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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Behavioral: Dietary intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708380
|Contact: Marcela Osorio||646 501 firstname.lastname@example.org|
|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|
|Principal Investigator:||David Lee, MD||NYU Langone Health|