Diabetes Prevention for Black Men

Study Overview
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Brief Summary
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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.

Official Title
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Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Dietary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary intervention<br>Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes | Behavioral: Dietary intervention<br>* Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |