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

BMC Med Res Methodol. 2009 Dec 9;9:81. doi: 10.1186/1471-2288-9-81.

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.

Trial registration: ClinicalTrials.gov NCT00848315.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Attitude to Health / ethnology
  • Community Health Services
  • Counseling
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / ethnology*
  • Diabetes Mellitus, Type 2 / therapy*
  • Follow-Up Studies
  • Glycated Hemoglobin
  • Health Behavior / ethnology*
  • Hispanic or Latino*
  • Humans
  • Massachusetts
  • Poverty / ethnology
  • Randomized Controlled Trials as Topic / methods
  • Research Design
  • Self Care / methods*
  • Urban Population
  • Young Adult

Substances

  • Glycated Hemoglobin A

Associated data

  • ClinicalTrials.gov/NCT00848315