Type 2 Diabetes, Glycemic Control
Conditions
Keywords
cognitive behavioral intervention, low literate/illiterate Hispanic patients
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavioral 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 patients.
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is improvement in metabolic control (HbA1c). | The primary outcome was evaluated at 4- and 12-months following randomization. |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of the intervention | 4- and 12-months following the intervention |
Countries
United States
Outcome results
None listed