness (PAR-Q+) questionnaire
- Post-menopausal (12-months without a menstrual cycle)
- Diagnosed hypertension
- Cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionPhysical activity | Behavioural | Physical activity intervention |
Primary outcome
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
14 secondary outcomes
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
Time frame: Baseline to 6-months
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
Time frame: Baseline to 12-months
Physical activity as measured by minutes of moderate intensity physical activity at 6 months
Time frame: Baseline to 6-months
Physical activity as measured by minutes of moderate intensity physical activity at 6 months
Time frame: Baseline to 12-months
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months
Time frame: Baseline to 6-months
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months
Time frame: Baseline to 12-months
Physical activity as measured by minutes of light intensity physical activity at 6 months
Time frame: Baseline to 6-months
Physical activity as measured by minutes of light intensity physical activity at 6 months
Time frame: Baseline to 12-months
Physical activity as measured by minutes of total physical activity at 6 months
Time frame: Baseline to 6-months
Physical activity as measured by minutes of total physical activity at 6 months
Time frame: Baseline to 12-months
Systolic blood pressure
Time frame: Baseline to 6-months
Systolic blood pressure
Time frame: Baseline to 12-months
Diastolic blood pressure
Time frame: Baseline to 6-months
Diastolic blood pressure
Time frame: Baseline to 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. The research data from this project will be deposited with a service of the Inter-university Consortium for Political and Social Research (ICPSR), openICPSR, to ensure that the research community has long-term access to the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Lorenzo, PhD, RN principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Elevated Blood Pressure and Perimenopause, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Thibodeaux, BSN, RNC-OB (409-747-1756, lbthibod@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days the activity monitor was worn (time frame: Baseline to 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.