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

Primary Purpose

Diabetes Mellitus, Diabetes Mellitus, Type 2, PreDiabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Diabetes Prevention Program
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring African immigrant, Prediabetes, National Diabetes Prevention Program

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Immediate Intervention Group

Delayed Intervention Group

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 This will be followed by a 6-month observation period where the intervention (Lifestyle Coach) will be withdrawn.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

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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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 (%).
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).
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 (%).
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).
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).

Secondary Outcome Measures

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%).
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.
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.
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.
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).
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 (%).
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).
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 (%).
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).

Full Information

First Posted
November 22, 2021
Last Updated
April 10, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05144737
Brief Title
A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program
Official Title
A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 2, PreDiabetes, Hypertension, High Blood Pressure, High Blood Sugar, Obesity, Overweight, Overweight and Obesity, Overweight or Obesity
Keywords
African immigrant, Prediabetes, National Diabetes Prevention Program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention Group
Arm Type
Other
Arm 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.
Arm Title
Delayed Intervention Group
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
The Diabetes Prevention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in systolic blood pressure over a 6-month period
Description
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.
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in diastolic blood pressure over a 6-month period
Description
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.
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in body weight over a 6-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body weight (Kg).
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in body fat percentage over a 6-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body fat percentage (%).
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in visceral fat over a 6-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Visceral Fat (rating levels 1-59).
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in skeletal muscle percentage over a 6-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Skeletal Muscle percentage (%).
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in resting metabolism over a 6-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Resting Metabolism (kcal).
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in body mass index over a 6-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Body Mass Index (Kg/m^2).
Time Frame
Baseline, 1 month, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in global cardiovascular disease risk
Description
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%).
Time Frame
Baseline, 6 months and 12 months
Title
Change in body mass index over a 12-month period
Description
Body mass index (Kg/m^2) will be calculated using the adult body mass index calculator provided by Centers for Disease Control and Prevention.
Time Frame
Baseline and 12 months
Title
Change in systolic blood pressure over a 12-month period
Description
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.
Time Frame
Baseline and 12 months
Title
Change in diastolic blood pressure over a 12-month period
Description
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.
Time Frame
Baseline and 12 months
Title
Change in body weight over a 12-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body weight (Kg).
Time Frame
Baseline and 12 months
Title
Change in body fat percentage over a 12-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body fat percentage (%).
Time Frame
Baseline and 12 months
Title
Change in visceral fat over a 12-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Visceral Fat (rating levels 1-59).
Time Frame
Baseline and 12 months
Title
Change in skeletal muscle percentage over a 12-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Skeletal Muscle percentage (%).
Time Frame
Baseline and 12 months
Title
Change in resting metabolism over a 12-month period
Description
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures Resting Metabolism (kcal).
Time Frame
Baseline and 12 months
Other Pre-specified Outcome Measures:
Title
Change in quality of life over the 12-month period
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in pain severity over the 12-month period
Description
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.
Time Frame
Baseline, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Commodore-Mensah, PhD, MSH, RN
Organizational Affiliation
JHU School Of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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

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