The Healthy Elementary School of the Future

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Healthy Elementary School of the Future

Conditions
-----------------
Overweight, Physical Activity, Malnutrition, Child Development, Lifestyle-related Condition, Socioeconomic Difficulty

Intervention / Treatment
-----------------
* Other: The Healthy Primary School of the Future
* Behavioral: The Physical Activity School


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full intervention group<br>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. | Other: The Healthy Primary School of the Future<br>* 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.<br>|
| Experimental: Partial intervention group<br>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. | Behavioral: The Physical Activity School<br>* 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.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child absolute change in BMI Z-score, based on weight and height. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child hip and waist circumferences | Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol | Four years | 
| Child handgrip strength | Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg | Four years | 
| Child disease status | 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. | Data previously obtained by the regional Public Health Services. | Obtained once | 
| Parental BMI | Self-report measure (online parental questionnaire). | Four years | 
| Parental practices regarding nutrition | 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 | 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 | 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 | Self-report measure (online parental questionnaire). | Four years | 
| Parental sick leave and absence from work or education because of illness of their child. | 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 | 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 | Assessed using the Strength and Difficulties Questionnaire. | Four years | 
| Child social, emotional, and academic self-efficacy. | 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 | Assessed with OnderwijsMonitor Limburg programme | Four years | 
| Child physical activity and sedentary behavior (Actigraph accelerometer) | 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. | Self-report measure | Four years | 
| Child food intake | 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. | 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 | Self-report measure | Four years | 
| Parental wellbeing | measured by the Satisfaction With Life Survey (SWLS) | Four years | 
| Parental health-related quality of life | Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D) | Four years | 
| Socioeconomic status | Self-report measure | Four years | 
| School/ teacher practices regarding nutrition and physical activity | 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 | Written questionnaire | Four years | 
| Child academic achievements | 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). | School registration system | Four years | 
| School absenteeism and repeating classes | School registration system | Four years | 
| Process evaluation using a school satisfaction questionnaire | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Academic Achievement, Accelerometry, Children, Primary school Intervention, Nutrition, Obesity, Physical Activity, Prevention, School Health