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

NCT06376812 | Not Yet Recruiting DMC

• 1 other identifier: 23-0320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elevated Blood Pressure; Perimenopause

Keywords

Physical activity; Women's health; Minority health; Behavior change; Hypertension prevention

Outcome Measures

Primary Outcomes (1)

• Days the activity monitor was worn

  Objectively measured days the wearable activity monitor was worn during the intervention period

  Baseline to 6-months

Secondary Outcomes (14)

• Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months

  Baseline to 6-months

• Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months

  Baseline to 12-months

• Physical activity as measured by minutes of moderate intensity physical activity at 6 months

  Baseline to 6-months

• Physical activity as measured by minutes of moderate intensity physical activity at 6 months

  Baseline to 12-months

• Physical activity as measured by minutes of vigorous intensity physical activity at 6 months

  Baseline to 6-months

Other Outcomes (4)

• Abdominal circumference

  Baseline to 6-months

• Abdominal circumference

  Baseline to 12-months

• Body mass index

  Baseline to 6-months

Study Arms (1)

Physical activity intervention

EXPERIMENTAL

Multi-level intervention to increase physical activity

Behavioral: Physical activity intervention

Interventions

Physical activity intervention BEHAVIORAL

Physical activity

Physical activity intervention

Eligibility Criteria

• Age: 45 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Elizabeth Lorenzo, PhD, RN

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Thibodeaux, BSN, RNC-OB

CONTACT

409-747-1756; lbthibod@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start (Estimated): January 20, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Data will be shared via openICPSR as open access.

Locations

US (1)