Diabetes Prevention for Black Men

NYU Langone Health16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Diabetes

Interventions

Dietary interventionBEHAVIORAL

Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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