title: Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control.
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
  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%.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655, USA. Milagros.Rosal@umassmed.edu
authors.forename: Milagros C
authors.initials: MC
authors.lastname: Rosal
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: White
authors.forename: Angela
authors.initials: A
authors.lastname: Restrepo
authors.forename: Barbara
authors.initials: B
authors.lastname: Olendzki
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Scavron
authors.forename: Elise
authors.initials: E
authors.lastname: Sinagra
authors.forename: Ira S
authors.initials: IS
authors.lastname: Ockene
authors.forename: Michael
authors.initials: M
authors.lastname: Thompson
authors.forename: Stephenie C
authors.initials: SC
authors.lastname: Lemon
authors.forename: Lucy M
authors.initials: LM
authors.lastname: Candib
authors.forename: George
authors.initials: G
authors.lastname: Reed
mesh_terms: D000293:Adolescent; D000328:Adult; D001294:Attitude to Health / Q000208:ethnology; D003153:Community Health Services; D003376:Counseling; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000208:ethnology* / Q000628:therapy*; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin; D015438:Health Behavior / Q000208:ethnology*; D006630:Hispanic or Latino; D006801:Humans; D008404:Massachusetts; D011203:Poverty / Q000208:ethnology; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D012648:Self Care / Q000379:methods*; D014505:Urban Population; D055815:Young Adult
chemical_list: D006442:Glycated Hemoglobin