MRC Centre for Causal Analyses in Translational Epidemiology, University of Bristol, UK.
Trials. 2011 Jul 24;12:181. doi: 10.1186/1745-6215-12-181.
Low levels of physical activity, high levels of sedentary behaviour and low levels of fruit and vegetable consumption are common in children and are associated with adverse health outcomes. The aim of this paper is to describe the protocol for a cluster randomised controlled trial (RCT) designed to evaluate a school-based intervention that aims to increase levels of physical activity, decrease sedentary behaviour and increase consumption of fruit and vegetables in school children.
METHODS/DESIGN: The Active for Life Year 5 (AFLY5) study is a school-based, cluster RCT that targets school children in Year 5 (age 9-10 years). All state junior/primary schools in the area covered by Bristol City and North Somerset Council are invited to participate; special schools are excluded. Eligible schools are randomised to one of two arms: intervention arm (receive the intervention 2011-2012) and control arm (receive the intervention after the final follow-up assessment, 2013-2014). The primary outcomes of the trial are levels of accelerometer assessed physical activity and sedentary behaviour and questionnaire assessed fruit and vegetable consumption. A number of secondary outcomes will also be measured, including body mass index, waist circumference and overweight/obesity. Outcomes will be assessed at baseline (prior to intervention when the children are in Year 4), at the end of intervention 'immediate follow-up' and '12 months long-term' follow-up. We will use random effects linear and logistic regression models to compare outcomes by randomised arm. The economic evaluation from a societal perspective will take the form of a cost consequence analysis. Data from focus groups and interviews with pupils, parents and teachers will be used to increase understanding of how the intervention has any effect and is integrated into normal school activity.
The results of the trial will provide information about the public health effectiveness of a school-based intervention aimed at improving levels of physical activity, sedentary behaviour and diet in children.
ISRCTN50133740.
儿童中普遍存在低水平的身体活动、高水平的久坐行为以及低水平的水果和蔬菜摄入，这些都与不良健康结果有关。本文旨在描述一项基于学校的干预措施的随机对照试验（RCT）的方案，该干预措施旨在提高小学生的身体活动水平、减少久坐行为并增加水果和蔬菜的摄入。
方法/设计：Active for Life Year 5（AFLY5）研究是一项基于学校的、集群随机对照试验，针对的是五年级（9-10 岁）的学生。该研究邀请了布里斯托尔市和北萨默塞特郡议会辖区内所有的州立小学/初中参与；特殊学校除外。符合条件的学校被随机分配到两个组之一：干预组（2011-2012 年接受干预）和对照组（在最后一次随访评估后，即 2013-2014 年接受干预）。试验的主要结果是使用加速度计评估的身体活动和久坐行为以及问卷调查评估的水果和蔬菜摄入量。还将测量一些次要结果，包括体重指数、腰围和超重/肥胖。结果将在基线（干预前，当孩子们在四年级时）、干预结束时的“即时随访”和 12 个月的“长期随访”进行评估。我们将使用随机效应线性和逻辑回归模型来比较随机分组的结果。从社会角度进行的经济评估将采用成本后果分析的形式。来自学生、家长和教师焦点小组和访谈的数据将用于增加对干预效果的理解，并将其纳入正常的学校活动。
该试验的结果将提供有关旨在提高儿童身体活动水平、久坐行为和饮食的基于学校的干预措施的公共卫生效果的信息。
ISRCTN50133740。
