MedPath

Diabetes Prevention for Black Men

Not Applicable
Terminated
Conditions
Diabetes
Interventions
Behavioral: Dietary intervention
Registration Number
NCT03708380
Lead Sponsor
NYU Langone Health
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
16
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Dietary interventionDietary interventionCommunity-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes
Primary Outcome Measures
NameTimeMethod
Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their ownUntil 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.

Adherence to the intervention during the initial 60-day period when lunches are provided at no cost60 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.

Secondary Outcome Measures
NameTimeMethod
First Point-of-care Hemoglobin A1c (HbA1c) testBaseline

This first baseline point-of-care HbA1c test will be used as a reference.

Fourth Point-of-Care HbA1c TestPost-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

Photographic food and beverage diariesBaseline

Study participants will take photos of all food and beverages ingested over a 72-hourperiod to provide quantitative data on baseline dietary patterns

Second Point-of-care HbA1C testBaseline (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 testPost 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

Trial Locations

Locations (1)

New York University School of Medicine

🇺🇸

New York, New York, United States

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