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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Group | Other | 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 This will be followed by a 6-month observation period where the intervention (Lifestyle Coach) will be withdrawn.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. |
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| Delayed Intervention Group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Diabetes Prevention Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period | Change was calculated as 6 months minus the baseline value | Baseline, 6 months |
| Change in Systolic Blood Pressure (mm/Hg) Over a 6-month Period | Change was calculated as 6 months minus the baseline value | Baseline, 6 months |
| Change in Body Weight in Kilograms (kg) Over a 6-month Period | Change was calculated as 6 months minus baseline value | Baseline, 6 months |
| Change in Body Mass Index Over a 6-month Period | Change was calculated as 6 months minus the baseline value | Baseline, 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Over the 12-month Period | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Commodore-Mensah, PhD, MSH, RN | JHU School Of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Nursing | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40036036 | Derived | Ogungbe O, Hinneh T, Turkson-Ocran RN, Owusu L, Kumbe B, Spaulding EM, Gbaba S, Assani-Uva A, Mensah J, Yeboah-Kordieh Y, Sinyan A, Ampofo M, Oyedepo F, Commodore-Mensah Y. A Virtual Cardiometabolic Health Program Among African Immigrants in the US: A Pilot Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e2462559. doi: 10.1001/jamanetworkopen.2024.62559. |
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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).
Recruitment was conducted in community-based settings, specifically African immigrant-serving churches located in the Baltimore, Maryland, and Washington, DC metropolitan area.
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| ID | Title | Description |
|---|---|---|
| FG000 | DPP Immediate Intervention Group First, Then no Intervention | Participants in the first intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual group sessions via videoconferencing |
| FG001 | No Intervention First, Then Delayed DPP Intervention Group (6 Months) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DPP Intervention (6 Months) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2021 |
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| Baseline, 6 months and 12 months |
Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group |
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| NOT COMPLETED |
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| Delayed Intervention (6 Months) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention Group First, Then no Intervention | Participants in the first intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual group sessions via videoconferencing. |
| BG001 | No Intervention First, Then Delayed Intervention Group | Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group. After 6 months, they received the identical adapted DPP lifestyle intervention as the first group, including remote monitoring. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Participant's Body Mass index category | Count of Participants | Participants | No |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Glycated hemoglobin (percent) | Mean | Standard Deviation | percentage of glycated hemoglobin |
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| Body Weight in kilograms (kg) | Mean | Standard Deviation | kg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Diastolic Blood Pressure (mm/Hg) Over a 6-month Period | Change was calculated as 6 months minus the baseline value | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, 6 months |
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| Primary | Change in Systolic Blood Pressure (mm/Hg) Over a 6-month Period | Change was calculated as 6 months minus the baseline value | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, 6 months |
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| Primary | Change in Body Weight in Kilograms (kg) Over a 6-month Period | Change was calculated as 6 months minus baseline value | Posted | Mean | 95% Confidence Interval | kg | Baseline, 6 months |
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| Primary | Change in Body Mass Index Over a 6-month Period | Change was calculated as 6 months minus the baseline value | Posted | Mean | 95% Confidence Interval | Kg/m^2 | Baseline, 6 months |
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| Other Pre-specified | Change in Quality of Life Over the 12-month Period | 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. | Not Posted | Baseline, 6 months and 12 months | Participants |
From enrollment up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Intervention | Participants in the first intervention group immediately began the 6-month adapted DPP lifestyle intervention, which included weekly 60-minute virtual meeting. | 0 | 60 | 0 | 60 | 0 | 60 |
| EG001 | Delayed Intervention | Participants in the delayed intervention group received no lifestyle intervention during the first 6 months but underwent the same assessments as the first intervention group | 0 | 60 | 0 | 60 | 0 | 60 |
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The study had a relatively short follow-up period, a small sample size, and we could not collect information on other physical measures, such as a change in skeletal muscle percentage over a 6-month period
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvonne Commodore Mensah PhD MHS, RN | Johns Hopkins University School of Nursing | 2024652551 | ycommod1@jhmi.edu |
| Jan 28, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D006973 | Hypertension |
| D006943 | Hyperglycemia |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Overweight |
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| Obesity |
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