Diabetes Prevention for Black Men

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

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 Overview

• Status: Terminated
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Dietary intervention

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: David Lee, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 18-00826; R03DK120895 (Other Grant/Funding Number: NIH-NIDDK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal will have access to the data. Requests should be directed to david.lee@nyumc.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No