Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655, USA.
BMC Med Res Methodol. 2009 Dec 9;9:81. doi: 10.1186/1471-2288-9-81.
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.
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%.
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.
与非拉丁裔白人相比，美国拉丁裔人群 2 型糖尿病（糖尿病）、未得到控制的糖尿病和糖尿病合并症的患病率更高。他们的文化水平也较低，更有可能生活在贫困之中。需要采取干预措施来改善低收入拉丁裔人群的糖尿病控制情况。
本随机临床试验测试了一种针对文化和读写能力进行调整的糖尿病自我管理干预措施（拉丁裔控制）在血糖控制方面对患有糖尿病的低收入拉丁裔人群的疗效，与常规护理（对照组）相比。参与者是从马萨诸塞州的五个社区卫生中心（CHC）招募的。基于理论的干预措施包括 12 周的强化阶段和 8 个月的后续维持阶段。评估在基线、4 个月和 12 个月进行。主要结局指标是糖化血红蛋白（HbA1c）。次要结局指标包括自我管理行为、体重、血脂和血压。其他结局指标包括糖尿病知识、自我效能、抑郁和生活质量。该研究旨在招募 250 名参与者（预计 20%的辍学率），以提供 90%的效力来检测干预组和对照组之间 HbA1c 变化超过 7%或更大的情况。这是 HbA1c 变化 0.5 到 0.6%的差异。
低收入拉丁裔人群承受着未得到控制的糖尿病的巨大负担，而且是一个研究不足的人群。针对这一高危人群的需求进行调整的基于理论的干预措施有可能改善糖尿病自我管理并减少健康差距。本文描述了一项旨在满足这一需求的理论驱动干预措施的设计和方法。
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