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The Healthy Elementary School of the Future (THESF)

2020年9月21日 更新者:Maastricht University
Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles often persist from generation to generation and contribute to a vicious cycle of health-related and social problems. We present a study protocol that examines the effectiveness of two novel, integrated healthy school interventions. One is a full intervention called 'The Healthy Primary School of the Future', the other is a partial intervention called 'The Physical Activity School'. These intervention approaches will be compared with the regular school approach that is currently common practice in the Netherlands. The main outcome measure will be changes in children's body mass index (BMI). In addition, lifestyle behaviours, academic achievement, child well-being, socio-economic differences, and societal costs will be examined.

研究概览

详细说明

In close collaboration with various stakeholders, a quasi-experimental study was developed, for which children of four intervention schools (n = 1200) in the southern part of the Netherlands are compared with children of four control schools (n = 1200) in the same region. The interventions started in November 2015. In two of the four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum. In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided.

We hypothesize that these healthy school interventions will result in normalized BMI distributions that are more in line with national and international standards (smaller standard deviations) among primary school children, with a more pronounced effect in the full intervention schools (due to the expected synergy between exercise and diet) than in the partial intervention schools. Also, our multi-disciplinary research group will study a wide range of outcome measures, including lifestyle behaviours, academic achievement, child well-being, socio-economic differences, and societal costs. Moreover, an evaluation will be performed of the legal consequences of a healthy school approach in the Netherlands, as well as the conflicting interests of the stakeholders. Data collection is conducted within the school system. The interventions proceed during a period of four years. The baseline measurements started in September 2015 and yearly follow-up measurements are taking place until 2019.

Our primary research question is: What is the effect of the full intervention ('The Healthy Primary School of the Future') on the BMI of primary school children compared to no intervention (control schools)? Our secondary research question is: What is the effect of the full intervention on the BMI of primary school children compared to the partial intervention ('The Physical Activity School')? Our tertiary research questions are: (1) What is the effect of the full intervention in comparison with the partial intervention and the regular school approach (control schools) on: (a) children's levels of physical activity and sedentary behaviour, nutritional knowledge, healthy food preferences and behaviour, cognitive and non-cognitive performance, Health related-QoL, socio-emotional development, and sick leave? (b) parenting and teacher practices regarding physical activity and nutrition? (c) parental HR-QoL, well-being, labour participation and sick leave? (d) benefits across different socio-economic backgrounds? (e) long and short term cost-effectiveness? (f) satisfaction among the involved stakeholders (children, parents, teachers, and child care partners)? (2) Which determinants influence the quality of the implementation of the intervention? (3) What is the scope of children's human rights to health, what is the legal role of primary schools in realizing these rights (e.g., obligations and responsibilities of state and non-state actors, conflicts of interests and legal solutions to these conflicts), and is the intervention feasible within Dutch educational law?

A whole-school approach is a new concept in the Netherlands. Due to its innovative, multifaceted nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society.

研究类型

介入性

注册 (实际的)

2349

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年 至 12年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All children and their caregivers enrolled at one of the participating schools

Exclusion Criteria:

  • None. Participants who switch schools during the four-year study period will not be followed-up.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:非随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Full intervention group
The full intervention ('The Healthy Primary School of the Future') is implemented in two schools involving extended school hours in which healthy nutrition, physical exercise, environmental, social, and educational activities are incorporated, during a period of four years.
In two out of four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum.
实验性的:Partial intervention group
The partial intervention ('The Physical Activity School') is implemented in two other schools: involving extended school hours in which healthy nutrition, physical exercise, environmental, social, and educational activities are incorporated, during a period of four years. Hence, this intervention only differs from the full intervention on the absence of nutritional intervention. Instead, children bring their own food from home, as they normally do.
In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided.
无干预:Control group
Four primary schools will function as control schools. The control schools have a representative Dutch school environment in terms of lifestyle education, school hours and amount of Physical Education (PE) lessons.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Child absolute change in BMI Z-score, based on weight and height.
大体时间:Four years
Weight is measured using a weighing scale, to the nearest 0.1 kg; height is measured using a measuring rod, to the nearest 0.1 cm.
Four years

次要结果测量

结果测量
措施说明
大体时间
Child hip and waist circumferences
大体时间:Four years
Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol
Four years
Child handgrip strength
大体时间:Four years
Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg
Four years
Child disease status
大体时间:Four years
Self-report measure (online parental questionnaire) since birth, hospital admissions (number and duration), healthcare visits (number), and medication use in the previous twelve months
Four years
Child pre-school blood pressure, birth weight, and information on disease history.
大体时间:Obtained once
Data previously obtained by the regional Public Health Services.
Obtained once
Parental BMI
大体时间:Four years
Self-report measure (online parental questionnaire).
Four years
Parental practices regarding nutrition
大体时间:Four years
Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)
Four years
Parental practices regarding physical activity
大体时间:Four Years
Self-report measure (online parental questionnaire).questionnaire developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)
Four Years
Labour participation of parents
大体时间:Four years
Current employment status (self reported) is combined with parental education level and household income to determine socio economic status (SES).
Four years
Parents' ethnicity and level of (material) deprivation
大体时间:Four years
Self-report measure (online parental questionnaire).
Four years
Parental sick leave and absence from work or education because of illness of their child.
大体时间:Four years
Self-report measure (online parental questionnaire). Labour participation is combined with parental sick leave rates to determine productivity losses from work.
Four years
Child health-related quality of life
大体时间:Four years
Examined with the validated EuroQol 5-Dimensions Youth version questionnaire (EQ-5D-Y) and the proxy version for parents. Child-specific HR-QoL is measured by the validated Paediatric Quality of Life Inventory (PedsQL) and parents complete the proxy version of this questionnaire.
Four years
Child psychological attributes
大体时间:Four years
Assessed using the Strength and Difficulties Questionnaire.
Four years
Child social, emotional, and academic self-efficacy.
大体时间:Four years
Tested using the Self-Efficacy Questionnaire for Children (SEQ-C).
Four years
Child self-confidence, social skills, self-efficacy, school well-being, and social support
大体时间:Four years
Assessed with OnderwijsMonitor Limburg programme
Four years
Child physical activity and sedentary behavior (Actigraph accelerometer)
大体时间:Four years
In the week in which the child is wearing the accelerometer, parents fill in a short activity diary on their child's physical activity and swimming behaviour and exceptional circumstances (e.g., illness of the child)
Four years
Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.
大体时间:Four years
Self-report measure
Four years
Child food intake
大体时间:Four years
Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents.
Four years
Child food preferences and familiarity with healthy food products.
大体时间:Four years
Self-report measure: The questions mainly consist of pictures of food items, for which children can indicate whether they have ever eaten these items and whether they like them or not.
Four years
Parental practices regarding nutrition and physical activity
大体时间:Four years
Self-report measure
Four years
Parental wellbeing
大体时间:Four years
measured by the Satisfaction With Life Survey (SWLS)
Four years
Parental health-related quality of life
大体时间:Four years
Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)
Four years
Socioeconomic status
大体时间:Four years
Self-report measure
Four years
School/ teacher practices regarding nutrition and physical activity
大体时间:Four years
E.g. modelling eating healthy food products and encouraging children's physical activity. Measured using adapted version of the Parental Practices Instrument
Four years
Teacher's self-reported height, weight and transport forms to work
大体时间:Four years
Written questionnaire
Four years
Child academic achievements
大体时间:Four years
Monitored using the Dutch national test called Centrale Eindtoets Basisonderwijs (CITO), and various other tests used by the schools. The CITO test measures language, maths and world orientation. In addition to the CITO test, many schools use a wide range of tests throughout the children's school careers. This also includes tests on maths (taken twice a year) and various aspects of language such as decoding skills, spelling, vocabulary, and reading comprehension.
Four years
School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).
大体时间:Four years
School registration system
Four years
School absenteeism and repeating classes
大体时间:Four years
School registration system
Four years
Process evaluation using a school satisfaction questionnaire
大体时间:Four years
Self-report measure: general parental satisfaction with their children's school (including safety, communication, quality of education, challenges to children, and professionalism of teachers). Implementation of the intervention is evaluated by qualitative outcome measures such as interviews with parents and children, and classroom observations.
Four years
Juridical evaluation through literature study and interviews
大体时间:Four years
Legal aspects will be addressed by a thorough scientific literature study and examination of policy and legislation instruments and case-law on the scope of children's right to health. Interviews with the parties involved in the healthy school setting will determine the juridical-related interests and possibilities.
Four years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Onno van Schayck, Prof. Dr.、Professor at Maastricht University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年9月1日

初级完成 (实际的)

2019年11月1日

研究完成 (实际的)

2020年7月1日

研究注册日期

首次提交

2016年3月2日

首先提交符合 QC 标准的

2016年6月9日

首次发布 (估计)

2016年6月15日

研究记录更新

最后更新发布 (实际的)

2020年9月22日

上次提交的符合 QC 标准的更新

2020年9月21日

最后验证

2020年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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