Article
Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control
Preventive and Behavioral Medicine Publications and Presentations
  • 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
UMMS Affiliation
Department 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
Date
12-17-2009
Document Type
Article
Subjects
Adolescent; 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
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.

Rights and Permissions
Citation: BMC Med Res Methodol. 2009 Dec 9;9:81. Link to article on publisher's site
Related Resources
Link to Article in PubMed
PubMed ID
20003208
Citation Information
Milagros 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/lucy_candib/79/