An interventional study of Remote Patient Monitoring in a Faith-Based Program and Traditional Cohort Faith-based DSMES program in Blood Cholesterol, Blood Pressure Monitoring and Weight Change, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
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.
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.
231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 179 interventional studies indexed under Body Weight Changes.
Browse Body Weight Changes studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
Utilizes paper trackers to track blood glucose and blood pressure readings outside of DSMES sessions
Behavioral: Traditional Cohort Faith-based DSMES program
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.
Also known as: dsmes
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
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.
Time frame: From enrollment to end of treatment at 12 weeks
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.
Time frame: 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-.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks
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).
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: Undecided — 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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