Diabetes Management in Low-Income Hispanic Patients
Diabetes Management in Low-Income Hispanic Patients
The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a
 culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance
 adherence to diabetes self-management behaviors and improve glycemic control among low-income
 Hispanic individuals with type 2 diabetes mellitus.
Patients are randomly assigned to a Usual Care condition or to the Cognitive Behavioral
 Intervention condition. The unit of randomization and analysis is the patient. The
 intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant,
 and patients are encouraged to bring a family member or friend living in the same household
 to facilitate home-based support for the intervention. The intervention emphasizes patients'
 ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and
 the use of available community resources (e.g., available areas for exercise), and is
 delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.
Inclusion Criteria:

 1. Diagnosed with T2DM (documented in the medical chart);

 2. HbA1c level > 7.5;

 3. Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin,
 must have a history of prior therapy with diet alone or oral hypoglycemic agents;

 4. Hispanic origin;

 5. > 18 years old;

 6. Telephone in home or easy access to one;

 7. Able to understand and participate in the study protocol;

 8. Functionally capable of meeting the activity goals;

 9. Understands and can provide informed consent (English or Spanish; for illiterate pts
 we will require that a representative of the pt also understands and signs the consent
 form on behalf of the pt);

 10. Physician approval to participate in the study.

 Exclusion Criteria:

 1. History of diabetic ketoacidosis

 2. Gestational diabetes

 3. Unable or unwilling to provide informed consent;

 4. Plans to move out of the area within the 12-month study period;

 5. Required intermittent glucocorticoid therapy within the past 3 months;

 6. Experienced an acute coronary event (myocardial infarction or unstable angina) within
 the previous 6 mos

 7. Has a medical condition that precludes adherence to study dietary recommendations
 (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease);

 8. Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or
 suicidality within past 5 years or takes an atypical neuroleptic medication). We will
 not exclude individuals with a diagnosis of depression or pts taking anti-depressants.