- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00793884
Emory Latino Diabetes Education Program (ELDEP)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Emory University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- spanish speaking patients with diabetes
Exclusion Criteria:
- under 18 years of age
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
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.
|
Baseline, Montly Follow-up Visits (up to 5 years)
|
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.
|
Baseline, Montly Follow-up Visits (up to 5 years)
|
Change in Waist Circumference
Time Frame: Baseline, Montly Follow-up Visits (up to 5 years)
|
Waist circumference is measured in centimeters (cm).
|
Baseline, Montly Follow-up Visits (up to 5 years)
|
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.
|
Baseline, Montly Follow-up Visits (up to 5 years)
|
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.
|
Baseline, Montly Follow-up Visits (up to 5 years)
|
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.
|
Baseline, Montly Follow-up Visits (up to 5 years)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ina Flores, MS, RN, CDE, LD, Emory University
- Principal Investigator: Guillermo Umpierrez, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00013340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom