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

NCT07556354 | Not Yet Recruiting

• 2 other identifiers: IRB-300015932P50MD017338
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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; Weight Change; BMI; Diabetes Education; Diabetes (DM); Blood Pressure Monitoring

Keywords

dsmes; diabetes education; faith based intervention; remote patient monitoring

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in HbA1C results at 12 weeks

  HbA1C provides a person's average blood sugar over a 3 month period and will be measured at baseline and the end of the program via fingerprick test. The range of the test is from 4% to 14%. Normal ranges are from 4 to 5.6%, Prediabetes ranges are from 5.7% to 6.4%, Diabetes ranges are from 6.5% and above.

  From enrollment to end of treatment at 12 weeks

Secondary Outcomes (8)

• Change from Baseline in BMI at 12 weeks

  From enrollment to end of treatment at 12 weeks

• Change from Baseline in systolic blood pressure at 12 weeks

  From baseline to the end of treatment at 12 weeks

• Change from Baseline in Diastolic Blood Pressure at 12 weeks

  From enrollment to the end of treatment at 12 weeks

• Change from Baseline in Total Cholesterol at 12 weeks

  From enrollment to the end of treatment at 12 weeks

• Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at 12 weeks

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (2)

• Change in Diabetes Self-management Behaviors at Baseline and 12 weeks

  From enrollment to the end of treatment at 12 weeks

• Change in Diabetes Knowledge from Baseline and 12 weeks

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Traditional Cohort

ACTIVE COMPARATOR

Utilizes paper trackers to track blood glucose and blood pressure readings outside of DSMES sessions

Behavioral: Traditional Cohort Faith-based DSMES program

Remote Patient Monitoring (RPM) Cohort

EXPERIMENTAL

Utilizes remote patient monitoring platform to track blood pressure and blood glucose readings outside of DSMES sessions

Behavioral: Remote Patient Monitoring in a Faith-Based Program

Interventions

Remote Patient Monitoring in a Faith-Based Program BEHAVIORAL

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.

Also known as: dsmes

Remote Patient Monitoring (RPM) Cohort

Traditional Cohort Faith-based DSMES program BEHAVIORAL

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.

Also known as: faith based dsmes

Traditional Cohort

Eligibility Criteria

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

You may qualify if:

• Have a prior diabetes (Type 1, Type 2, or Gestational) or prediabetes diagnosis
• Are aged 18 or older
• Live in Jefferson County, Alabama
• Have never participated in a DSMES program

You may not qualify if:

• Not a resident of Jefferson County, Alabama
• Completed a DSMES program

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

New Hope Baptist Church

Birmingham, Alabama, 35211, United States

Location

Related Links

• Forge AHEAD Center Announces Fifth and Sixth Cohort of Scholars Focused on Advancing Cardiometabolic Health

MeSH Terms

Conditions

Body Weight Changes; Diabetes Mellitus

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Bertha Hidalgo, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dashauna Ballard, PhD

CONTACT

205-934-6553; dmball@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-03

Locations

US (1)