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

Not Applicable

Completed

• Conditions: PreDiabetes; Overweight or Obesity; Obesity; Overweight; Diabetes Mellitus; High Blood Pressure; Overweight and Obesity; Diabetes Mellitus, Type 2; High Blood Sugar; Hypertension
• Interventions: Behavioral: The Diabetes Prevention Program

• Registration Number: NCT05144737
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-21
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Status Verified: 2024-08
• Primary Completion: 2024-08-16
• Study Completion: 2024-08-16
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate Intervention Group	The Diabetes Prevention Program	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.
Delayed Intervention Group	The Diabetes Prevention Program	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.

Primary Outcome Measures

Name	Time	Method
Change in body weight over a 6-month period	Baseline, 1 month, 3 months, 6 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body weight (Kg).
Change in skeletal muscle percentage over a 6-month period	Baseline, 1 month, 3 months, 6 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Skeletal Muscle percentage (%).
Change in diastolic blood pressure over a 6-month period	Baseline, 1 month, 3 months, 6 months	A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will be distributed to all participants. All participants will download the Omron Connect app which will allow them to sync their diastolic blood pressure readings (mmHg) into the app.
Change in visceral fat over a 6-month period	Baseline, 1 month, 3 months, 6 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Visceral Fat (rating levels 1-59).
Change in systolic blood pressure over a 6-month period	Baseline, 1 month, 3 months, 6 months	A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will be distributed to all participants. All participants will download the Omron Connect app which will allow them to sync their systolic blood pressure readings (mmHg) into the app.
Change in body fat percentage over a 6-month period	Baseline, 1 month, 3 months, 6 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body fat percentage (%).
Change in body mass index over a 6-month period	Baseline, 1 month, 3 months, 6 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Body Mass Index (Kg/m\^2).
Change in resting metabolism over a 6-month period	Baseline, 1 month, 3 months, 6 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Resting Metabolism (kcal).

Secondary Outcome Measures

Name	Time	Method
Change in resting metabolism over a 12-month period	Baseline and 12 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Resting Metabolism (kcal).
Change in body weight over a 12-month period	Baseline and 12 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body weight (Kg).
Change in visceral fat over a 12-month period	Baseline and 12 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Visceral Fat (rating levels 1-59).
Change in skeletal muscle percentage over a 12-month period	Baseline and 12 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Skeletal Muscle percentage (%).
Change in global cardiovascular disease risk	Baseline, 6 months and 12 months	Global cardiovascular disease (CVD) risk will be calculated using the body mass index-based cardiovascular risk score. Higher scores indicate higher CVD risk. Continuous risk scores will be used to classify patients into risk categories according to the Adult Treatment Panel III of the National Cholesterol Education Program (ATPIII): low (\<10%), moderate (10-20%), and high (\>20%).
Change in body mass index over a 12-month period	Baseline and 12 months	Body mass index (Kg/m\^2) will be calculated using the adult body mass index calculator provided by Centers for Disease Control and Prevention.
Change in systolic blood pressure over a 12-month period	Baseline and 12 months	A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will be distributed to all participants. All participants will download the Omron Connect app which will allow them to sync their systolic blood pressure readings (mmHg) into the app.
Change in diastolic blood pressure over a 12-month period	Baseline and 12 months	A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will be distributed to all participants. All participants will download the Omron Connect app which will allow them to sync their diastolic blood pressure readings (mmHg) into the app.
Change in body fat percentage over a 12-month period	Baseline and 12 months	All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body fat percentage (%).

Trial Locations

Locations (1)

Johns Hopkins School of Nursing; 🇺🇸 Baltimore, Maryland, United States