A Randomized Control Trial of Conversations Advancing Resilience and Empowerment (CARE) Intervention
CARE
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Jun 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2026
CompletedFirst Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
July 13, 2026
July 1, 2026
8 months
June 16, 2026
July 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Health-related Quality of Life
The health-related quality of life (HRQOL) is measured by a decrease in the number of total unhealthy days compared to the control group at baseline, end of intervention at 4-weeks, and the 3- and 6-month follow-ups. The assessment used to measure this outcome is the World Health Organization Quality-of-Life-Scale Brief version (WHOQOL-BREF). The items from this assessment are scored using a likert scale of 1-5, 1 being the worst and 5 being the best. The raw score is calculated for each facet and each domain. Both facets and domains are scored through a simple summation of each item in that scale. Each question contributes equally to the facet score and each facet contributes equally to the domain score. Since each facet has four items with response values of 1 through 5, the raw score for any facet must have a minimum value of 4 and a maximum value of 20. Community narratives can be powerful tools that increase health narratives and promote behavior change.
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.
Secondary Outcomes (9)
Flawed information on nutrition, physical activity, blood pressure, and mental health
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.
Health knowledge on nutrition, physical activity, blood pressure, and mental health
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
Attitudes and beliefs on nutrition, physical activity, blood pressure, and sleep
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.
Health Behavior
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
Physical and Mental Wellbeing
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
- +4 more secondary outcomes
Study Arms (2)
CARE Intervention Arm
EXPERIMENTALParticipants 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).
CARE Control Arm
NO INTERVENTIONParticipants 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
Health promotion intervention to address chronic disease risk
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CAN DO Houstoncollaborator
- University of Texas Rio Grande Valleylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (2)
The University of Texas at Rio Grande Valley
Edinburg, Texas, 78539, United States
CAN DO Houston
Houston, Texas, 77025, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Candace A Robledo, PhD, MPH
The University of Texas at Rio Grande Valley
- PRINCIPAL INVESTIGATOR
Jasmine J Opusunju, DrPH, MSEd
CAN DO Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor/Division Chief of Population Health & Biostatistics
Study Record Dates
First Submitted
June 16, 2026
First Posted
July 13, 2026
Study Start
June 2, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
July 13, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- De-identified individual participant data (IPD) and accompanying supporting documentation will be made available beginning 3 months after publication of the primary study results. The data will remain available for a period of up to 3 years following publication. Access during this time frame will be provided to qualified researchers upon reasonable request and completion of applicable review procedures, in accordance with institutional policies, data use agreements, and relevant regulatory requirements.
- Access Criteria
- Access to de-identified individual participant data (IPD) and supporting documentation will be granted to qualified researchers who submit a methodologically sound research proposal with analyses that are scientifically and ethically appropriate, and consistent with or complementary to the objectives of the original study. Proposed statistical methods must be clearly described and may be subject to review for rigor and feasibility. All requests must include a formal application outlining the research objectives, analysis plan, and data requirements. Requests will be reviewed by the study's principal investigator and/or a designated data governance committee to ensure compliance with institutional policies, ethical standards, and applicable regulations. Upon approval, data will be shared through a secure platform following execution of a data use agreement (DUA) that defines conditions for access, use, data protection, and publication.
Individual participant data (IPD) collected throughout the study and used in the primary and secondary analyses will be shared in de-identified form to protect participant confidentiality. The shared dataset will include variables necessary to reproduce the analyses and validate the study findings. The supporting documentation that will be provided includes, our Study Protocol, the Statistical Analysis Plan (SAP), Clinical Study Report (CSR), and analytic code used to generate the results. Data will be made available to qualified researchers upon reasonable request and review, in accordance with institutional policies, data use agreements, and applicable privacy and regulatory requirements.