A two-arm cluster-randomized feasibility trial at primary schools (n = 5 intervention schools [IS], n = 5 control schools) located in the Federal State of Bremen, Germany, was conducted. Children\'s habitual PA (GENEActiv, Activinsights Ltd.) and motor skills (Deutscher Motorik Test; DMT) were measured at the beginning (t0: Sept and Oct 2021) and at the end of the school year (t1: June and July 2022). Between Oct 2021 and July 2022, the ACTIPROS toolbox was implemented at IS. Teachers documented intervention choices and implementation within a short questionnaire (SIQ) at t1.
IS successfully implemented at least one intervention of the toolbox. In total, seven out of twelve possible interventions were selected. Two schools decided to replace an intervention with another during the trial. Results of the SIQ indicated that IS tended to choose similar interventions while implementation frequency was highly different. N = 429 students from two classes per school were recruited. The mean consent rate was 75.1% (n = 322). At t0 and t1, n = 304 (94.4%) and n = 256 (79.3%) of consented children took part in the DMT, respectively. The accelerometry sample included one class per participating school. At t0 and t1, n = 166 and n = 151 devices were handed out to students and n = 133 (80.1%) and n = 106 (70.2%) valid records could be retrieved, respectively. Linear mixed models showed an intervention effect of 15.5 min (95% CI: 4.5; 26.6) in children\'s daily MVPA at IS between t0 and t1 compared to controls.
All IS were able to implement at least one intervention from the toolbox, and unsuitable interventions were successfully replaced in a timely manner, highlighting the feasibility of implementing the ACTIPROS toolbox. Good consent rates for accelerometer and motor skills data were achieved. Results indicate a substantial increase in MVPA associated with the ACTIPROS toolbox and need to be tested in a larger sample.
German Clinical Trials Register DRKS00025840.
方法:在小学进行的双臂整群随机可行性试验(n=5所干预学校[IS],n=5控制学校)位于不来梅联邦州,德国,进行了。儿童习惯性PA(GENEActiv,ActivinsightsLtd.)和运动技能(DeutscherMotorikTest;DMT)在开始(t0:2021年9月和10月)和学年结束时(t1:2022年6月和7月)进行了测量。在2021年10月至2022年7月之间,ACTIPRAS工具箱在IS实施。教师在t1时在简短问卷(SIQ)中记录了干预选择和实施情况。
结果:IS成功实施了工具箱的至少一个干预措施。总的来说,选择了12种可能的干预措施中的7种.两所学校决定在审判期间用另一所学校代替干预措施。SIQ的结果表明,IS倾向于选择类似的干预措施,而实施频率则有很大差异。每个学校招募了来自两个班级的N=429名学生。平均同意率为75.1%(n=322)。在t0和t1,n=304(94.4%)和n=256(79.3%)的同意儿童参加了DMT,分别。加速度测量样本包括每个参与学校的一个班级。在t0和t1时,将n=166和n=151设备分发给学生,可以检索到n=133(80.1%)和n=106(70.2%)的有效记录,分别。线性混合模型显示,与对照组相比,在t0和t1之间的IS儿童每日MVPA的干预效果为15.5分钟(95%CI:4.5;26.6)。
结论:所有IS都能够从工具箱中实施至少一项干预措施,不合适的干预措施被及时成功取代,强调实施ACTIPRAS工具箱的可行性。实现了加速度计和运动技能数据的良好同意率。结果表明,与ACTIPRAS工具箱相关的MVPA大幅增加,需要在更大的样本中进行测试。
背景:德国临床试验注册DRKS00025840。