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

NCT ID: NCT06376812

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-01-20
• Study Completion Date: 2029-01-31

Brief Summary

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.

Conditions

Elevated Blood Pressure; Perimenopause

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Physical activity intervention

Multi-level intervention to increase physical activity

Group Type: EXPERIMENTAL

Physical activity intervention

Intervention Type: BEHAVIORAL

Physical activity

Interventions

Physical activity intervention

Physical activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Lorenzo, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Medical Branch, Galveston

Galveston, Texas, United States

Countries

United States

Central Contacts

Lisa Thibodeaux, BSN, RNC-OB

Role: CONTACT

lbthibod@utmb.edu

409-747-1756

Facility Contacts

Lisa Thibodeaux

Role: primary

lbthibod@utmb.edu

Other Identifiers

23-0320

Identifier Type: -

Identifier Source: org_study_id