Recruiting

CARE Intervention

Sponsor:

University of Texas Rio Grande Valley

Code:

NCT07698964

Conditions

Quality of Life

Health Promotion

Blood Pressure Monitoring, Self

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Conversations Advancing Resilience and Empowerment (CARE)

Study Details

Brief summary:

The investigators propose to implement and evaluate the effectiveness of the peer-led CARE Intervention designed to mitigate health differences among rural and low-income communities in Texas. This intervention leverages the expertise of Community Health Workers (CHWs) to empower rural and low-income communities, improving health outcomes through outreach, education, counseling, and social support.

Conditions

Quality of Life

Health Promotion

Blood Pressure Monitoring, Self

Study ID

NCT07698964

Start date

Jun 2, 2026

Status verified date

Jul, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Females between the ages of 18-49
  • Self-report at least one risk factor cardiovascular disease (e.g. high blood pressure, high cholesterol, diabetes, overweight, and family history of heart disease).
  • Reside in one of the priority communities will be eligible to participate in the study.
  • Meet minimum digital literacy criteria, defined as having a working and readily accessible email address and using a smart device daily for texting, calling, and checking email.

Priority communities for the South Texas site include Harris, Hidalgo, Cameron, Willacy, Starr, and Nueces counties plus surrounding coastal communities served by South Coastal AHEC.

Exclusion Criteria:

  • Those not meeting the inclusion criteria will not be eligible to participate

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CARE Intervention Arm

Participants will have up to 60 minute scripted health conversations with a Community Health Worker (CHW) across four visits to leverage opportunities during conversations to address flawed information and provide accurate information about quality of life, wellness, and mental health (Session #1); blood pressure (Session #2); nutrition (Session #3); and physical activity (Session #4).

no intervention: CARE Control Arm

Participants in the control group will receive no intervention, but will be invited to participate in the intervention (health education sessions) after the 6-month follow-up period has been completed.

Interventions

Conversations Advancing Resilience and Empowerment (CARE)

Health promotion intervention to address chronic disease risk

Primary outcome measure

  • Health-related Quality of Life [ Time Frame: From Baseline, end of intervention (following completion of Health Education Session #4; the intervention was designed to last 4 weeks but may be extended due to scheduling considerations), 3 months post-intervention, 6 months post-intervention. ]

Central Contacts and Locations

Central contacts

Candace A Dr. Robledo, PhD, MPH

9562961615Candace.robledo@utrgv.edu

Moises Cisneros, BS, Exercise Science

9562712725Moises.cisneros01@utrgv.edu

Locations

The University of Texas at Rio Grande Valley

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Lindsey Simon, Assistant Director Regulatory Clinical Research

9562968723lindsey.simon@utrgv.edu

Moises Cisneros

9562712725Moises.cisneros01@utrgv.edu

Principal Investigator:

Candace A Robledo, PhD, MPH

CAN DO Houston

Recruiting

Houston, Texas, United States, 77025

Contacts

Jasmine J Opusunju, DrPH, MSEd

832-405-5451jasmine.opusunju@candohouston.org

Principal Investigator:

Jasmine J Opusunju, DrPH, MSEd

More Information

Sponsor

University of Texas Rio Grande Valley

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas Rio Grande Valley on 2026-07-13.