Diabetes Prevention for Black Men

• ClinicalTrials.gov Identifier: NCT03708380
• Recruitment Status: Terminated
• First Posted: October 17, 2018
• Last Update Posted: June 11, 2021
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes	Behavioral: Dietary intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes
• Actual Study Start Date: March 25, 2019
• Actual Primary Completion Date: June 23, 2020
• Actual Study Completion Date: June 23, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. Photographic food and beverage diaries [ Time Frame: Baseline ]
   Study participants will take photos of all food and beverages ingested over a 72-hourperiod to provide quantitative data on baseline dietary patterns
2. First Point-of-care Hemoglobin A1c (HbA1c) test [ Time Frame: Baseline ]
   This first baseline point-of-care HbA1c test will be used as a reference.
3. Second Point-of-care HbA1C test [ Time Frame: 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.
4. Third Point-of-care HbA1C test [ Time Frame: 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
5. Fourth Point-of-Care HbA1c Test [ Time Frame: 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: David Lee, MD; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03708380
• Other Study ID Numbers: 18-00826; R03DK120895 ( Other Grant/Funding Number: NIH-NIDDK )
• First Posted: October 17, 2018
• Last Update Posted: June 11, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases