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NCT Number: NCT06376812

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

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

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Key information

Age range

45 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

Location contact

Elizabeth Lorenzo, PhD

PRINCIPAL_INVESTIGATOR

Lisa Thibodeaux

CONTACT

[email protected]

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

physical activity intervention

Behavioral

Physical activity

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Systolic blood pressure

    Time frame: Baseline to 6-months

    Change in systolic blood pressure (mmHg)

  12. Systolic blood pressure

    Time frame: Baseline to 12-months

    Change in systolic blood pressure (mmHg)

  13. Diastolic blood pressure

    Time frame: Baseline to 6-months

    Change in diastolic blood pressure (mmHg)

  14. Diastolic blood pressure

    Time frame: Baseline to 12-months

    Change in diastolic blood pressure (mmHg)

Other outcomes

  1. Abdominal circumference

    Time frame: Baseline to 6-months

    Change in abdominal circumference (cm)

  2. Abdominal circumference

    Time frame: Baseline to 12-months

    Change in abdominal circumference (cm)

  3. Body mass index

    Time frame: Baseline to 6-months

    Change in body mass index (kg/m2)

  4. Body mass index

    Time frame: Baseline to 12-months

    Change in body mass index (kg/m2)

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Thibodeaux, BSN, RNC-OB

CONTACT

[email protected]

409-747-1756

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Apr 19, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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