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Trial record 22 of 88 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

Diabetes Prevention for Black Men

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ClinicalTrials.gov Identifier: NCT03708380
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Dietary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : March 25, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adherence to the intervention during the initial 60-day period when lunches are provided at no cost [ Time Frame: 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.

  2. Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own [ Time Frame: 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 :
  1. Photographic food and beverage diaries [ Time Frame: Baseline ]
    Study participants will take photos of all food and beverages ingested over a 72-hourperiod to provide quantitative data on baseline dietary patterns

  2. First Point-of-care Hemoglobin A1c (HbA1c) test [ Time Frame: Baseline ]
    This first baseline point-of-care HbA1c test will be used as a reference.

  3. Second Point-of-care HbA1C test [ Time Frame: 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.

  4. Third Point-of-care HbA1C test [ Time Frame: 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

  5. Fourth Point-of-Care HbA1c Test [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708380


Contacts
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Contact: Marcela Osorio 646 501 6810 marcela.osorio@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Marcela Osorio    646-501-6810      
Principal Investigator: David Lee, MD         
Sponsors and Collaborators
NYU Langone Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: David Lee, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03708380     History of Changes
Other Study ID Numbers: 18-00826
R03DK120895 ( Other Grant/Funding Number: NIH-NIDDK )
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases