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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: The Diabetes Prevention Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Immediate Intervention Group<br>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<br>* 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.<br>|
| Other: Delayed Intervention Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure over a 6-month period | 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. | Baseline, 1 month, 3 months, 6 months | 
| Change in diastolic blood pressure over a 6-month period | 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. | Baseline, 1 month, 3 months, 6 months | 
| Change in body weight over a 6-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body weight (Kg). | Baseline, 1 month, 3 months, 6 months | 
| Change in body fat percentage over a 6-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body fat percentage (%). | Baseline, 1 month, 3 months, 6 months | 
| Change in visceral fat over a 6-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Visceral Fat (rating levels 1-59). | Baseline, 1 month, 3 months, 6 months | 
| Change in skeletal muscle percentage over a 6-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Skeletal Muscle percentage (%). | Baseline, 1 month, 3 months, 6 months | 
| Change in resting metabolism over a 6-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Resting Metabolism (kcal). | Baseline, 1 month, 3 months, 6 months | 
| Change in body mass index over a 6-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Body Mass Index (Kg/m^2). | Baseline, 1 month, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global cardiovascular disease risk | 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%). | Baseline, 6 months and 12 months | 
| Change in body mass index over a 12-month period | Body mass index (Kg/m^2) will be calculated using the adult body mass index calculator provided by Centers for Disease Control and Prevention. | Baseline and 12 months | 
| Change in systolic blood pressure over a 12-month period | 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. | Baseline and 12 months | 
| Change in diastolic blood pressure over a 12-month period | 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. | Baseline and 12 months | 
| Change in body weight over a 12-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body weight (Kg). | Baseline and 12 months | 
| Change in body fat percentage over a 12-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body fat percentage (%). | Baseline and 12 months | 
| Change in visceral fat over a 12-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Visceral Fat (rating levels 1-59). | Baseline and 12 months | 
| Change in skeletal muscle percentage over a 12-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Skeletal Muscle percentage (%). | Baseline and 12 months | 
| Change in resting metabolism over a 12-month period | All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Resting Metabolism (kcal). | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetes, African immigrant, National Diabetes Prevention Program