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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Demonstration and Dissemination Projects (R18)
Project #
5R18DK065985-03
Application #
7082948
Study Section
Special Emphasis Panel (ZDK1-GRB-1 (M2))
Program Officer
Garfield, Sanford A
Project Start
2004-09-01
Project End
2008-06-30
Budget Start
2006-07-01
Budget End
2007-06-30
Support Year
3
Fiscal Year
2006
Total Cost
$692,243
Indirect Cost
Name
University of Massachusetts Medical School Worcester
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603847393
City
Worcester
State
MA
Country
United States
Zip Code
01655
Wang, Monica L; Gellar, Lauren; Nathanson, Brian H et al. (2015) Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes. J Acad Nutr Diet 115:898-906
Wang, Monica L; Lemon, Stephenie C; Whited, Matthew C et al. (2014) Who benefits from diabetes self-management interventions? The influence of depression in the Latinos en Control trial. Ann Behav Med 48:256-64
Wang, Monica L; Lemon, Stephenie C; Olendzki, Barbara et al. (2013) Beverage-consumption patterns and associations with metabolic risk factors among low-income Latinos with uncontrolled type 2 diabetes. J Acad Nutr Diet 113:1695-703
Wang, Monica L; Lemon, Stephenie C; Welch, Garry et al. (2013) Development and validation of the Lifestyle Self-Efficacy Scale for Latinos with Diabetes (LSESLD). Ethn Dis 23:428-35
Ockene, Ira S; Tellez, Trinidad L; Rosal, Milagros C et al. (2012) Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino Diabetes Prevention Project. Am J Public Health 102:336-42
Lemon, Stephenie C; Rosal, Milagros C; Welch, Garry (2011) Measuring quality of life in low-income, Spanish-speaking Puerto Ricans with type 2 diabetes residing in the mainland U.S. Qual Life Res 20:1507-11
Fernandez, Senaida; Olendzki, Barbara; Rosal, Milagros C (2011) A dietary behaviors measure for use with low-income, Spanish-speaking Caribbean Latinos with type 2 diabetes: the Latino Dietary Behaviors Questionnaire. J Am Diet Assoc 111:589-99
Rosal, Milagros C; Ockene, Ira S; Restrepo, Angela et al. (2011) Randomized trial of a literacy-sensitive, culturally tailored diabetes self-management intervention for low-income latinos: latinos en control. Diabetes Care 34:838-44
Rosal, Milagros C; White, Mary Jo; Borg, Amy et al. (2010) Translational research at community health centers: challenges and successes in recruiting and retaining low-income Latino patients with type 2 diabetes into a randomized clinical trial. Diabetes Educ 36:733-49