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

NCT06376812 — Not applicable, Not yet recruiting, 40 participants, The University of Texas Medical Branch, Galveston

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

RegistryNCT06376812
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, prevention
Enrollment40 (Estimated)
SponsorThe University of Texas Medical Branch, Galveston (Other)
ConditionsElevated Blood Pressure, Perimenopause
InterventionsPhysical activity intervention (Behavioral)
Datesstart 2027-01-20 (estimated), primary completion 2029-01-01 (estimated), completion 2029-01-01 (estimated), first posted 2024-04-19, last updated 2025-12-08
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Elevated Blood Pressure All trials for Perimenopause All trials of Physical activity intervention

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Physical activity interventionExperimentalBehavioral: Physical activity interventionMulti-level intervention to increase physical activity
  • Physical activity intervention (Behavioral): Physical activity

+Outcome measures

Primary outcomes

  • Days the activity monitor was worn [Baseline to 6-months]: Objectively measured days the wearable activity monitor was worn during the intervention period

Secondary outcomes

  • Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline to 12-months]: Mean daily minutes of total physical activity taken from accelerometers for a 7 day period
  • Systolic blood pressure [Baseline to 6-months]: Change in systolic blood pressure (mmHg)
  • Systolic blood pressure [Baseline to 12-months]: Change in systolic blood pressure (mmHg)
  • Diastolic blood pressure [Baseline to 6-months]: Change in diastolic blood pressure (mmHg)
  • Diastolic blood pressure [Baseline to 12-months]: Change in diastolic blood pressure (mmHg)

Other outcomes

  • Abdominal circumference [Baseline to 6-months]: Change in abdominal circumference (cm)
  • Abdominal circumference [Baseline to 12-months]: Change in abdominal circumference (cm)
  • Body mass index [Baseline to 6-months]: Change in body mass index (kg/m2)
  • Body mass index [Baseline to 12-months]: Change in body mass index (kg/m2)

+Eligibility

Sex: Female, ages: 45 Years to 50 Years

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

+Locations (1)

FacilityCityCountryStatus
University of Texas Medical Branch, GalvestonGalveston, TexasUnited States

+Investigators