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

Sponsor
Johns Hopkins University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05144737
Collaborator
National Institute of Nursing Research (NINR) (NIH)
60
Enrollment
1
Location
2
Arms
19.3
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program
Actual Study Start Date :
Nov 21, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

ArmIntervention/Treatment
Other: Immediate Intervention Group

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
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.

Other: Delayed Intervention Group

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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).

  4. 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 (%).

  5. 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).

  6. 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 (%).

  7. 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).

  8. 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).

Secondary Outcome Measures

  1. 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%).

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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 (%).

  7. 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).

  8. 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 (%).

  9. 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).

Other Outcome Measures

  1. Change in quality of life over the 12-month period [Baseline, 6 months and 12 months]

    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.

  2. Change in pain severity over the 12-month period [Baseline, 6 months and 12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Johns Hopkins School of NursingBaltimoreMarylandUnited States21205

Sponsors and Collaborators

  • Johns Hopkins University
  • National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Yvonne Commodore-Mensah, PhD, MSH, RN, JHU School Of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT05144737
Other Study ID Numbers:
  • IRB00251726
  • 129674
First Posted:
Dec 3, 2021
Last Update Posted:
Dec 10, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 10, 2021