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

NCT05144737 | Completed Results

• 1 other identifier: IRB00251726
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; PreDiabetes; Hypertension; High Blood Pressure; High Blood Sugar; Obesity; Overweight; Overweight and Obesity; Overweight or Obesity

Keywords

African immigrant; Prediabetes; National Diabetes Prevention Program

Outcome Measures

Primary Outcomes (4)

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

  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

  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

  Change was calculated as 6 months minus baseline value

  Baseline, 6 months

• Change in Body Mass Index Over a 6-month Period

  Change was calculated as 6 months minus the baseline value

  Baseline, 6 months

Other Outcomes (1)

• Change in Quality of Life Over the 12-month Period

  Baseline, 6 months and 12 months

Study Arms (2)

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.

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.

Behavioral: The Diabetes Prevention Program

Interventions

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.

Delayed Intervention Group; Immediate Intervention Group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 40036036 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Hypertension; Hyperglycemia; Obesity; Overweight

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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

Results Point of Contact

• Title: Yvonne Commodore Mensah PhD MHS, RN
• Organization: Johns Hopkins University School of Nursing

ycommod1@jhmi.edu

2024652551

Study Officials

• Yvonne Commodore-Mensah, PhD, MSH, RN

  JHU School Of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: November 21, 2021
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: April 23, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Locations

US (1)