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

Johns Hopkins University

Status: Completed

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

Treatments: Behavioral: The Diabetes Prevention Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05144737

IRB00251726

129674 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Immediate Intervention Group

Other group

Description:

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.

Treatment:

Behavioral: The Diabetes Prevention Program

Delayed Intervention Group

Other group

Description:

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.

Treatment:

Behavioral: The Diabetes Prevention Program