An interventional study of Dietary intervention in Diabetes, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 16 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes
Behavioral: Dietary intervention
Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets.
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.
Time frame: 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.
Time frame: Until the end of the two year study period
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
Time frame: Baseline
First Point-of-care Hemoglobin A1c (HbA1c) test
This first baseline point-of-care HbA1c test will be used as a reference.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Post-Treatment (6 to 12 months after the intervention)
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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