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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: BMI; Diabetes (DM); Weight Change; Blood Cholesterol; Diabetes Education; Blood Pressure Monitoring
• Intervention / Treatment: Behavioral: Traditional Cohort Faith-based DSMES program; Behavioral: Remote Patient Monitoring in a Faith-Based Program

Detailed Description

Participants in this study will take part in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center. 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, they will complete questionnaires that assess 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 will be collected. This data will also be collected again after the completion of the program. MedsPLUS Consulting are licensed pharmacists skilled in conducting biometric screenings and will assist in the collection of the clinical data. MedsPLUS Consulting will also be responsible for disposing of the biospecimens collected for the study through use of the SHARPS program.

In this study, DSMES participants will be randomly-assigned to one of two cohorts. One cohort will participate in the 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. The second 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 the team. One community health worker (two total) will be assigned to each cohort to monitor the progress of the participants. These community health workers will contact participants outside of scheduled DSMES sessions to assess barriers that may hinder progress.The results of these interactions will be shared with MedsPLUS Consulting and the study team.

As a means of assessing the barriers for implementation for the entire faith-based DSMES program that incorporates RPM, DSMES participants, leadership from the faith-based organization, community health workers, and MedsPLUS Consulting will be asked to participate in focus groups or semi-structured interviews.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dashauna Ballard, PhD; Phone Number: 205-934-6553; Email: dmball@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • New Hope Baptist Church
      • Contact: Dashauna M Ballard, PhD; Phone Number: 205-934-6553; Email: dmball@uab.edu
      • Contact: Sabrina Famuyiwa, MPH; Email: sfamuyiw@uab.edu
      • Principal Investigator: Dashauna Ballard, PhD
      • Principal Investigator: Bertha Hidalgo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Cohort; Utilizes paper trackers to track blood glucose and blood pressure readings outside of DSMES sessions	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.; Other Names: faith based dsmes
Experimental: Remote Patient Monitoring (RPM) Cohort; 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; 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.; Other Names: dsmes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in BMI at 12 weeks	BMI is a screening tool that uses a person's height and weight to estimate their body fat and overall health risk. BMI will be calculated using the participant's height and weight data at baseline and end of program.	From enrollment to end of treatment at 12 weeks
Change from Baseline in systolic blood pressure at 12 weeks	Systolic blood pressure measures the force against artery walls when the heart contracts, with a normal reading below 120 mmHg. The change in this outcome will be measured via blood pressure cuff pre- and post-.	From baseline to the end of treatment at 12 weeks
Change from Baseline in Diastolic Blood Pressure at 12 weeks	Diastolic blood pressure measures arterial pressure when the heart rests between beats and will be assessed via blood pressure cuff reading at baseline and end of program. A normal reading is less than 80 mmHg.	From enrollment to the end of treatment at 12 weeks
Change from Baseline in Total Cholesterol at 12 weeks	Total cholesterol measures the overall amount of cholesterol in the blood and will be assessed via blood sample at baseline and end of program. A desirable level is less than 200 mg/dL.	From enrollment to the end of treatment at 12 weeks
Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at 12 weeks	Low-density lipoprotein (LDL) cholesterol, often referred to as "bad" cholesterol, contributes to plaque buildup in arteries and will be assessed via blood sample at baseline and end of program. An optimal level is less than 100 mg/dL.	From enrollment to the end of treatment at 12 weeks
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at 12 weeks	High-density lipoprotein (HDL) cholesterol, often referred to as "good" cholesterol, helps remove excess cholesterol from the bloodstream and will be assessed via blood sample at baseline and end of program. A desirable level is 60 mg/dL or higher.	From enrollment to the end of treatment at 12 weeks
Change from Baseline in Triglycerides at 12 weeks	Triglycerides measure the amount of fat in the blood and will be assessed via blood sample at baseline and end of program. A normal level is less than 150 mg/dL.	From enrollment to the end of treatment at 12 weeks
Change from Baseline in Body Weight at 12 weeks	Body weight measures total body mass and will be assessed using a calibrated scale at baseline and end of program. It is reported in pounds.	From enrollment to the end of treatment at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Self-management Behaviors at Baseline and 12 weeks	Diabetes Self-Management Behaviors will be assessed using the Diabetes Self-Management Questionnaire-Revised at Baseline and 12 weeks. Scores are calculated on a scale of 0-10 for the total score. Scores less than 5 for any of the measure's subcales suggest a need for improvement in the respective area (e.g. eating behavior, medication taking, glucose monitoring, physical activity, and cooperation with diabetes care team).	From enrollment to the end of treatment at 12 weeks
Change in Diabetes Knowledge from Baseline and 12 weeks	Diabetes Knowledge will be assessed from Baseline to 12 weeks utilizing the Diabetes Knowledge Questionnaire-Revised. The diabetes knowledge questionnaire revised is scored from 0-22 with higher scores indicating higher diabetes knowledge and lesser scores indicating lesser diabetes knowledge. There is not an official cutoff criteria for the scores reported.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Bertha Hidalgo, PhD, University of Alabama at Birmingham

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: remote patient monitoring; diabetes education; dsmes; faith based intervention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Body Weight; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus; Body Weight Changes; Health Services Administration; Delivery of Health Care; Telemedicine; Patient Care Management; Remote Patient Monitoring
• Other Study ID Numbers: IRB-300015932; P50MD017338 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study team is currently evaluating plans for data and document sharing. Considerations include ongoing manuscript development, participant confidentiality, and institutional guidelines. A final determination will be made following completion of primary analyses and dissemination activities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No