Blood CholesterolMCPILOTDSMESNCT07556354
Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City
A study testing Remote Patient Monitoring in a Faith-Based Program and Traditional Cohort Faith-based DSMES program in people with Blood Cholesterol and Blood Pressure Monitoring, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Cholesterol, Blood Pressure Monitoring, Weight Change
- What is being tested?
- Remote Patient Monitoring in a Faith-Based Program and Traditional Cohort Faith-based DSMES program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a resident of Jefferson County, Alabama
- Completed a DSMES program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Cholesterol, Blood Pressure Monitoring, Weight Change, BMI, Diabetes Education, Diabetes (DM)
- Being tested
- Remote Patient Monitoring in a Faith-Based Program, Traditional Cohort Faith-based DSMES program
- Keywords
- dsmes, diabetes education, faith based intervention, remote patient monitoring
- Medical subject headings
- Body Weight Changes, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient Monitoring in a Faith-Based ProgramBehavioural
Also called dsmes
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.
Traditional Cohort Faith-based DSMES programBehavioural
Also called faith based 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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Cohort | Active comparator | Utilizes paper trackers to track blood glucose and blood pressure readings outside of DSMES sessions Receives: 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 Receives: Behavioral: Remote Patient Monitoring in a Faith-Based Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of treatment at 12 weeks
Secondary outcomes (8)
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.
Measured: 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-.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start26 Aug 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CholesterolStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Bertha Hidalgo, University of Alabama at Birmingham
- Investigators
- Bertha Hidalgo, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556354
- Sponsor's protocol ID
- IRB-300015932
- Other IDs
- P50MD017338
- Acronym
- MCPILOTDSMES
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City: A Pilot Study
- ClinicalTrials.gov ID
- NCT07556354
- Acronym / sponsor ID
- MCPILOTDSMES / IRB-300015932
- Conditions
- Blood Cholesterol, Blood Pressure Monitoring, Weight Change, BMI, Diabetes Education, Diabetes (DM)
- Keywords
- dsmes, diabetes education, faith based intervention, remote patient monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Cohort | Active comparator | Behavioral: Traditional Cohort Faith-based DSMES programUtilizes paper trackers to track blood glucose and blood pressure readings outside of DSMES sessions |
| Remote Patient Monitoring (RPM) Cohort | Experimental | Behavioral: Remote Patient Monitoring in a Faith-Based ProgramUtilizes remote patient monitoring platform to track blood pressure and blood glucose readings outside of DSMES sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not a resident of Jefferson County, Alabama
- Completed a DSMES program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Patient Monitoring in a Faith-Based ProgramAlso: dsmesParticipants 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. | Behavioural | Remote Patient Monitoring (RPM) Cohort |
| Traditional Cohort Faith-based DSMES programAlso: faith based dsmesThe 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. | Behavioural | Traditional Cohort |
Primary outcome
Change from Baseline in HbA1C results at 12 weeks
Time frame: From enrollment to end of treatment 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.
8 secondary outcomes
Change from Baseline in BMI at 12 weeks
Time frame: From enrollment to end of treatment at 12 weeks
Change from Baseline in systolic blood pressure at 12 weeks
Time frame: From baseline to the end of treatment at 12 weeks
Change from Baseline in Diastolic Blood Pressure at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change from Baseline in Total Cholesterol at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change from Baseline in Triglycerides at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Change from Baseline in Body Weight at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Forge AHEAD Center Announces Fifth and Sixth Cohort of Scholars Focused on Advancing Cardiometabolic HealthLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertha Hidalgo, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring in a Faith-Based Program and Traditional Cohort Faith-based DSMES program in people with Blood Cholesterol and Blood Pressure Monitoring, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in HbA1C results at 12 weeks (time frame: From enrollment to end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.