Diabetes Prevention for Black Men

NCT ID: NCT03708380

Last Updated: 2021-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-06-23

Brief Summary

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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

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Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dietary intervention

Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type BEHAVIORAL

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

Interventions

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Dietary intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Lee, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R03DK120895

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

18-00826

Identifier Type: -

Identifier Source: org_study_id

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