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Emory Latino Diabetes Education Program (ELDEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00793884
Recruitment Status : Recruiting
First Posted : November 19, 2008
Last Update Posted : November 21, 2019
Sponsor:
Collaborators:
Sanofi
Eli Lilly and Company
Takeda
Novo Nordisk A/S
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Brief Summary:
Latinos with diabetes who are attending the Emory Latino Diabetes education program will be approached about consenting to have clinical measurements collected to assess changes between baseline and monthly follow up sessions. The no-cost educational sessions follow the self-care behavior curriculum of the American Association of Diabetes Educators (AADE).

Condition or disease
Diabetes

Detailed Description:

Latinos represent the largest minority group in the United States with a population of 35 million or 12.5%. National surveys indicate that the prevalence of type 2 diabetes is 1.9 times higher in Latinos than non-whites, and that approximately 24% percent of Latinos over the age of 45 years have diabetes. In Georgia, Latinos make up approximately 6.5% of the population. During 1990 and 2000, the prevalence of diabetes in Fulton and Dekalb counties, two of the most populated areas in Georgia and the Atlanta metropolitan area increased by 30%. Language and cultural barriers represent the two most important obstacles in educating and improving the care of Latino patients with diabetes. Less than 5% of physicians, 2% of nurses, and 2.5% of dentists in the US speak Spanish.

The Emory Latino Diabetes education program has been in existence since December 2005. This program aims to deliver diabetes education in Spanish to the underserved Latino community in Metro Atlanta. Program participants attend an initial 3 hour diabetes education class in Spanish. The class curriculum follows the American Association of Diabetes Educators (AADE) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. Participants are invited to return to a follow-up session within 6 months. Follow-up sessions are held in the late afternoon. These sessions are discussion-based and include an activity such as salsa lessons and cooking demonstrations. Diabetes education classes and follow-up sessions are offered at Grady Memorial Hospital (Diabetes Clinic, International Medical Center), Grady North Dekalb Clinic (Chamblee), and North Fulton Regional Hospital.

Participants complete a questionnaire assessing behaviors and social and demographic characteristics of the Latino community being served. Hemoglobin A1C, blood pressure, weight, body mass index (BMI) and waist circumference will be measured at the beginning of each class. This study will analyze and publish data collected from individuals who are attending the educational sessions. Additionally, the researchers will collect retrospective data from past participants in the program.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Emory Latino Diabetes Education Program
Study Start Date : October 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort
Diabetes Education
Latino individuals with diabetes who are attending the Emory Latino Diabetes Education Program (ELDEP) will be followed in order to collect outcomes on clinical measurements. The class curriculum follows the American Association of Diabetes Educators (AADE) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. Program participants attend an initial 3 hour diabetes education class conducted in Spanish and then are invited to return to monthly follow-up sessions covering topics of meal planning, exercise, medications and complications. The follow-up sessions include activities such as dance lessons, cooking demonstrations, and sharing.



Primary Outcome Measures :
  1. Social and Demographic Characteristics [ Time Frame: 5 years ]
    One aim of this study is to describe the social and demographic characteristics of the Latino population with diabetes mellitus in Georgia. Participants will complete a qualitative demographic survey including questions regarding medical care received, physical activity, medications taken and blood sugar monitoring habits.


Secondary Outcome Measures :
  1. Barriers to Health Care [ Time Frame: 5 years ]
    To examine barriers to health care among Latinos with Diabetes in the population served participants will be asked qualitative questions about what type of health insurance they have and if they have a physician that they see.

  2. Change in Blood Glucose Level [ Time Frame: Baseline, Montly Follow-up Visits (up to 5 years) ]
    Blood glucose levels are measured in milligrams of glucose per deciliter of blood (mg/dL). Normal fasting levels are between 70 and 99 mg/dL and diabetes is indicated when fasting glucose levels are greater than 125 mg/dL.

  3. Change in Hemoglobin A1C [ Time Frame: Baseline, Montly Follow-up Visits (up to 5 years) ]
    The hemoglobin A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.

  4. Change in Waist Circumference [ Time Frame: Baseline, Montly Follow-up Visits (up to 5 years) ]
    Waist circumference is measured in centimeters (cm).

  5. Change in Body Mass Index (BMI) [ Time Frame: Baseline, Montly Follow-up Visits (up to 5 years) ]
    Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.

  6. Change in Systolic Blood Pressure [ Time Frame: Baseline, Montly Follow-up Visits (up to 5 years) ]
    Blood pressure will be measured using blood pressure monitor. Normal systolic blood pressure is less than 120 millimeter of mercury (mm/Hg) and high blood pressure is typically diagnosed at measurements of 130 mm/Hg and higher.

  7. Change in Diastolic Blood Pressure [ Time Frame: Baseline, Montly Follow-up Visits (up to 5 years) ]
    Blood pressure will be measured using blood pressure monitor. Normal diastolic blood pressure is less than 80 mm/Hg and high blood pressure is typically diagnosed at measurements of 80 mm/Hg and higher.



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
Sampling Method:   Non-Probability Sample
Study Population
Spanish speaking patients with Diabetes
Criteria

Inclusion Criteria:

  • spanish speaking patients with diabetes

Exclusion Criteria:

  • under 18 years of age

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): NCT00793884


Contacts
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Contact: Ina Flores, MS, RN, CDE, LD 404.251.8976 ina.flores@emory.edu
Contact: Guillermo Umpierrez, MD 4048871665 geumpie@emory.edu

Locations
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United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30303
Contact: Ina Flores, MS, RD, CDE, LD    404-251-8976    ina.flores@emory.edu   
Principal Investigator: Guillermo Umpierrez, MD         
Sponsors and Collaborators
Emory University
Sanofi
Eli Lilly and Company
Takeda
Novo Nordisk A/S
Investigators
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Study Director: Ina Flores, MS, RN, CDE, LD Emory University
Principal Investigator: Guillermo Umpierrez, MD Emory University

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Responsible Party: Guillermo Umpierrez, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00793884    
Other Study ID Numbers: IRB00013340
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guillermo Umpierrez, MD, Emory University:
Diabetes
Latino population
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases