No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical activity intervention.
- Who it may be relevant to
- Registry conditions: Elevated Blood Pressure, Perimenopause. Basic parameters: 45 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition
Overview
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.
Interventions
- Behavioral Physical activity intervention
Physical activity
Primary outcome measures
- Days the activity monitor was worn [Time frame: Baseline to 6-months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Texas Medical Branch, Galveston — Galveston
Identifiers
NCT: NCT06376812 · 23-0320