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

NCT ID: NCT05144737

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-21
• Study Completion Date: 2024-08-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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 This will be followed by a 6-month observation period where the intervention (Lifestyle Coach) will be withdrawn.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.

Group Type: OTHER

The Diabetes Prevention Program

Intervention Type: 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

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.

Group Type: OTHER

The Diabetes Prevention Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvonne Commodore-Mensah, PhD, MSH, RN

Role: PRINCIPAL_INVESTIGATOR

JHU School Of Nursing

Locations

Johns Hopkins School of Nursing

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40036036 (View on PubMed)

Other Identifiers

129674

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00251726

Identifier Type: -

Identifier Source: org_study_id