Malden Stephen, Hughes Adrienne R, Gibson Ann-Marie, Bardid Farid, Androutsos Odysseas, De Craemer Marieke, Manios Yannis, Summerbell Carolyn, Cardon Greet, Reilly John J
Physical Activity for Health Group, School of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK.
School of Education, University of Strathclyde, Glasgow, UK.
BMJ Open. 2018 Oct 27;8(10):e023707. doi: 10.1136/bmjopen-2018-023707.
There is an increasing need for the adoption of effective preschool obesity prevention interventions to combat the high levels of early-childhood obesity in the UK. This study will examine the feasibility and acceptability of the adapted version of the ToyBox intervention-a preschool obesity prevention programme-for use in Scotland (ToyBox-Scotland). This will inform the design of a full-scale cluster randomised controlled trial (RCT).
The ToyBox-Scotland intervention will be evaluated using a feasibility cluster RCT, which involves children aged 3-5 years at six preschools in Glasgow, three randomly assigned to the intervention group and three to the usual-care control group. The original ToyBox intervention was adapted for the Scottish context using a coproduction approach. Within the 18-week intervention, physical activity and sedentary behaviour will be targeted in the preschool through environmental changes to the classroom, physical activity sessions and movement breaks. Parents will receive home activity packs every 3 weeks containing sticker incentives and interactive parent-child games that target sedentary behaviour, physical activity, eating/snacking and water consumption. As this is a feasibility study, parameters such as recruitment rates, attrition rates and SDs of outcome measures will be obtained which will inform a power calculation for a future RCT. Additional variables to be assessed include accelerometer-measured physical activity, sedentary behaviour and sleep, body mass index, home screen time, eating/snacking and water consumption. Outcomes will be assessed at baseline and 14-17 weeks later. Intervention fidelity will be assessed using questionnaires and interviews with parents and practitioners, observation and session delivery records.
This study was granted ethical approval by the University of Strathclyde's School of Psychological Sciences and Health Ethics Committee. Results will be disseminated through publication in peer-reviewed journals, presentation at conferences and in lay summaries provided to participants.
ISRCTN12831555.
英国幼儿肥胖水平居高不下，因此越来越需要采用有效的学前儿童肥胖预防干预措施。本研究将探讨经改编的ToyBox干预措施（一项学前儿童肥胖预防计划）在苏格兰使用（ToyBox-苏格兰版）的可行性和可接受性。这将为全面整群随机对照试验（RCT）的设计提供依据。
将采用可行性整群随机对照试验对ToyBox-苏格兰版干预措施进行评估，该试验涉及格拉斯哥六所学前班3至5岁的儿童，其中三所随机分配到干预组，三所分配到常规护理对照组。最初的ToyBox干预措施采用共同生产的方法进行了针对苏格兰情况的改编。在为期18周的干预期间，将通过对教室环境进行改变、开展体育活动课程和课间活动，来针对学前儿童的身体活动和久坐行为。家长每3周会收到家庭活动包，其中包含贴纸奖励以及针对久坐行为、身体活动、饮食/吃零食和饮水的亲子互动游戏。由于这是一项可行性研究，将获取诸如招募率、损耗率和结果测量标准差等参数，这些参数将为未来随机对照试验的样本量计算提供依据。其他待评估变量包括通过加速度计测量的身体活动、久坐行为和睡眠、体重指数、在家屏幕使用时间、饮食/吃零食和饮水情况。将在基线以及14至17周后评估结果。将通过对家长和从业者进行问卷调查和访谈、观察以及课程实施记录来评估干预的保真度。
本研究已获得斯特拉斯克莱德大学心理科学与健康伦理委员会的伦理批准。研究结果将通过在同行评审期刊上发表、在会议上展示以及向参与者提供的通俗总结进行传播。
ISRCTN12831555
