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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05144737
• Other study ID #: IRB00251726
• Secondary ID: 129674
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 21, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• High Blood Pressure
• High Blood Sugar
• Hyperglycemia
• Hypertension
• Obesity
• Overweight
• Overweight and Obesity
• Overweight or Obesity
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in quality of life over the 12-month period	A validated tool by the name of PROMIS global measure will be provided by the Patient-Reported Outcomes Measurement Information System (PROMIS). This 9 items on this tool will measure the participants' fatigue, emotional distress, social health, and physical function. The 9 of the 10 PROMIS global measure items will be scored on a Likert scale from 1 to 5, with 5 representing the best health. Higher scores from summation of the nine items indicate better quality of life.	Baseline, 6 months and 12 months
Other	Change in pain severity over the 12-month period	A validated tool by the name of PROMIS global measure will be provided by the Patient-Reported Outcomes Measurement Information System. One item on this tool will measure the participants' perception of pain. The pain item uses a response scale of 0-10, which will be rescored to a 5-point scale. Higher scores on the Pain item indicate higher pain severity.	Baseline, 6 months and 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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