Adab Peymane, Pallan Miranda J, Lancashire Emma R, Hemming Karla, Frew Emma, Griffin Tania, Barrett Timothy, Bhopal Raj, Cade Janet E, Daley Amanda, Deeks Jonathan, Duda Joan, Ekelund Ulf, Gill Paramjit, McGee Eleanor, Parry Jayne, Passmore Sandra, Cheng Kar Keung
Health & Population Sciences, University of Birmingham, B15 2TT, Birmingham, UK.
School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
BMC Public Health. 2015 May 13;15:488. doi: 10.1186/s12889-015-1800-8.
There is some evidence that school-based interventions are effective in preventing childhood obesity. However, longer term outcomes, equity of effects and cost-effectiveness of interventions have not been assessed. The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools, in preventing obesity in 6-7 year old children, compared to usual practice.
This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a multi-ethnic, socioeconomically diverse population of children aged 6-7 years. The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase time spent doing physical activity within the school day, participation in the 'Villa Vitality' programme (a programme that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents and children, and provision of information to families signposting local leisure opportunities. The primary (clinical) outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC ≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for pre-specified baseline school and child level covariates.
The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multi-ethnic population, with a sufficient sample size to detect clinically important differences in adiposity. The intervention was developed using the Medical Research Council framework for complex interventions, and outcomes are measured objectively, together with a comprehensive process evaluation.
Current Controlled Trials ISRCTN97000586 (registered May 2010).
有证据表明，以学校为基础的干预措施在预防儿童肥胖方面是有效的。然而，干预措施的长期效果、效果的公平性以及成本效益尚未得到评估。本试验的目的是评估一项通过小学针对学校和家庭环境的多成分干预计划，与常规做法相比，在预防6至7岁儿童肥胖方面的临床效果和成本效益。
这项整群随机对照试验在英国西米德兰兹郡的54所小学进行，纳入了6至7岁、多民族、社会经济背景多样的儿童。为期12个月的干预措施包括促进健康饮食和体育活动。这些措施包括：增加在校期间体育活动时间的活动、参与“活力别墅”计划（由一个标志性体育机构（阿斯顿维拉足球俱乐部）实施的计划，该计划提供体育活动和健康饮食的互动学习机会）、在学校时间为家长和孩子举办健康烹饪技能工作坊，以及向家庭提供当地休闲机会的信息。主要（临床）结局是干预完成后3个月和18个月时两组之间体重指数（BMI）z评分的差异。还将评估每质量调整生命年（QALY）的成本。样本量估计（随访时1000名儿童分在50所学校）基于90%的检验效能，以检测BMI z评分0.25的差异（估计组内相关系数≤0.04），假设基线和随访BMI z评分之间的相关性为0.9。将使用混合模型协方差分析来检验治疗效果。主要分析将调整基线BMI z评分，次要分析将调整预先指定的基线学校和儿童水平协变量。
西米德兰兹郡在校儿童积极生活方式与健康饮食（WAVES）研究是第一项将在多民族人群中检验儿童肥胖预防计划的成本效益和长期效果的试验，样本量足以检测肥胖方面具有临床意义的差异。该干预措施是根据医学研究理事会复杂干预框架制定的，结局采用客观测量，并进行全面的过程评估。
当前受控试验ISRCTN97000586（2010年5月注册）。
