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首页> 外文期刊>Preventive Medicine: An International Journal Devoted to Practice and Theory >Design, implementation, and quality control in the Pathways American-Indian multicenter trial.
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Design, implementation, and quality control in the Pathways American-Indian multicenter trial.

机译：Pathways美洲印第安人多中心试验中的设计，实施和质量控制。

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BACKGROUND: Pathways was the first multicenter American-Indian school-based study to test the effectiveness of an obesity prevention program promoting healthy eating and physical activity. METHODS: Pathways employed a nested cohort design in which 41 schools were randomized to intervention or control conditions and students within these schools were followed as a cohort (1,704 third graders at baseline). The study's primary endpoint was percent body fat. Secondary endpoints were levels of fat in school lunches; time spent in physical activity; and knowledge, attitudes, and behaviors regarding diet and exercise. Quality control (QC) included design of data management systems which provided standardization and quality assurance of data collection and processing. Data QC procedures at study centers included manuals of operation, training and certification, and monitoring of performance. Process evaluation was conducted to monitor dose and fidelity of the interventions. Registration and tracking systems were used for students and schools. RESULTS: No difference in mean percent body fat at fifth grade was found between the intervention and control schools. Percent of calories from fat and saturated fat in school lunches was significantly reduced in the intervention schools as was total energy intake from 24-hour recalls. Significant increases in self-reported physical activity levels and knowledge of healthy behaviors were found for the intervention school students. CONCLUSIONS: The Pathways study results provide evidence demonstrating the role schools can play in public health promotion. Its study design and QC systems and procedures provide useful models for other similar school based multi- or single-site studies.
机译：背景：Pathways是第一项基于多中心美国印第安人学校的研究，旨在测试肥胖预防计划促进健康饮食和体育锻炼的有效性。方法：途径采用嵌套式队列设计，其中41所学校被随机分配到干预或控制条件下，并以这些学校中的学生为队列（基准为1,704个三年级学生）。该研究的主要终点是体内脂肪百分比。次要终点是学校午餐中的脂肪水平;在体育锻炼上花费的时间;以及有关饮食和运动的知识，态度和行为。质量控制（QC）包括数据管理系统的设计，该系统提供了数据收集和处理的标准化和质量保证。研究中心的数据质量控制程序包括操作，培训和认证手册以及性能监控手册。进行过程评估以监测干预的剂量和保真度。注册和跟踪系统用于学生和学校。结果：干预学校和对照学校之间五年级的平均体脂百分比没有差异。干预学校的午餐中来自脂肪和饱和脂肪的卡路里百分比显着降低，而24小时召回的总能量摄入也显着降低。干预学校的学生发现自我报告的体育活动水平和健康行为知识显着增加。结论：衔接课程的研究结果提供了证据，证明了学校在促进公共卫生方面可以发挥的作用。它的研究设计，质量控制系统和程序为其他基于学校的类似的多站点或单站点研究提供了有用的模型。

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