Diabetes Prevention for Black Men

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03708380
• Other study ID #: 18-00826
• Secondary ID: R03DK120895
• Status: Terminated
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: June 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 23, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	First Point-of-care Hemoglobin A1c (HbA1c) test	This first baseline point-of-care HbA1c test will be used as a reference.	Baseline
Secondary	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)
Secondary	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)
Secondary	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)