Clinical trial NCT00793884: Emory Latino Diabetes Education Program
Official title: Emory Latino Diabetes Education Program
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Diabetes
Keywords: Diabetes
Latino population
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Eli Lilly and Company
name: Takeda
name: Novo Nordisk A/S
First posted: 2008-11-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spanish speaking patients with Diabetes

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).

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.

Eligibility criteria: Inclusion Criteria:

* spanish speaking patients with diabetes

Exclusion Criteria:

* under 18 years of age

Primary outcomes:
measure: Social and Demographic Characteristics
timeFrame: 5 years
Secondary outcomes:
measure: Barriers to Health Care
timeFrame: 5 years
measure: Change in Blood Glucose Level
timeFrame: Baseline, Montly Follow-up Visits (up to 5 years)
measure: Change in Hemoglobin A1C
timeFrame: Baseline, Montly Follow-up Visits (up to 5 years)
measure: Change in Waist Circumference
timeFrame: Baseline, Montly Follow-up Visits (up to 5 years)
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, Montly Follow-up Visits (up to 5 years)
measure: Change in Systolic Blood Pressure
timeFrame: Baseline, Montly Follow-up Visits (up to 5 years)
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline, Montly Follow-up Visits (up to 5 years)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
Study officials:
affiliation: Emory University
name: Ina Flores, MS, RN, CDE, LD
role: STUDY_DIRECTOR
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: