Objective To assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity.
Design Cluster randomised controlled trial.
Setting UK primary schools from the West Midlands.
Participants 200 schools were randomly selected from all state run primary schools within 35 miles of the study centre (n=980), oversampling those with high minority ethnic populations. These schools were randomly ordered and sequentially invited to participate. 144 eligible schools were approached to achieve the target recruitment of 54 schools. After baseline measurements 1467 year 1 pupils aged 5 and 6 years (control: 28 schools, 778 pupils) were randomised, using a blocked balancing algorithm. 53 schools remained in the trial and data on 1287 (87.7%) and 1169 (79.7%) pupils were available at first follow-up (15 month) and second follow-up (30 month), respectively.
Interventions The 12 month intervention encouraged healthy eating and physical activity, including a daily additional 30 minute school time physical activity opportunity, a six week interactive skill based programme in conjunction with Aston Villa football club, signposting of local family physical activity opportunities through mail-outs every six months, and termly school led family workshops on healthy cooking skills.
Main outcome measures The protocol defined primary outcomes, assessed blind to allocation, were between arm difference in body mass index (BMI) z score at 15 and 30 months. Secondary outcomes were further anthropometric, dietary, physical activity, and psychological measurements, and difference in BMI z score at 39 months in a subset.
Results Data for primary outcome analyses were: baseline, 54 schools: 1392 pupils (732 controls); first follow-up (15 months post-baseline), 53 schools: 1249 pupils (675 controls); second follow-up (30 months post-baseline), 53 schools: 1145 pupils (621 controls). The mean BMI z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference −0.075 (95% confidence interval −0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was −0.027 (−0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm).
Conclusions The primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments.
Trial registration Current Controlled Trials ISRCTN97000586.

中文翻译：

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通过针对6岁和7岁儿童的学校提供​​的儿童肥胖预防计划的有效性：整群随机对照试验（WAVES研究）

目的与常规做法相比，评估以学校和家庭为基础的健康生活方式计划（WAVES干预）在预防儿童肥胖方面的有效性。
设计群随机对照试验。在西米德兰兹郡
设置英国小学。
参加者从研究中心35英里（n = 980）内的所有国立小学中随机选择了200所学校，对那些少数民族人口较多的学校进行了超采样。这些学校被随机命令并依次受邀参加。与144所合格学校进行了接触，以实现54所学校招募的目标。在基线测量后，使用封闭平衡算法将1467年的5岁和6岁的1年级学生（对照组：28所学校，778名学生）随机分组。53所学校仍在试验中，在第一次随访（15个月）和第二次随访（30个月）时分别有1287（87.7％）和1169（79.7％）名学生的数据。
干预措施为期12个月的干预措施鼓励健康饮食和体育锻炼，包括每天额外增加30分钟的上课时间体育锻炼机会，与阿斯顿维拉足球俱乐部联合进行的为期六周的基于互动技能的计划，通过邮寄方式张贴当地家庭体育锻炼机会的路标六个月，然后由学校定期领导有关健康烹饪技能的家庭研讨会。
主要结局指标协议定义的主要结局指标（在分配时不知情）在15个月和30个月时的体重指数（BMI）z评分差异之间。次要结果是进一步的人体测量，饮食，身体活动和心理测量，以及一个子集中39个月时BMI z得分的差异。
结果主要结果分析的数据是：基线，54所学校：1392名学生（732名对照）；第一次随访（基线后15个月），53所学校：1249名学生（675名对照）；第二次随访（基线后30个月），53所学校：1145名学生（621名对照）。在基线调整模型中，干预组在15个月时的平均BMI z得分与对照组相比无显着降低（均值-0.075（95％置信区间-0.183至0.033，P = 0.18），在30个月时。平均差异为-0.027（-0.137 0.083，P = 0.63），但对于其他人体，饮食，身体活动，或心理测量（包括危害评估），组间差异无统计学显著差异。
结论初步分析表明，这种以体验为重点的干预措施对BMI z评分或预防儿童肥胖没有统计学上的显着影响。如果没有在多个部门和环境中提供更广泛的支持，学校不大可能通过纳入此类干预措施来影响儿童肥胖病的流行。
试用注册当前控制的试用ISRCTN97000586。