Diabetes Mellitus, Diabetes Mellitus, Type 2, High Blood Pressure, High Blood Sugar, Hypertension, Obesity, Overweight, Overweight and Obesity, Overweight or Obesity, PreDiabetes
Conditions
Keywords
African immigrant, Prediabetes, National Diabetes Prevention Program
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.
Interventions
BEHAVIORALThe 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.
Sponsors
Johns Hopkins University
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period | 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 | 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 | Baseline, 6 months | Change was calculated as 6 months minus baseline value |
| Change in Body Mass Index Over a 6-month Period | Baseline, 6 months | Change was calculated as 6 months minus the baseline value |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYvonne Commodore-Mensah, PhD, MSH, RN
JHU School Of Nursing
Participant flow
Recruitment details
Recruitment was conducted in community-based settings, specifically African immigrant-serving churches located in the Baltimore, Maryland, and Washington, DC metropolitan area.
Pre-assignment details
A total of 93 participants were assessed for eligibility, and 33 were excluded. 60 participants were consented and randomized to treatment. Participants were randomly assigned to the intervention or delayed intervention (control) group. At the end of a 6-month follow-up period, the control participants will receive the intervention (delayed intervention group).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 11.9 |
| Body Weight in kilograms (kg) | 192.4 kg STANDARD_DEVIATION 192.4 |
| Diastolic Blood Pressure | 97.5 mmHg STANDARD_DEVIATION 14.3 |
| Glycated hemoglobin (percent) | 5.4 percentage of glycated hemoglobin STANDARD_DEVIATION 0.1 |
| Participant's Body Mass index category Normal | 1 Participants |
| Participant's Body Mass index category Obesity | 40 Participants |
| Participant's Body Mass index category Overweight | 12 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
| Systolic Blood Pressure | 148.3 mmHg STANDARD_DEVIATION 14.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
None listed