Diabetes MellitusNCT05144737

A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program

A study testing The Diabetes Prevention Program in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 75 years
Conditions the study is for: Diabetes Mellitus, Diabetes Mellitus, Type 2, PreDiabetes
What is being tested?: The Diabetes Prevention Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 21 Nov 2021to 16 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

African immigrants who are aged 25-75 years
Participants who report being uninsured or have no access to a healthcare provider
Have at least two of the following chronic conditions:
Body-mass index ≥ 25 kg/m2
Self-reported fasting plasma glucose of 95 to 125 mg/d or HbA1c of 5.7-6.5% in the past 6 months
Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg

Who cannot join

Participants who cannot communicate in English
Participants who have cognitive challenges that would restrict them from participation
Participants who have any serious illness that would interfere with participation
Participants who are not members of the churches that are involved in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins School of Nursing
Baltimore, Maryland, 21205

Other trials in United States

About this study

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.

Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2, PreDiabetes, Hypertension, High Blood Pressure, High Blood Sugar
Being tested: The Diabetes Prevention Program
Keywords: African immigrant, Prediabetes, National Diabetes Prevention Program
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2, Prediabetic State, Hypertension, Hyperglycemia, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Diabetes Prevention ProgramBehavioural
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.

Study groups in NCT05144737
Study group	Role	What they receive
Immediate Intervention Group	Other	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. Receives: Behavioral: The Diabetes Prevention Program
Delayed Intervention Group	Other	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. Receives: Behavioral: The Diabetes Prevention Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period
Change was calculated as 6 months minus the baseline value
Measured: 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
Measured: Baseline, 6 months
Change in Body Weight in Kilograms (kg) Over a 6-month Period
Change was calculated as 6 months minus baseline value
Measured: Baseline, 6 months
Change in Body Mass Index Over a 6-month Period
Change was calculated as 6 months minus the baseline value
Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202116 Aug 2024

First posted3 Dec 2021
Study start21 Nov 2021
Primary completion16 Aug 2024
Study completion16 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05144737
Sponsor's protocol ID: IRB00251726
Status last verified: Apr 2026
First submitted: 22 Nov 2021
Last updated: 23 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ogungbe O, Hinneh T, Turkson-Ocran RN, Owusu L, Kumbe B, Spaulding EM, Gbaba S, Assani-Uva A, Mensah J, Yeboah-Kordieh Y, Sinyan A, Ampofo M, Oyedepo F, Commodore-Mensah Y. A Virtual Cardiometabolic Health Program Among African Immigrants in the US: A Pilot Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e2462559. doi: 10.1001/jamanetworkopen.2024.62559.
PubMed 40036036

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program
ClinicalTrials.gov ID: NCT05144737
Acronym / sponsor ID: IRB00251726
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2, PreDiabetes, Hypertension, High Blood Pressure, High Blood Sugar
Keywords: African immigrant, Prediabetes, National Diabetes Prevention Program
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 21 Nov 2021 (actual)
Primary completion: 16 Aug 2024 (actual)
Study completion: 16 Aug 2024 (actual)
First posted: 3 Dec 2021 (actual)
Results: Posted 22 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate Intervention Group	Other	Behavioral: The Diabetes Prevention ProgramParticipants 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.
Delayed Intervention Group	Other	Behavioral: The Diabetes Prevention ProgramParticipants 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.

Who may qualify

Ages: 25 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

African immigrants who are aged 25-75 years
Participants who report being uninsured or have no access to a healthcare provider
Have at least two of the following chronic conditions:
Body-mass index ≥ 25 kg/m2
Self-reported fasting plasma glucose of 95 to 125 mg/d or HbA1c of 5.7-6.5% in the past 6 months

Key exclusion criteria (4 listed)

Participants who cannot communicate in English
Participants who have cognitive challenges that would restrict them from participation
Participants who have any serious illness that would interfere with participation
Participants who are not members of the churches that are involved in this study

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
The Diabetes Prevention ProgramThe 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.	Behavioural	Delayed Intervention Group, Immediate Intervention Group

Primary outcome

Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period
Time frame: Baseline, 6 months
Change was calculated as 6 months minus the baseline value
Change in Systolic Blood Pressure (mm/Hg) Over a 6-month Period
Time frame: Baseline, 6 months
Change was calculated as 6 months minus the baseline value
Change in Body Weight in Kilograms (kg) Over a 6-month Period
Time frame: Baseline, 6 months
Change was calculated as 6 months minus baseline value
Change in Body Mass Index Over a 6-month Period
Time frame: Baseline, 6 months
Change was calculated as 6 months minus the baseline value

Results and safety

Results posted to the registry on 22 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DPP Immediate Intervention Group First, Then no Intervention	30	20
No Intervention First, Then Delayed DPP Intervention Group (6 Months)	0	0

Primary outcome: Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period

Time frame: Baseline, 6 months. Mean (95% Confidence Interval). Unit: mmHg

Measure	Immediate Intervention n = 20	Delayed Intervention n = 23
Value	6.1 (2.1 to 10.0)	10.3 (5.4 to 15.2)

Primary outcome: Change in Systolic Blood Pressure (mm/Hg) Over a 6-month Period

Time frame: Baseline, 6 months. Mean (95% Confidence Interval). Unit: mmHg

Measure	First Intervention Group n = 20	Delayed Intervention Group n = 23
Value	9.2 (2.5 to 15.9)	11.4 (2.4 to 20.5)

Primary outcome: Change in Body Weight in Kilograms (kg) Over a 6-month Period

Time frame: Baseline, 6 months. Mean (95% Confidence Interval). Unit: kg

Measure	Immediate Intervention n = 20	Delayed Intervention n = 23
Value	4.9 (1.0 to 8.7)	3.3 (0.01 to 6.5)

Primary outcome: Change in Body Mass Index Over a 6-month Period

Time frame: Baseline, 6 months. Mean (95% Confidence Interval). Unit: Kg/m^2

Measure	First Intervention n = 20	Delayed Intervention n = 23
Value	1.1 (0.4 to 1.7)	0.3 (-1.5 to 2.0)

Adverse events

Time frame: From enrollment up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Intervention	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Delayed Intervention	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): The study had a relatively short follow-up period, a small sample size, and we could not collect information on other physical measures, such as a change in skeletal muscle percentage over a 6-month period

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40036036Ogungbe O, Hinneh T, Turkson-Ocran RN, Owusu L, Kumbe B, Spaulding EM, Gbaba S, Assani-Uva A, Mensah J, Yeboah-Kordieh Y, Sinyan A, Ampofo M, Oyedepo F, Commodore-Mensah Y. A Virtual Cardiometabolic Health Program Among African Immigrants in the US: A Pilot Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e2462559. doi: 10.1001/jamanetworkopen.2024.62559.

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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.

Yvonne Commodore-Mensah, PhD, MSH, RN principal investigator

JHU School Of Nursing

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Diabetes Prevention Program in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Johns Hopkins University 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 23 Apr 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?

Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period (time frame: Baseline, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05144737, which also lists 1 linked publication.

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 Apr 2026.