Diabetes
Conditions
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.
Interventions
BEHAVIORALDietary intervention
Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
| First Point-of-care Hemoglobin A1c (HbA1c) test | Baseline | This first baseline point-of-care HbA1c test will be used as a reference. |
Countries
United States
Outcome results
None listed