Diabetes Prevention for Black Men

Sponsor

NYU Langone Health (Other)

Overall Status

Terminated

CT.gov ID

NCT03708380

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Mar 25, 2019

Actual Primary Completion Date :

Jun 23, 2020

Actual Study Completion Date :

Jun 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.

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

Adherence to the intervention during the initial 60-day period when lunches are provided at no cost [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.
Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own [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

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03708380

Other Study ID Numbers:

18-00826
R03DK120895

First Posted:

Oct 17, 2018

Last Update Posted:

Jun 11, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Jun 11, 2021