Emory Latino Diabetes Education Program

Diabetes Clinical Trial

— ELDEP  

Official title:

Emory Latino Diabetes Education Program

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00793884
• Other study ID #: IRB00013340
• Status: Suspended
• Start date: October 2008
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 3000
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• spanish speaking patients with diabetes

Exclusion Criteria:

• under 18 years of age

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia

Sponsors (5)

Lead Sponsor	Collaborator
Emory University	Eli Lilly and Company, Novo Nordisk A/S, Sanofi, Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social and Demographic Characteristics	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.	5 years
Secondary	Barriers to Health Care	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.	5 years
Secondary	Change in Blood Glucose Level	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.	Baseline, Montly Follow-up Visits (up to 5 years)
Secondary	Change in Hemoglobin A1C	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.	Baseline, Montly Follow-up Visits (up to 5 years)
Secondary	Change in Waist Circumference	Waist circumference is measured in centimeters (cm).	Baseline, Montly Follow-up Visits (up to 5 years)
Secondary	Change in Body Mass Index (BMI)	Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.	Baseline, Montly Follow-up Visits (up to 5 years)
Secondary	Change in Systolic Blood Pressure	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.	Baseline, Montly Follow-up Visits (up to 5 years)
Secondary	Change in Diastolic Blood Pressure	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.	Baseline, Montly Follow-up Visits (up to 5 years)