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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK120895 | Other Grant/Funding Number | NIH-NIDDK |
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COVID-19
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Geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.This proposed study seeks to identify Black barbers with undiagnosed diabetes or prediabetes using point-of-care HbA1c testing, perform qualitative interviews to identify health behaviors that may explain poor sugar control, and develop a workplace-based food intervention to promote primary prevention and test its effect on sugar control in these individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention | Experimental | Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Behavioral | Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the intervention during the initial 60-day period when lunches are provided at no cost | Adherence will be calculated as the proportion of participants continuing to consume at least 80% of the lunch meals at the end of the initial intervention period when lunches will be provided at no cost. | 60 days |
| Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own | proportion of participants continue to purchase meals after the initial intervention period when individuals will be given the option to continue the intervention but paying for the lunch meals themselves. | Until the end of the two year study period |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic food and beverage diaries | Study participants will take photos of all food and beverages ingested over a 72-hourperiod to provide quantitative data on baseline dietary patterns | Baseline |
| First Point-of-care Hemoglobin A1c (HbA1c) test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Lee, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal will have access to the data. Requests should be directed to david.lee@nyumc.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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This first baseline point-of-care HbA1c test will be used as a reference.
| Baseline |
| Second Point-of-care HbA1C test | This second baseline point-of-care HbA1c test will be used to identify any changes in glycemic control that developed after initial diagnosis of diabetes or prediabetes by the first point-of-care test. | Baseline (3-6 months after first test) |
| Third Point-of-care HbA1C test | This post-treatment HbA1c test will be used to identify whether there was any short-term change in glycemic control after the dietary intervention | Post treatment (3 months after the intervention) |
| Fourth Point-of-Care HbA1c Test | This post-treatment HbA1c test will be used to identify whether there was any longer-term change in glycemic control after the dietary intervention | Post-Treatment (6 to 12 months after the intervention) |