Williams Allison N, Konopken Yolanda P, Keller Colleen S, Castro Felipe Gonzalez, Arcoleo Kimberly J, Barraza Estela, Patrick Donald L, Olson Micah L, Shaibi Gabriel Q
Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, United States; Southwest Interdisciplinary Research Center, Arizona State University, United States.
Family Wellness Program, Virginia G. Piper, St. Vincent de Paul Medical and Dental Clinic, United States.
Contemp Clin Trials. 2017 Mar;54:68-76. doi: 10.1016/j.cct.2017.01.004. Epub 2017 Jan 16.
Type 2 diabetes (T2D) disproportionately impacts Latino youth yet few diabetes prevention programs address this important source of health disparities.
To address this knowledge gap, we describe the rationale, design, and methodology underpinning a culturally-grounded T2D prevention program for obese Latino youth. The study aims to: 1) to test the efficacy of the intervention for reducing T2D risk, 2) explore potential mediators and moderators of changes in health behaviors and health outcomes and, 3) examine the incremental cost-effectiveness for reducing T2D risk. Latino adolescents (N=160, age 14-16) will be randomized to either a 3-month intensive lifestyle intervention or a control condition. The intervention consists of weekly health education delivered by bilingual/bicultural promotores and 3 moderate-to-vigorous physical activity (PA) sessions/week. Control youth receive health information and results from their laboratory testing. Insulin sensitivity, glucose tolerance, and weight-specific quality of life are assessed at baseline, 3-months, 6-months, and 12-months. We will explore whether enhanced self-efficacy and/or social support mediate improvements in nutrition/PA behaviors and T2D outcomes. We will also explore whether effects are moderated by sex and/or acculturation. Cost-effectiveness from the health system perspective will be estimated by the incremental cost-effectiveness ratio using changes in insulin sensitivity at 12-months.
The results of this study will provide much needed information on how T2D prevention interventions for obese Latino youth are developed, implemented and evaluated. This innovative approach is an essential step in the development of scalable, cost-effective, solution oriented programs to prevent T2D in this and other high-risk populations.
2型糖尿病(T2D)对拉丁裔青少年的影响尤为严重,但很少有糖尿病预防项目能解决这一重要的健康差距问题。
为填补这一知识空白,我们描述了一项针对肥胖拉丁裔青少年的基于文化的T2D预防项目的基本原理、设计和方法。该研究旨在:1)测试干预措施降低T2D风险的效果;2)探索健康行为和健康结果变化的潜在中介因素和调节因素;3)检验降低T2D风险的增量成本效益。160名年龄在14 - 16岁的拉丁裔青少年将被随机分为3个月的强化生活方式干预组或对照组。干预措施包括由双语/双文化健康促进者每周进行的健康教育以及每周3次中度至剧烈的体育活动(PA)课程。对照组青少年接受健康信息和实验室检测结果。在基线、3个月、6个月和12个月时评估胰岛素敏感性、葡萄糖耐量和体重特异性生活质量。我们将探索增强的自我效能感和/或社会支持是否能介导营养/PA行为和T2D结果的改善。我们还将探索效果是否因性别和/或文化适应而有所不同。从卫生系统角度的成本效益将通过使用12个月时胰岛素敏感性的变化,以增量成本效益比来估计。
本研究结果将为肥胖拉丁裔青少年T2D预防干预措施的开发、实施和评估提供急需的信息。这种创新方法是开发可扩展、具有成本效益、以解决方案为导向的项目以预防该群体及其他高危人群T2D的关键一步。