CompletedNot Applicable

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

United States60 participantsStarted 2021-11-21

Plain-language summary

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.

Who can participate

Age range

25 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 6 months

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

Timeframe: Baseline, 6 months

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

Timeframe: Baseline, 6 months

Change in Body Mass Index Over a 6-month Period

Timeframe: Baseline, 6 months

Trial details

NCT IDNCT05144737

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-16

Results submitted2026-01-28

View on ClinicalTrials.gov More Diabetes Mellitus trials

Plain-language summary

Who can participate

Age range

25 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline, 6 months

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

Timeframe: Baseline, 6 months

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

Timeframe: Baseline, 6 months

Change in Body Mass Index Over a 6-month Period

Timeframe: Baseline, 6 months