An interventional study of The Diabetes Prevention Program in Diabetes Mellitus, Diabetes Mellitus, Type 2 and PreDiabetes, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
A pilot study titled "A Virtual Cardiometabolic Health Program for African Immigrants (The Afro-DPP Program) will be conducted to address the cardiometabolic of community-dwelling African immigrants who have multiple cardiometabolic risk factors including hypertension, Type 2 Diabetes, high cholesterol, and overweight/obesity. The proposed study will recruit a total of 60 participants and will use a non-equivalent control group design to test the effectiveness of the intervention at two African churches in the Baltimore, Washington, D.C. area. The two churches will be randomly assigned to the intervention or delayed intervention group. At the end of a 6-month follow-up period, the control church will receive the intervention (delayed control group). All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body composition including Body Weight, Body Fat percentage, Visceral Fat, Skeletal Muscle percentage, Resting Metabolism and Body Mass Index. A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will also be distributed to all participants. All participants will download the Omron Connect app which will allow the participants to sync participants' blood pressure readings and body composition readings into the app. The research team will access these readings to monitor study outcomes and participants progress during the follow-up period.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
Participants in the immediate intervention group will immediately begin 6 months of the adapted DPP lifestyle intervention with a Lifestyle Coach and remote monitoring of blood pressure and body composition. This will be followed by a 6-month observation period where the intervention (Lifestyle Coach) will be withdrawn. In this period, participants will be evaluated for the maintenance of lifestyle changes.
Behavioral: The Diabetes Prevention Program
Participants in the delayed intervention group will receive remote monitoring of blood pressure and body composition for the 1st 6 months (without the Lifestyle Coach) and then will receive the adapted DPP lifestyle intervention with a Lifestyle Coach after 6 months.
Behavioral: The Diabetes Prevention Program
The multicomponent intervention will focus on intensive lifestyle modification delivered by the Lifestyle Coach. The Lifestyle Coach of African origin will be responsible for delivering the intensive lifestyle intervention and implementing the adapted diabetes prevention program (DPP) curriculum.
Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period
Change was calculated as 6 months minus the baseline value
Time frame: Baseline, 6 months
Change in Systolic Blood Pressure (mm/Hg) Over a 6-month Period
Change was calculated as 6 months minus the baseline value
Time frame: Baseline, 6 months
Change in Body Weight in Kilograms (kg) Over a 6-month Period
Change was calculated as 6 months minus baseline value
Time frame: Baseline, 6 months
Change in Body Mass Index Over a 6-month Period
Change was calculated as 6 months minus the baseline value
Time frame: Baseline, 6 months
Change in Quality of Life Over the 12-month Period
A validated tool by the name of PROMIS global measure will be provided by the Patient-Reported Outcomes Measurement Information System (PROMIS). This 9 items on this tool will measure the participants' fatigue, emotional distress, social health, and physical function. The 9 of the 10 PROMIS global measure items will be scored on a Likert scale from 1 to 5, with 5 representing the best health. Higher scores from summation of the nine items indicate better quality of life.
Time frame: Baseline, 6 months and 12 months
Recruitment was conducted in community-based settings, specifically African immigrant-serving churches located in the Baltimore, Maryland, and Washington, DC metropolitan area.
| Milestone | DPP Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed DPP Intervention Group (6 Months) |
|---|---|---|
| Started | 30 | 0 |
| Completed | 20 | 0 |
| Not completed | 10 | 0 |
| Milestone | DPP Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed DPP Intervention Group (6 Months) |
|---|---|---|
| Started | 0 | 30 |
| Completed | 0 | 23 |
| Not completed | 0 | 7 |
Change was calculated as 6 months minus the baseline value
| mmHg | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period | 6.1 (2.1 to 10.0) | 10.3 (5.4 to 15.2) |
Change was calculated as 6 months minus the baseline value
| mmHg | First Intervention Group | Delayed Intervention Group |
|---|---|---|
| Change in Systolic Blood Pressure (mm/Hg) Over a 6-month Period | 9.2 (2.5 to 15.9) | 11.4 (2.4 to 20.5) |
Change was calculated as 6 months minus baseline value
| kg | Immediate Intervention | Delayed Intervention |
|---|---|---|
| Change in Body Weight in Kilograms (kg) Over a 6-month Period | 4.9 (1.0 to 8.7) | 3.3 (0.01 to 6.5) |
Change was calculated as 6 months minus the baseline value
| Kg/m^2 | First Intervention | Delayed Intervention |
|---|---|---|
| Change in Body Mass Index Over a 6-month Period | 1.1 (0.4 to 1.7) | 0.3 (-1.5 to 2.0) |
A validated tool by the name of PROMIS global measure will be provided by the Patient-Reported Outcomes Measurement Information System (PROMIS). This 9 items on this tool will measure the participants' fatigue, emotional distress, social health, and physical function. The 9 of the 10 PROMIS global measure items will be scored on a Likert scale from 1 to 5, with 5 representing the best health. Higher scores from summation of the nine items indicate better quality of life.
Results for this outcome have not been posted.
Collected over From enrollment up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Intervention | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Delayed Intervention | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(years) | Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed Intervention Group | Total |
|---|---|---|---|
| Mean | 51.1 ± 1.4 | 49.7 ± 3.5 | 50.6 ± 11.9 |
| Sex: Female, Male(Participants) | Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed Intervention Group | Total |
|---|---|---|---|
| Female | 24 | 16 | 40 |
| Male | 6 | 14 | 20 |
| Race and Ethnicity Not Collected(Participants) | Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed Intervention Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Participant's Body Mass index category(Participants) | Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed Intervention Group | Total |
|---|---|---|---|
| Normal | 0 | 1 | 1 |
| Overweight | 7 | 12 | 19 |
| Obesity | 23 | 17 | 40 |
| Systolic Blood Pressure(mmHg) | Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed Intervention Group | Total |
|---|---|---|---|
| Mean | 144.4 ± 24.6 | 148.3 ± 14.6 | 146 ± 20.5 |
| Diastolic Blood Pressure(mmHg) | Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed Intervention Group | Total |
|---|---|---|---|
| Mean | 94.6 ± 15.7 | 97.5 ± 14.3 | 95.2 ± 14.0 |
| Glycated hemoglobin (percent)(percentage of glycated hemoglobin) | Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed Intervention Group | Total |
|---|---|---|---|
| Mean | 5.6 ± 0.1 | 5.3 ± 0.1 | 5.4 ± 0.1 |
| Body Weight in kilograms (kg)(kg) | Immediate Intervention Group First, Then no Intervention | No Intervention First, Then Delayed Intervention Group | Total |
|---|---|---|---|
| Mean | 220.1 ± 6.9 | 192.4 ± 192.4 | 206.5 ± 15.3 |
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