Increasing Children's Physical Activity by Policy (CAP): a Cluster Randomized Controlled Trial in the Stockholm Region Preschools
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Change in physical activity levels of children
研究概览
简要总结
Levels of physical activity (PA) and physical fitness in children are low and declining, both globally and in Sweden. Preschools are important settings with the potential to influence the majority (>93%) of Swedish children's PA behaviors in early stage of life (<5 years). Preschool policy is an organizational level factor associated with children's PA but the casual link remains unclear. A cluster randomized controlled trial will be conducted to explore the feasibility and effectiveness of implementing a policy package for children's PA levels and other relevant health indicators.
详细描述
The overarching aim of the proposed project is to examine the effects of implementing physical activity (PA) policies in preschools on PA and indicators of health in young children. The proposed project is a unique collaboration between the applicants and Stockholm stad which will result in PA policies, that will be implemented in all 658 public preschools within the Stockholm region, having the possibility to affect more than 38 000 children.
The current study is designed as a cluster randomized controlled trial with 2 conditions (intervention vs. control) and preschools serving as the unit of randomization. Measures of primary and secondary outcomes will be obtained at baseline and at 6-months on an individual level.
This study will provide robust evidence of the effect of structural changes, at the organizational level of preschools, on children's PA and indicators of health. Notably, such robust evidence is urgently warranted as Swedish preschool children's PA levels are low which will have long-lasting effects on their lives. Finally, as the intervention has been developed in co-creation with Stockholm stad it has the possibility to, if proven effective, be implemented rapidly within preschools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •On preschool level:
- •Located in Stockholm county
- •Public preschool
- •At least 60 children enrolled in preschool
- •Chief of the preschool accepted the invitation for participation
- •On individual level-preschool children
- •Enrolled in participating preschool
- •3-5 years old at the time of study start
- •Parents signed informed consent
- •Can participate in regular physical activity
- •On individual level-preschool teachers
- •Full-time employee at the participating preschool
- •Teachers responsible for participating children
排除标准
- •On preschool level:
- •Located outside Stockholm county
- •Private preschool
- •Less than 60 children enrolled in preschool
- •Chief of the preschool not willing to participate
- •On individual level-preschool children
- •Not enrolled in participating preschool
- •Outside 3-5 years old age range at study start
- •Parents declined informed consent
- •Cannot participate in regular physical activity due to mobility disability etc.
- •On individual level-preschool teachers
- •Not full-time employee at the participating preschool
- •Not responsible for any participating children
研究组 & 干预措施
Policy
The policy will be implemented on preschool level.
干预措施: Policy (Other)
Regular practice
The control preschool will continue their regular practice.
结局指标
主要结局
Change in physical activity levels of children
时间窗: Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)
Physical activity levels in terms of daily minutes in moderate to vigorous physical activity, total physical activity and daily steps measured objectively by Actigraph GT3X+ accelerometers
次要结局
- Change in sedentary time of children(Change from baseline to 6 months follow-up in daily minutes in sedentary time)
- Change in anthropometry (weight in kg) of children(Change from baseline to 6 months follow-up in anthropometry)
- Change in anthropometry (height in cm) of children(Change from baseline to 6 months follow-up in anthropometry)
- Change in compliance with the World Health Organization (WHO) guidelines on physical activity, sedentary behaviour and sleep for children under 5 years of age(Change from baseline to 6 months follow-up in compliance with The WHO guidelines.)
- Change in physical activity levels of teachers(Change from baseline to 6 months follow-up in physical activity levels)
- Change in musculoskeletal fitness of teachers(Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength))
- Change in psychosocial functioning of children(Change from baseline to 6 months follow-up in psychosocial functioning)
- Change in sleep of children(Change from baseline to 6 months follow-up in sleep)
- Sick leave frequency of children(From 12 months prior the intervention starts and during the 6 months intervention period)
- Change in anthropometry (waist circumference in cm) of teachers(Change from baseline to 6 months follow-up in anthropometry)
- Change in anthropometry (BMI) of teachers(Change from baseline to 6 months follow-up in anthropometry)
- Sick leave duration of teachers(From 12 months prior the intervention starts and during the 6 months intervention period)
- Change in anthropometry (BMI) of children(Change from baseline to 6 months follow-up in anthropometry)
- Sick leave duration of children(From 12 months prior the intervention starts and during the 6 months intervention period)
- Change in steps of teachers(Change from baseline to 6 months follow-up in steps)
- Change in sedentary time of teachers(Change from baseline to 6 months follow-up in daily minutes in sedentary time)
- Change in anthropometry (weight in kg) of teachers(Change from baseline to 6 months follow-up in anthropometry)
- Change in anthropometry (height in cm) of teachers(Change from baseline to 6 months follow-up in anthropometry)
- Change in musculoskeletal fitness of children(Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength))
- Change in anthropometry (waist circumference in cm) of children(Change from baseline to 6 months follow-up in anthropometry)
- Sick leave frequency of teachers(From 12 months prior the intervention starts and during the 6 months intervention period)
研究者
Daniel Berglind
Associate Professor
Karolinska Institutet