Diabetes Mellitus, Type 2NCT05965869
Healthy Communities Through CHW Initiatives
A study testing diabetes program in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus Risk, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus Risk
- What is being tested?
- diabetes program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Spanish-speaking Latino(a)s adults
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0158
About this study
Official title: Creating Healthy Communities Through a Church-based, Community Health Worker-led Initiative
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus Risk
- Being tested
- diabetes program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetes programOther
CHWs will contact participants weekly via phone or text, send bimonthly diabetes education videos, and provide optional monthly seminars.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes program and education | Experimental | Receive diabetes program and education Receives: Other: diabetes program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the integration of the intervention
CHW ability to use software as measured by the number of anticipated vs. actual documents uploaded at 6-months
Measured: 6-months
Secondary outcomes (1)
Provide acceptability data of the intervention
Site, 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
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, University of Houston
- Responsible party
- Sponsor
- Investigators
- Elizabeth Vaughan, DO, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965869
- Sponsor's protocol ID
- 23-0169
- Other IDs
- 23-0169
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
PubMed 36273386Hessler D, Fisher L, Dickinson M, Dickinson P, Parra J, Potter MB. The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Transl Behav Med. 2022 Oct 7;12(9):909-918. doi: 10.1093/tbm/ibac046.
PubMed 36205473Levy NK, Park A, Solis D, Hu L, Langford AT, Wang B, Rogers ES. Social Determinants of Health and Diabetes-Related Distress in Patients With Insulin-Dependent Type 2 Diabetes: Cross-sectional, Mixed Methods Approach. JMIR Form Res. 2022 Oct 12;6(10):e40164. doi: 10.2196/40164.
PubMed 36222807Wagner J, Bermudez-Millan A, Buckley T, Buxton OM, Feinn R, Kong S, Kuoch T, Nye LM, Scully M. Self-reported outcomes of a randomized trial comparing three community health worker interventions for diabetes prevention among Cambodian Americans with depression. Patient Educ Couns. 2022 Dec;105(12):3501-3508. doi: 10.1016/j.pec.2022.09.011. Epub 2022 Oct 6.
PubMed 36307274Deverts DJ, Heisler M, Kieffer EC, Piatt GA, Valbuena F, Yabes JG, Guajardo C, Ilarraza-Montalvo D, Palmisano G, Koerbel G, Rosland AM. Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial. Trials. 2022 Oct 3;23(1):841. doi: 10.1186/s13063-022-06764-1.
PubMed 36192769Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
PubMed 10259963Keegan CN, Johnston CA, Cardenas VJ Jr, Vaughan EM. Evaluating the Impact of Telehealth-Based, Diabetes Medication Training for Community Health Workers on Glycemic Control. J Pers Med. 2020 Sep 11;10(3):121. doi: 10.3390/jpm10030121.
PubMed 32932865Garcia AA, Villagomez ET, Brown SA, Kouzekanani K, Hanis CL. The Starr County Diabetes Education Study: development of the Spanish-language diabetes knowledge questionnaire. Diabetes Care. 2001 Jan;24(1):16-21. doi: 10.2337/diacare.24.1.16.
PubMed 11194219Dumville JC, Torgerson DJ, Hewitt CE. Reporting attrition in randomised controlled trials. BMJ. 2006 Apr 22;332(7547):969-71. doi: 10.1136/bmj.332.7547.969.
PubMed 16627519Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
PubMed 27563386Belone L, Lucero JE, Duran B, Tafoya G, Baker EA, Chan D, Chang C, Greene-Moton E, Kelley MA, Wallerstein N. Community-Based Participatory Research Conceptual Model: Community Partner Consultation and Face Validity. Qual Health Res. 2016 Jan;26(1):117-35. doi: 10.1177/1049732314557084. Epub 2014 Oct 31.
PubMed 25361792Rimawi A, Shah A, Louis H, Scales D, Kheiran JA, Jawabreh N, Yunez S, Horino M, Seita A, Wispelwey B. Community Health Worker Program Outcomes for Diabetes and Hypertension Control in West Bank Refugee Camps: A Retrospective Matched Cohort Study. Glob Health Sci Pract. 2022 Oct 31;10(5):e2200168. doi: 10.9745/GHSP-D-22-00168. Print 2022 Oct 31.
PubMed 36316145Vaughan EM, Johnson E, Naik AD, Amspoker AB, Balasubramanyam A, Virani SS, Ballantyne CM, Johnston CA, Foreyt JP. Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up. J Gen Intern Med. 2022 Sep;37(12):3062-3069. doi: 10.1007/s11606-021-07363-7. Epub 2022 Feb 7.
PubMed 35132555Vaughan EM, Naik AD, Amspoker AB, Johnston CA, Landrum JD, Balasubramanyam A, Virani SS, Ballantyne CM, Foreyt JP. Mentored implementation to initiate a diabetes program in an underserved community: a pilot study. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002320. doi: 10.1136/bmjdrc-2021-002320.
PubMed 34385148
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Healthy Communities Through a Church-based, Community Health Worker-led Initiative
- ClinicalTrials.gov ID
- NCT05965869
- Acronym / sponsor ID
- 23-0169
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus Risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, University of Houston
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes program and education | Experimental | Other: diabetes programReceive diabetes program and education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Spanish-speaking Latino(a)s adults
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diabetes programCHWs will contact participants weekly via phone or text, send bimonthly diabetes education videos, and provide optional monthly seminars. | Other | Diabetes program and education |
Primary outcome
Evaluate the integration of the intervention
Time frame: 6-months
CHW ability to use software as measured by the number of anticipated vs. actual documents uploaded at 6-months
1 secondary outcome
Provide acceptability data of the intervention
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 36273386Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
- Background: PubMed 36205473Hessler D, Fisher L, Dickinson M, Dickinson P, Parra J, Potter MB. The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Transl Behav Med. 2022 Oct 7;12(9):909-918. doi: 10.1093/tbm/ibac046.
- Background: PubMed 36222807Levy NK, Park A, Solis D, Hu L, Langford AT, Wang B, Rogers ES. Social Determinants of Health and Diabetes-Related Distress in Patients With Insulin-Dependent Type 2 Diabetes: Cross-sectional, Mixed Methods Approach. JMIR Form Res. 2022 Oct 12;6(10):e40164. doi: 10.2196/40164.
- Background: PubMed 36307274Wagner J, Bermudez-Millan A, Buckley T, Buxton OM, Feinn R, Kong S, Kuoch T, Nye LM, Scully M. Self-reported outcomes of a randomized trial comparing three community health worker interventions for diabetes prevention among Cambodian Americans with depression. Patient Educ Couns. 2022 Dec;105(12):3501-3508. doi: 10.1016/j.pec.2022.09.011. Epub 2022 Oct 6.
- Background: PubMed 36192769Deverts DJ, Heisler M, Kieffer EC, Piatt GA, Valbuena F, Yabes JG, Guajardo C, Ilarraza-Montalvo D, Palmisano G, Koerbel G, Rosland AM. Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial. Trials. 2022 Oct 3;23(1):841. doi: 10.1186/s13063-022-06764-1.
- Background: PubMed 10259963Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- Background: PubMed 32932865Keegan CN, Johnston CA, Cardenas VJ Jr, Vaughan EM. Evaluating the Impact of Telehealth-Based, Diabetes Medication Training for Community Health Workers on Glycemic Control. J Pers Med. 2020 Sep 11;10(3):121. doi: 10.3390/jpm10030121.
- Background: PubMed 11194219Garcia AA, Villagomez ET, Brown SA, Kouzekanani K, Hanis CL. The Starr County Diabetes Education Study: development of the Spanish-language diabetes knowledge questionnaire. Diabetes Care. 2001 Jan;24(1):16-21. doi: 10.2337/diacare.24.1.16.
- Background: PubMed 16627519Dumville JC, Torgerson DJ, Hewitt CE. Reporting attrition in randomised controlled trials. BMJ. 2006 Apr 22;332(7547):969-71. doi: 10.1136/bmj.332.7547.969.
- Background: PubMed 27563386Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
- Background: PubMed 25361792Belone L, Lucero JE, Duran B, Tafoya G, Baker EA, Chan D, Chang C, Greene-Moton E, Kelley MA, Wallerstein N. Community-Based Participatory Research Conceptual Model: Community Partner Consultation and Face Validity. Qual Health Res. 2016 Jan;26(1):117-35. doi: 10.1177/1049732314557084. Epub 2014 Oct 31.
- Background: PubMed 36316145Rimawi A, Shah A, Louis H, Scales D, Kheiran JA, Jawabreh N, Yunez S, Horino M, Seita A, Wispelwey B. Community Health Worker Program Outcomes for Diabetes and Hypertension Control in West Bank Refugee Camps: A Retrospective Matched Cohort Study. Glob Health Sci Pract. 2022 Oct 31;10(5):e2200168. doi: 10.9745/GHSP-D-22-00168. Print 2022 Oct 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Vaughan, DO principal investigator
University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diabetes program in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus Risk, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the integration of the intervention (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965869, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.