No Time to Pause: Physical Activity to Improve Health of... | NCT06376812

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

NCT06376812

Sponsor

The University of Texas Medical Branch, Galveston

Status

Not yet recruiting

Last Update Posted

Dec 8, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Elevated Blood Pressure
Perimenopause

Interventions

Physical activity intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2027Estimated

Primary Completion Date

Jan 2029Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Apr 16, 2024

First Submission Date that Met QC Criteria

Apr 16, 2024

First Posted Date

Apr 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2025

Last Update Posted Date

Dec 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physical activity intervention	Experimental	Multi-level intervention to increase physical activity	Behavioral: Physical activity intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical activity intervention	Behavioral	Physical activity	Physical activity intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months	Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period	Baseline to 6-months
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months

Other Outcomes

Measure	Description	Time Frame
Abdominal circumference	Change in abdominal circumference (cm)	Baseline to 6-months
Abdominal circumference	Change in abdominal circumference (cm)

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Lisa Thibodeaux, BSN, RNC-OB	Contact	409-747-1756		lbthibod@utmb.edu

Name	Affiliation	Role
Elizabeth Lorenzo, PhD, RN	University of Texas	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Medical Branch, Galveston		Galveston	Texas	77555	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The research data from this project will be deposited with a service of the Inter-university Consortium for Political and Social Research (ICPSR), openICPSR, to ensure that the research community has long-term access to the data.

Types

Study Protocol
Statistical Analysis Plan (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.

URL

Not provided

ID	Term
D006973	Hypertension
D009043	Motor Activity

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001519	Behavior