A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in body weight over a 6-month period
Study Overview
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
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: The Diabetes Prevention Program (Behavioral)
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.
Intervention: The Diabetes Prevention Program (Behavioral)
Outcomes
Primary Outcomes
Change in body weight over a 6-month period
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period
Time Frame: Baseline, 6 months
Change was calculated as 6 months minus the baseline value
Change in Systolic Blood Pressure (mm/Hg) Over a 6-month Period
Time Frame: Baseline, 6 months
Change was calculated as 6 months minus the baseline value
Change in Body Weight in Kilograms (kg) Over a 6-month Period
Time Frame: Baseline, 6 months
Change was calculated as 6 months minus baseline value
Change in Body Mass Index Over a 6-month Period
Time Frame: Baseline, 6 months
Change was calculated as 6 months minus the baseline value
Secondary Outcomes
- Change in resting metabolism over a 12-month period(Baseline and 12 months)
- Change in body weight over a 12-month period(Baseline and 12 months)
- Change in visceral fat over a 12-month period(Baseline and 12 months)
- Change in skeletal muscle percentage over a 12-month period(Baseline and 12 months)
- Change in global cardiovascular disease risk(Baseline, 6 months and 12 months)
- Change in body mass index over a 12-month period(Baseline and 12 months)
- Change in systolic blood pressure over a 12-month period(Baseline and 12 months)
- Change in diastolic blood pressure over a 12-month period(Baseline and 12 months)
- Change in body fat percentage over a 12-month period(Baseline and 12 months)