Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Dietary intervention
Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes
Intervention: Dietary intervention (Behavioral)
Outcomes
Primary Outcomes
Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own
Time Frame: 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
Time Frame: 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 Outcomes
- First Point-of-care Hemoglobin A1c (HbA1c) test(Baseline)
- Fourth Point-of-Care HbA1c Test(Post-Treatment (6 to 12 months after the intervention))
- Photographic food and beverage diaries(Baseline)
- Second Point-of-care HbA1C test(Baseline (3-6 months after first test))
- Third Point-of-care HbA1C test(Post treatment (3 months after the intervention))