The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention (CBI) designed to enhance adherence to diabetes self-management behaviors and thus improve glycemic control (HbA1c) among low-income Hispanic individuals with type 2 diabetes mellitus (T2DM). The study population will consist of 250 Hispanic patients (pts) recruited from two community health centers (CHCs) serving low-income, primarily minority communities in central and western Massachusetts. Pts will be randomly assigned to a Usual Care (UC) condition in which pts are provided with usual care only, or to the Cognitive Behavioral Intervention (CBI) condition. The unit of randomization and analysis will be the pt. The intervention will be implemented by a nutritionist, a nurse diabetes educator and an assistant, and pts will be encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. The intervention will emphasize pts' 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 will be delivered utilizing strategies and materials appropriate for low-literate/illiterate pts. The primary outcome to be evaluated at 4-and 12-months following randomization is improvement in metabolic control (HbA1c). Secondary aims include the evaluation of the efficacy of the program on: 1) Adherence to self-management behaviors (i.e., recommendations for diet, physical activity (PA), self-monitoring of blood glucose (SMBG), and medication intake); 2) Other relevant factors including LDL cholesterol, blood pressure (BP), body mass index (BMI) and quality of life (QoL). We also will evaluate the association of demographic and psychosocial factors to self-management behaviors and HbA1c and to changes in these, and will determine the cost (per pt) of implementing the intervention. The proposed study has been successfully pilot-tested in the target population and preliminary results are promising. The study products (i.e., detailed intervention manual, tailored educational materials, manual for training of providers) will serve to enhance the translation potential of the intervention.
