Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control

Milagros C. Rosal, University of Massachusetts Medical School
Mary Jo White, University of Massachusetts Medical School
Angela Restrepo, University of Massachusetts Medical School
Barbara C. Olendzki, University of Massachusetts Medical School
Jeffrey Scavron, Baystate Brightwood Health Center
Elise Sinagra, Rockingham Memorial Hospital
Ira S. Ockene, University of Massachusetts Medical School
Michael Thompson, University of Massachusetts Medical School
Stephenie C. Lemon, University of Massachusetts Medical School
Lucy M. Candib, University of Massachusetts Medical School
George W. Reed, University of Massachusetts Medical School

Abstract

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.