Clinical trial NCT05144737: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in systolic blood pressure over a 6-month period
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in diastolic blood pressure over a 6-month period
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in body weight over a 6-month period
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in body fat percentage over a 6-month period
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in visceral fat over a 6-month period
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in skeletal muscle percentage over a 6-month period
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in resting metabolism over a 6-month period
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in body mass index over a 6-month period
timeFrame: Baseline, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Change in global cardiovascular disease risk
timeFrame: Baseline, 6 months and 12 months
measure: Change in body mass index over a 12-month period
timeFrame: Baseline and 12 months
measure: Change in systolic blood pressure over a 12-month period
timeFrame: Baseline and 12 months
measure: Change in diastolic blood pressure over a 12-month period
timeFrame: Baseline and 12 months
measure: Change in body weight over a 12-month period
timeFrame: Baseline and 12 months
measure: Change in body fat percentage over a 12-month period
timeFrame: Baseline and 12 months
measure: Change in visceral fat over a 12-month period
timeFrame: Baseline and 12 months
measure: Change in skeletal muscle percentage over a 12-month period
timeFrame: Baseline and 12 months
measure: Change in resting metabolism over a 12-month period
timeFrame: Baseline and 12 months
Other outcomes:
measure: Change in quality of life over the 12-month period
timeFrame: Baseline, 6 months and 12 months
measure: Change in pain severity over the 12-month period
timeFrame: Baseline, 6 months and 12 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: JHU School Of Nursing
name: Yvonne Commodore-Mensah, PhD, MSH, RN
role: PRINCIPAL_INVESTIGATOR
References: