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NCT Number: NCT05144737

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

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.

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Key information

Conditions

Diabetes Mellitus Body Weight Cardiovascular Diseases Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders High Blood Pressure High Blood Sugar Hyperglycemia Hypertension Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Overweight or Obesity Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms Vascular Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Diabetes Prevention Program

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2021
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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