A cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6-7 year old children: the WAVES study protocol.
A cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6-7 year old children: the WAVES study protocol.
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DOI：
10.1186/s12889-015-1800-8
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发表时间：
2015-05-13
影响因子：
4.5
通讯作者：
Cheng KK
中科院分区：
文献类型：
--
作者：
Adab P;Pallan MJ;Lancashire ER;Hemming K;Frew E;Griffin T;Barrett T;Bhopal R;Cade JE;Daley A;Deeks J;Duda J;Ekelund U;Gill P;McGee E;Parry J;Passmore S;Cheng KK
有一些证据表明，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，还没有对干预措施的长期结果、效果公平和成本效益进行评估。这项试验的目的是评估通过小学以学校和家庭环境为目标的多成分干预方案在预防6-7岁儿童肥胖方面的临床和成本效益，与通常做法相比。这项分组随机对照试验在英国西米德兰兹郡的54所小学进行，其中包括6-7岁的多种族、社会经济多样化的儿童。为期12个月的干预包括健康饮食和促进体育活动。这些活动包括：增加在校期间进行体育锻炼的时间的活动；参与“Villa Vitality”计划(该计划由一个标志性的体育机构(阿斯顿维拉足球俱乐部)提供互动的体育活动和健康饮食机会)；为家长和孩子在学校时间举办健康烹饪技能讲习班；以及向宣传当地休闲机会的家庭提供信息。主要(临床)结果是干预完成后3个月和18个月时ARM之间的体重指数(BMI)z评分的差异。还将评估每质量调整寿命年(QALY)的成本。样本量估计(50所学校的1,000名儿童在跟进时)是基于90%的能力来检测体重指数z分数的差异0.25(估计国际商会≤为0.04)，假设基线和后续体重指数z分数之间的相关性为0.9%。治疗效果将使用混合模型ANCOVA进行检验。初级分析将根据基线BMI z得分进行调整，二级分析将根据预先指定的基线学校和儿童水平协变量进行调整。西米德兰兹郡学龄儿童积极生活方式和健康饮食(WAVE)研究是第一项试验，将在多种族人口中检验儿童肥胖症预防计划的成本效益和长期结果，并有足够的样本量来发现肥胖症的临床重要差异。干预措施是利用医学研究理事会的复杂干预措施框架制定的，结果是客观衡量的，并进行了全面的过程评估。当前对照试验ISRCTN97000586(注册于2010年5月)。
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).
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影响因子：
1.3
作者：
Mattu, GS;Heran, BS;Wright, JM
通讯作者：
Wright, JM
影响因子：
4.1
作者：
Corder, Kirsten;Brage, Soren;Ekelund, Ulf
通讯作者：
Ekelund, Ulf
影响因子：
4.8
作者：
Hemming, Karla;Marsh, Jen
通讯作者：
Marsh, Jen
影响因子：
4.7
作者：
Brage, S;Brage, N;Wareham, NJ
通讯作者：
Wareham, NJ
影响因子：
158.5
作者：
Baker, Jennifer L.;Olsen, Lina W.;Sorensen, Thorkild I. A.
通讯作者：
Sorensen, Thorkild I. A.