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Healthy Communities Through CHW Initiatives

Creating Healthy Communities Through a Church-based, Community Health Worker-led Initiative

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05965869
Enrollment
400
Registered
2023-07-28
Start date
2023-08-01
Completion date
2028-07-31
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Risk, Diabetes Mellitus, Type 2

Brief summary

Latino(a)s suffer from poor social determinants of health (SODH) conditions more than non-minority populations, and being a minority is risk factor alone for diabetes. In the proposed study, investigators will assist church members in becoming Community Health Workers (CHWs), train them in diabetes, and to track the ability to address healthcare access and quality barriers using an online platform.

Detailed description

Social determinants of health (SODH) are environmental variables that determine quality-of-life outcomes and risks that are delineated into five domains. Inequities in SODH are directly associated with diabetes. Latino(a)s suffer from poor SODH conditions more than non-minority populations, and being a minority is risk factor alone for diabetes. To quantify progress in SODH, Healthy People 2030 has provided specific objectives to measure each domain (economic stability, education access and quality, healthcare access and quality, neighborhood and build environment, and social and community context); this application focuses on the healthcare access and quality domain. While there are numerous screening mechanisms to identify SODH conditions, there is a critical need to implement interventions that are translatable into real-world practices. A successful intervention requires several components. For the community, sites are needed that can bring individuals together, making collaboration with faith-based establishments of particular interest. Religious institutions provide an infrastructure that will persist beyond funding periods and a framework for the community to share a responsibility of health promotion. Churches also provide an accessible and familiar setting to provide health outreach programs but often lack trained personnel to conduct initiatives. In addition, training leaders within these settings who can reach the community is essential. Community Health Workers (CHWs) are trusted leaders within their community. Training church members to become CHWs potentially establishes a site familiar to the surrounding communities led by trusted individuals who understand the population at hand. Finally, secure avenues to collect and transmit data are needed. Utilizing secure HIPAA-approved technology reduces risks of loss of confidentiality while allowing collection of valuable information that may not have been collected otherwise. Since COVID-19, investigators have increased the use of online platforms, but these modalities must be translatable to personnel with potentially little to no technological experience. To address gaps in SDOH, the investigators propose a 6-month church-based intervention for Latino(a)s with and at risk for diabetes (n=460) in a two phase study, pilot followed by main study. We will assist church members in becoming CHWs, train them in diabetes, and use an online platform to track the ability to address healthcare access and quality barriers. The research team will provide telementoring to local community teams (church leadership and CHWs) to initiate the intervention. We will test the feasibility of the program using three pre-established areas of focus: acceptability, integration, limited efficacy testing.

Interventions

CHWs will contact participants weekly via phone or text, send bimonthly diabetes education videos, and provide optional monthly seminars.

Sponsors

The University of Texas Medical Branch, Galveston
Lead SponsorOTHER
Baylor College of Medicine
CollaboratorOTHER
University of Houston
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Spanish-speaking Latino(a)s adults

Exclusion criteria

* pregnant state or anticipated state in the next 6 months * Type 1 diabetes diagnosis * Not geographically located to reach church site/attend classes * Not Spanish-speaking, and * Self-disclosed diagnosis of schizophrenia, psychotic/delusional disorder, or severe Alzheimer's disease.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the integration of the intervention6-monthsCHW ability to use software as measured by the number of anticipated vs. actual documents uploaded at 6-months

Secondary

MeasureTime frameDescription
Provide acceptability data of the intervention6-monthsSite, CHW, and participant survey data at 6-months as measured on a Likert scale, e.g., Likert scale from 1 to 5 where 1 is unsatisfied and 5 is very satisfied. Participant participation trends in the intervention

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORElizabeth Vaughan, DO

University of Texas Medical Branch, Galveston

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026