Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control
Authors
Rosal, Milagros C.White, Mary Jo
Restrepo, Angela
Olendzki, Barbara C.
Scavron, Jeffrey
Sinagra, Elise
Ockene, Ira S.
Thompson, Michael
Lemon, Stephenie C.
Candib, Lucy M.
Reed, George W.
UMass Chan Affiliations
Department of Family Medicine and Community HealthDepartment of Medicine, Division of Cardiovascular Medicine
Department of Medicine, Division of Endocrinology and Metabolism
Department of Medicine, Division of Preventive and Behavioral Medicine
Document Type
Journal ArticlePublication Date
2009-12-17Keywords
AdolescentAdult
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
Behavioral Disciplines and Activities
Behavior and Behavior Mechanisms
Community Health and Preventive Medicine
Preventive Medicine
Metadata
Show full item recordAbstract
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.Source
BMC Med Res Methodol. 2009 Dec 9;9:81. Link to article on publisher's siteDOI
10.1186/1471-2288-9-81Permanent Link to this Item
http://hdl.handle.net/20.500.14038/44958PubMed ID
20003208Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1186/1471-2288-9-81