Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City

NCT07556354 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-11

No results posted yet for this study

Summary

In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.

Conditions

  • Blood Cholesterol
  • Blood Pressure Monitoring
  • Weight Change
  • BMI
  • Diabetes Education
  • Diabetes (DM)

Interventions

BEHAVIORAL

Remote Patient Monitoring in a Faith-Based Program

Participants will be randomly-assigned to one of two cohorts. One cohort will participate in a faith-based DSMES program and use remote patient monitoring (RPM) to track their health throughout the duration. Remote patient monitoring allows a participant's healthcare team to visualize and monitor health data outside of scheduled DSMES sessions. These participants will be given blood pressure and blood glucose tracking devices that utilize Bluetooth to automatically upload their health data into an RPM platform, Prevounce, once measurements are taken.

BEHAVIORAL

Traditional Cohort Faith-based DSMES program

The Traditional Cohort will also participate in the DSMES program but instead will be provided traditional blood pressure cuffs and glucometers that will not upload their data to a mobile platform to track their health data. These participants will use traditional means (paper trackers) to track their health data and will provide health updates during scheduled communication with community health workers.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Bertha Hidalgo, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556354 on ClinicalTrials.gov