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

December 1, 2025 updated by: The University of Texas Medical Branch, Galveston

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lisa Thibodeaux, BSN, RNC-OB
  • Phone Number: 409-747-1756
  • Email: lbthibod@utmb.edu

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch, Galveston
        • Contact:
        • Principal Investigator:
          • Elizabeth Lorenzo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical activity intervention
Multi-level intervention to increase physical activity
Behavioral: Physical activity intervention
Physical activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to 6-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period
Baseline to 12-months
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
Baseline to 6-months
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
Baseline to 12-months
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
Baseline to 6-months
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
Baseline to 12-months
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
Baseline to 6-months
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
Baseline to 12-months
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
Baseline to 6-months
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
Baseline to 12-months
Systolic blood pressure
Time Frame: Baseline to 6-months
Change in systolic blood pressure (mmHg)
Baseline to 6-months
Systolic blood pressure
Time Frame: Baseline to 12-months
Change in systolic blood pressure (mmHg)
Baseline to 12-months
Diastolic blood pressure
Time Frame: Baseline to 6-months
Change in diastolic blood pressure (mmHg)
Baseline to 6-months
Diastolic blood pressure
Time Frame: Baseline to 12-months
Change in diastolic blood pressure (mmHg)
Baseline to 12-months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Abdominal circumference
Time Frame: Baseline to 6-months
Change in abdominal circumference (cm)
Baseline to 6-months
Abdominal circumference
Time Frame: Baseline to 12-months
Change in abdominal circumference (cm)
Baseline to 12-months
Body mass index
Time Frame: Baseline to 6-months
Change in body mass index (kg/m2)
Baseline to 6-months
Body mass index
Time Frame: Baseline to 12-months
Change in body mass index (kg/m2)
Baseline to 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Lorenzo, PhD, RN, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-0320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

We agree to deposit and/or make available our data upon completion of the clinical trial and acceptance of the data for publication. Data will be stored in the repository for at least 3 years, as required by federal retention guidelines.

IPD Sharing Access Criteria

Data will be shared via openICPSR as open access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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