Trial Outcomes & Findings for A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program (NCT NCT05144737)
NCT ID: NCT05144737
Last Updated: 2026-04-23
Results Overview
Change was calculated as 6 months minus the baseline value
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2026-04-23
Participant Flow
Recruitment was conducted in community-based settings, specifically African immigrant-serving churches located in the Baltimore, Maryland, and Washington, DC metropolitan area.
A total of 93 participants were assessed for eligibility, and 33 were excluded. 60 participants were consented and randomized to treatment. Participants were randomly assigned to the intervention or delayed intervention (control) group. At the end of a 6-month follow-up period, the control participants will receive the intervention (delayed intervention group).
Participant milestones
| Measure |
DPP Immediate Intervention Group First, Then no Intervention
Participants in the first intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual group sessions via videoconferencing
|
No Intervention First, Then Delayed DPP Intervention Group (6 Months)
Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group
|
|---|---|---|
|
DPP Intervention (6 Months)
STARTED
|
30
|
0
|
|
DPP Intervention (6 Months)
COMPLETED
|
20
|
0
|
|
DPP Intervention (6 Months)
NOT COMPLETED
|
10
|
0
|
|
Delayed Intervention (6 Months)
STARTED
|
0
|
30
|
|
Delayed Intervention (6 Months)
COMPLETED
|
0
|
23
|
|
Delayed Intervention (6 Months)
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immediate Intervention Group First, Then no Intervention
n=30 Participants
Participants in the first intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual group sessions via videoconferencing.
|
No Intervention First, Then Delayed Intervention Group
n=30 Participants
Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group. After 6 months, they received the identical adapted DPP lifestyle intervention as the first group, including remote monitoring.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 1.4 • n=30 Participants
|
49.7 years
STANDARD_DEVIATION 3.5 • n=30 Participants
|
50.6 years
STANDARD_DEVIATION 11.9 • n=60 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
40 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Participant's Body Mass index category
Normal
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Participant's Body Mass index category
Overweight
|
7 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Participant's Body Mass index category
Obesity
|
23 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
40 Participants
n=60 Participants
|
|
Systolic Blood Pressure
|
144.4 mmHg
STANDARD_DEVIATION 24.6 • n=30 Participants
|
148.3 mmHg
STANDARD_DEVIATION 14.6 • n=30 Participants
|
146 mmHg
STANDARD_DEVIATION 20.5 • n=60 Participants
|
|
Diastolic Blood Pressure
|
94.6 mmHg
STANDARD_DEVIATION 15.7 • n=30 Participants
|
97.5 mmHg
STANDARD_DEVIATION 14.3 • n=30 Participants
|
95.2 mmHg
STANDARD_DEVIATION 14.0 • n=60 Participants
|
|
Glycated hemoglobin (percent)
|
5.6 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.1 • n=30 Participants
|
5.3 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.1 • n=30 Participants
|
5.4 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.1 • n=60 Participants
|
|
Body Weight in kilograms (kg)
|
220.1 kg
STANDARD_DEVIATION 6.9 • n=30 Participants
|
192.4 kg
STANDARD_DEVIATION 192.4 • n=30 Participants
|
206.5 kg
STANDARD_DEVIATION 15.3 • n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsChange was calculated as 6 months minus the baseline value
Outcome measures
| Measure |
Immediate Intervention
n=20 Participants
Participants in the immediate intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual group sessions via videoconferencing
|
Delayed Intervention
n=23 Participants
Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group.
|
|---|---|---|
|
Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period
|
6.1 mmHg
Interval 2.1 to 10.0
|
10.3 mmHg
Interval 5.4 to 15.2
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsChange was calculated as 6 months minus the baseline value
Outcome measures
| Measure |
Immediate Intervention
n=20 Participants
Participants in the immediate intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual group sessions via videoconferencing
|
Delayed Intervention
n=23 Participants
Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group.
|
|---|---|---|
|
Change in Systolic Blood Pressure (mm/Hg) Over a 6-month Period
|
9.2 mmHg
Interval 2.5 to 15.9
|
11.4 mmHg
Interval 2.4 to 20.5
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsChange was calculated as 6 months minus baseline value
Outcome measures
| Measure |
Immediate Intervention
n=20 Participants
Participants in the immediate intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual group sessions via videoconferencing
|
Delayed Intervention
n=23 Participants
Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group.
|
|---|---|---|
|
Change in Body Weight in Kilograms (kg) Over a 6-month Period
|
4.9 kg
Interval 1.0 to 8.7
|
3.3 kg
Interval 0.01 to 6.5
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsChange was calculated as 6 months minus the baseline value
Outcome measures
| Measure |
Immediate Intervention
n=20 Participants
Participants in the immediate intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual group sessions via videoconferencing
|
Delayed Intervention
n=23 Participants
Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group.
|
|---|---|---|
|
Change in Body Mass Index Over a 6-month Period
|
1.1 Kg/m^2
Interval 0.4 to 1.7
|
0.3 Kg/m^2
Interval -1.5 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months and 12 monthsA 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.
Outcome measures
Outcome data not reported
Adverse Events
Immediate Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Yvonne Commodore Mensah PhD MHS, RN
Johns Hopkins University School of Nursing
Phone: 2024652551
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place