Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, UK.
Peninsula Clinical Trials Unit and Medical Statistics, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
Lancet Child Adolesc Health. 2018 Jan;2(1):35-45. doi: 10.1016/S2352-4642(17)30151-7.
Although childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9-10 years would prevent excessive weight gain after 24 months.
This pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one more than one) and the proportion of children eligible for free school meals (<19% [the national average] ≥19%). HeLP was delivered to year-5 children (ages 9-10 years) over 1 year, and included dynamic and interactive activities such as physical activity workshops, education sessions delivered by teachers with short homework tasks, drama sessions, and setting goals to modify behaviour (with parental support and one-to-one discussions with HeLP coordinators). The primary outcome was change in body-mass index (BMI) standard deviation score (SDS) between baseline and 24 months, analysed in children with BMI data available for both timepoints. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN15811706, and the trial status is complete.
Between March 21, 2012, and Sept 30, 2013, 32 eligible schools with 1324 children were recruited, of which 16 schools (676 children) were randomly assigned to the HeLP intervention and 16 schools (648 children) to control. All schools that began the trial completed the intervention, and 1244 children (628 in intervention group and 616 in control group) had BMI data at both baseline and 24 months for the primary outcome analysis. Mean BMI SDS was 0·32 (SD 1·16) at baseline and 0·35 (1·25) at 24 months in the intervention group, and 0·18 (1·14) at baseline and 0·22 (1·22) at 24 months in the control group. With adjustment for school-level clustering, baseline BMI scores, sex, cohort, and number of year-5 classes and socioeconomic status of each school, the mean difference in BMI SDS score (intervention-control) at 24 months was -0·02 (95% CI -0·09 to 0·05), p=0·57. One parent reported an adverse event related to their child's eating and activity behaviours, but agreed for the child to continue trial participation after discussion with the chief investigator.
Despite a theoretically informed and extensively piloted intervention that achieved high levels of engagement, follow-up, and fidelity of delivery, we found no effect of the intervention on preventing overweight or obesity. Although schools are an ideal setting in which to deliver population-based interventions, school-based interventions might not be sufficiently intense to affect both the school and the family environment, and hence the weight status of children. Future research should focus on more upstream determinants of obesity and use whole-systems approaches.
UK National Institute for Health Research, Public Health Research Programme.
在过去的三十年中，尽管全球儿童超重和肥胖的患病率大幅上升，但有效的预防策略证据仍然很少。我们旨在确定一项针对 9-10 岁儿童的基于学校的干预措施是否会在 24 个月后预防体重过度增加。
这项实用的基于学校的肥胖预防干预措施——健康生活方式计划（HeLP）的随机对照试验，在英格兰西南部的 32 所学校进行。德文郡和普利茅斯（英国）所有符合条件的国立小学和初中都有足够的学生，至少有一个五年级班。学校按照计算机生成的序列（按五年级班的数量（一个以上）和有资格获得免费校餐的儿童比例（<19%[全国平均水平]≥19%）进行 1:1 分配，随机分配到干预组或对照组。HeLP 在 1 年内提供给五年级的孩子（9-10 岁），包括动态和互动活动，如体育活动工作坊、由教师提供的教育课程，包括短期作业任务、戏剧课程和设定目标以改变行为（在父母的支持下，以及与 HeLP 协调员进行一对一讨论）。主要结局是在基线和 24 个月之间 BMI 标准差评分（SDS）的变化，对在两个时间点均有 BMI 数据的儿童进行分析。这项研究在国际随机对照试验注册中心注册，编号为 ISRCTN15811706，试验状态为完成。
2012 年 3 月 21 日至 2013 年 9 月 30 日期间，有 32 所符合条件的学校有 1324 名儿童参加，其中 16 所学校（676 名儿童）被随机分配到 HeLP 干预组，16 所学校（648 名儿童）被分配到对照组。所有开始试验的学校都完成了干预，在主要结局分析中，有 1244 名儿童（干预组 628 名，对照组 616 名）在基线和 24 个月时有 BMI 数据。干预组的 BMI SDS 平均值在基线时为 0.32（SD 1.16），在 24 个月时为 0.35（1.25），对照组在基线时为 0.18（1.14），在 24 个月时为 0.22（1.22）。在校级聚类、基线 BMI 评分、性别、队列和每个学校五年级班级的数量以及社会经济地位进行调整后，24 个月时 BMI SDS 评分（干预-对照组）的平均差异为-0.02（95%CI-0.09 至 0.05），p=0.57。一位家长报告了与孩子饮食和活动行为有关的不良事件，但在与首席研究员讨论后，同意让孩子继续参加试验。
尽管干预措施具有理论依据并经过广泛的试点，但参与度高、随访和实施的一致性高，但我们没有发现干预措施对预防超重或肥胖有任何影响。尽管学校是实施基于人群的干预措施的理想场所，但基于学校的干预措施可能强度不够，无法影响学校和家庭环境，从而影响儿童的体重。未来的研究应集中于肥胖的上游决定因素，并采用全系统方法。
英国国家健康研究所，公共卫生研究计划。
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