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

April 21, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Immediate Intervention Group
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
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.
Other: Delayed Intervention Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 months
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
Baseline, 6 months
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
Baseline, 6 months
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
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in global cardiovascular disease risk
Time Frame: Baseline, 6 months and 12 months
Global cardiovascular disease (CVD) risk will be calculated using the body mass index-based cardiovascular risk score. Higher scores indicate higher CVD risk. Continuous risk scores will be used to classify patients into risk categories according to the Adult Treatment Panel III of the National Cholesterol Education Program (ATPIII): low (<10%), moderate (10-20%), and high (>20%).
Baseline, 6 months and 12 months
Change in body mass index over a 12-month period
Time Frame: Baseline and 12 months
Body mass index (Kg/m^2) will be calculated using the adult body mass index calculator provided by Centers for Disease Control and Prevention.
Baseline and 12 months
Change in systolic blood pressure over a 12-month period
Time Frame: Baseline and 12 months
A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will be distributed to all participants. All participants will download the Omron Connect app which will allow them to sync their systolic blood pressure readings (mmHg) into the app.
Baseline and 12 months
Change in diastolic blood pressure over a 12-month period
Time Frame: Baseline and 12 months
A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will be distributed to all participants. All participants will download the Omron Connect app which will allow them to sync their diastolic blood pressure readings (mmHg) into the app.
Baseline and 12 months
Change in body weight over a 12-month period
Time Frame: Baseline and 12 months
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body weight (Kg).
Baseline and 12 months
Change in body fat percentage over a 12-month period
Time Frame: Baseline and 12 months
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body fat percentage (%).
Baseline and 12 months
Change in visceral fat over a 12-month period
Time Frame: Baseline and 12 months
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Visceral Fat (rating levels 1-59).
Baseline and 12 months
Change in skeletal muscle percentage over a 12-month period
Time Frame: Baseline and 12 months
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Skeletal Muscle percentage (%).
Baseline and 12 months
Change in resting metabolism over a 12-month period
Time Frame: Baseline and 12 months
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Resting Metabolism (kcal).
Baseline and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life Over the 12-month Period
Time Frame: Baseline, 6 months and 12 months
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.
Baseline, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Yvonne Commodore-Mensah, PhD, MSH, RN, JHU School Of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2021

Primary Completion (Actual)

August 16, 2024

Study Completion (Actual)

August 16, 2024

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00251726
  • 129674 (Other Grant/Funding Number: National Institute For Nursing Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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