Data from: EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children

Objectives: To assess the reproducibility of an educational intervention EdAl-2 (Educació en Alimentació) programme in ‘Terres de l'Ebre’ (Spain), over 22 months, to improve lifestyles, including diet and physical activity (PA). Design: Reproduction of a cluster randomised controlled trial. Setting: Two semi-rural town-group primary-school clusters were randomly assigned to the intervention or control group. Participants: Pupils (n=690) of whom 320 constituted the intervention group (1 cluster) and 370 constituted the control group (1 cluster). Ethnicity was 78% Western European. The mean age (±SD) was 8.04±0.6 years (47.7% females) at baseline. Inclusion criteria for clusters were towns from the southern part of Catalonia having a minimum of 500 children aged 7–8 year; complete data for participants, including name, gender, date and place of birth, and written informed consent from parents or guardians. Intervention: The intervention focused on eight lifestyle topics covered in 12 activities (1 h/activity/session) implemented by health promoting agents in the primary school over three academic years. Primary and secondary outcomes: The primary outcome was obesity (OB) prevalence and the secondary outcomes were body mass index (BMI) collected every year and dietary habits and lifestyles collected by questionnaires filled in by parents at baseline and end-of-study. Results: At 22 months, the OB prevalence and BMI values were similar in intervention and control groups. Relative to children in control schools, the percentage of boys in the intervention group who performed ≥4 after-school PA h/week was 15% higher (p=0.027), whereas the percentage of girls in both groups remained similar. Also, 16.6% more boys in the intervention group watched ≤2 television (TV) h/day (p=0.009), compared to controls; and no changes were observed in girls in both groups. Conclusions: Our school-based intervention is feasible and reproducible by increasing after-school PA (to ≥4 h/week) in boys. Despite this improvement, there was no change in BMI and prevalence of OB.研究目的：评估在西班牙泰尔雷斯德埃布雷（Terres de l'Ebre）开展的、为期22个月的膳食教育（EdAl-2，Educació en Alimentació）教育干预项目的可重复性，该项目旨在改善包括膳食与身体活动（Physical Activity，PA）在内的生活方式。 研究设计：整群随机对照试验复刻研究。 研究场景：将两个半乡村城镇群的小学整群随机分配至干预组与对照组。 研究对象：共计690名小学生，其中干预组（1个整群）320人，对照组（1个整群）370人。受试者种族构成中78%为西欧裔；基线时平均年龄为8.04±0.6岁，女性占比47.7%。整群纳入标准为：加泰罗尼亚南部城镇，至少拥有500名7~8岁儿童；受试者需提供完整资料，包括姓名、性别、出生日期与出生地，且获得家长或监护人的书面知情同意。 干预措施：该干预围绕8项生活方式主题开展，共设置12次教学活动（每次时长1小时），由校内健康促进专员负责实施，周期跨越三个学年。 主要与次要结局指标：主要结局指标为肥胖（Obesity，OB）患病率；次要结局指标为每年收集的身体质量指数（Body Mass Index，BMI），以及由家长在基线与研究终点填写问卷获取的膳食习惯与生活方式情况。 研究结果：随访22个月时，干预组与对照组的肥胖患病率及BMI值无显著差异。相较于对照组儿童，干预组男孩每周课后身体活动时长≥4小时的占比高出15%（p=0.027），而两组女孩的该占比无明显差异。此外，干预组男孩每日看电视时长≤2小时的占比相较对照组高出16.6%（p=0.009），两组女孩未观察到此类变化。 研究结论：本校内干预项目具备可行性与可重复性，可提升男孩的课后身体活动水平至每周≥4小时。尽管该改善存在，但未对BMI及肥胖患病率产生显著影响。