Diabetes Prevention for Black Men

NCT03708380 | Terminated

• 2 other identifiers: 18-00826R03DK120895
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Photographic food and beverage diaries

  Baseline

• First Point-of-care Hemoglobin A1c (HbA1c) test

  Baseline

• Second Point-of-care HbA1C test

  Baseline (3-6 months after first test)

• Third Point-of-care HbA1C test

  Post treatment (3 months after the intervention)

• Fourth Point-of-Care HbA1c Test

  Post-Treatment (6 to 12 months after the intervention)

Study Arms (1)

Dietary intervention

EXPERIMENTAL

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

Behavioral: Dietary intervention

Interventions

Dietary intervention BEHAVIORAL

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

Dietary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• David Lee, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: October 17, 2018
• Study Start: March 25, 2019
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)