Study protocol
Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control
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* Corresponding author: Milagros C Rosal Milagros.Rosal@umassmed.edu
1 Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655, USA
2 Department of Medicine, Division of Endocrinology, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655, USA
3 Brightwood Community Health Center/Baystate Medical Center, 380 Plainfield Street, Springfield, MA 01107, USA
4 Department of Medicine, Division of Cardiovascular Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655, USA
5 Family Health Services of Worcester, MA, 26 Queen Street, Worcester, MA 01610, USA
6 Rockingham Memorial Hospital, 100 East Grace Street, Harrisonburg, VA 22801, USA
BMC Medical Research Methodology 2009, 9:81 doi:10.1186/1471-2288-9-81
Published: 9 December 2009Abstract
Background
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.
Trial registration
http://www.clinicaltrials.gov webcite # NCT00848315