Diabetes Prevention for Black Men
- Conditions
- Diabetes
- Interventions
- Behavioral: Dietary intervention
- Registration Number
- NCT03708380
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- Black or African American men who work as barbers at Black-owned barbershops
- Barbershop clients.
- Workplace in neighborhood geographically identified as having higher diabetes burden
- No prior history of clinical diagnosis of diabetes
- Identified on initial and second point-of-care testing to have an HbA1c of 5.7 or greater
- Individuals with a history of blood loss or blood disorder that would lead to incorrect results on point-of care HbA1c testing
- Individuals with a history of food allergies that requires specific dietary restrictions
- Individuals who are not English speaking
- Individuals who have a significant cognitive impairment that will be a barrier to communication, valid consent and participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dietary intervention Dietary intervention Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes
- Primary Outcome Measures
Name Time Method Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own Until the end of the two year study period 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.
Adherence to the intervention during the initial 60-day period when lunches are provided at no cost 60 days 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.
- Secondary Outcome Measures
Name Time Method First Point-of-care Hemoglobin A1c (HbA1c) test Baseline This first baseline point-of-care HbA1c test will be used as a reference.
Fourth Point-of-Care HbA1c Test Post-Treatment (6 to 12 months after the intervention) This post-treatment HbA1c test will be used to identify whether there was any longer-term change in glycemic control after the dietary intervention
Photographic food and beverage diaries Baseline Study participants will take photos of all food and beverages ingested over a 72-hourperiod to provide quantitative data on baseline dietary patterns
Second Point-of-care HbA1C test Baseline (3-6 months after first 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.
Third Point-of-care HbA1C test Post treatment (3 months after the intervention) This post-treatment HbA1c test will be used to identify whether there was any short-term change in glycemic control after the dietary intervention
Trial Locations
- Locations (1)
New York University School of Medicine
🇺🇸New York, New York, United States