Healthy Communities Through CHW Initiatives

NCT05965869 | Active Not Recruiting DMC

• 1 other identifier: 23-0169
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus Risk

Outcome Measures

Primary Outcomes (1)

• 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

  6-months

Secondary Outcomes (1)

• Provide acceptability data of the intervention

  6-months

Study Arms (1)

Diabetes program and education

EXPERIMENTAL

Receive diabetes program and education

Other: diabetes program

Interventions

diabetes program OTHER

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

Diabetes program and education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spanish-speaking Latino(a)s adults

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Baylor College of Medicine: collaborator
• University of Houston: collaborator

Study Sites (1)

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-0158, United States

Location

Related Publications (14)

• 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.

  PMID: 36273386 BACKGROUND

• Hessler 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.

  PMID: 36205473 BACKGROUND

• Levy 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.

  PMID: 36222807 BACKGROUND

• Wagner 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.

  PMID: 36307274 BACKGROUND

• Deverts 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.

  PMID: 36192769 BACKGROUND

• Attkisson 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.

  PMID: 10259963 BACKGROUND

• Keegan 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.

  PMID: 32932865 BACKGROUND

• Garcia 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.

  PMID: 11194219 BACKGROUND

• Dumville 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.

  PMID: 16627519 BACKGROUND

• Parmanto 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.

  PMID: 27563386 BACKGROUND

• Belone 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.

  PMID: 25361792 BACKGROUND

• Rimawi 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.

  PMID: 36316145 BACKGROUND

• Vaughan 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.

  PMID: 35132555 BACKGROUND

• Vaughan 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.

  PMID: 34385148 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Vaughan, DO

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)