Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en ControlPreventive and Behavioral Medicine Publications and Presentations
UMMS AffiliationDepartment of Medicine, Division of Preventive and Behavioral Medicine; Department of Medicine, Division of Endocrinology and Metabolism; Department of Medicine, Division of Cardiovascular Medicine; Department of Family Medicine and Community Health
SubjectsAdolescent; Adult; Attitude to Health; Community Health Services; Counseling; Diabetes Mellitus, Type 2; Follow-Up Studies; Health Behavior; Hemoglobin A, Glycosylated; *Hispanic Americans; Humans; Massachusetts; Poverty; Randomized Controlled Trials as Topic; Research Design; Self Care; Urban Population; Young Adult
AbstractBACKGROUND: US Latinos have greater prevalence of type 2 diabetes (diabetes), uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos. METHODS AND DESIGN: This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control) on glycemic control among low-income Latinos with diabetes, compared to usual care (control). Participants were recruited from five community health centers (CHCs) in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c). Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate) to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%. DISCUSSION: Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need.
Rights and PermissionsCitation: BMC Med Res Methodol. 2009 Dec 9;9:81. Link to article on publisher's site
Related ResourcesLink to Article in PubMed
Citation InformationMilagros C. Rosal, Mary Jo White, Angela Restrepo, Barbara C. Olendzki, et al.. "Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control" Vol. 9 (2009) ISSN: 1471-2288 (Linking)
Available at: http://works.bepress.com/jeffrey-scavron/5/