An interventional study of The Healthy Primary School of the Future and The Physical Activity School in Overweight, Physical Activity and Malnutrition, sponsored by Maastricht University. Completed. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-22.
Sponsored by Maastricht University · Not applicable, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
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
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
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.
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.
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.
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.
Time frame: Four years
Child hip and waist circumferences
Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol
Time frame: Four years
Child handgrip strength
Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg
Time frame: 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
Time frame: Four years
Child pre-school blood pressure, birth weight, and information on disease history.
Data previously obtained by the regional Public Health Services.
Time frame: Obtained once
Parental BMI
Self-report measure (online parental questionnaire).
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Four years
Parents' ethnicity and level of (material) deprivation
Self-report measure (online parental questionnaire).
Time frame: 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.
Time frame: 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.
Time frame: Four years
Child psychological attributes
Assessed using the Strength and Difficulties Questionnaire.
Time frame: Four years
Child social, emotional, and academic self-efficacy.
Tested using the Self-Efficacy Questionnaire for Children (SEQ-C).
Time frame: Four years
Child self-confidence, social skills, self-efficacy, school well-being, and social support
Assessed with OnderwijsMonitor Limburg programme
Time frame: 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)
Time frame: 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
Time frame: Four years
Child food intake
Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents.
Time frame: 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.
Time frame: Four years
Parental practices regarding nutrition and physical activity
Self-report measure
Time frame: Four years
Parental wellbeing
measured by the Satisfaction With Life Survey (SWLS)
Time frame: Four years
Parental health-related quality of life
Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)
Time frame: Four years
Socioeconomic status
Self-report measure
Time frame: 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
Time frame: Four years
Teacher's self-reported height, weight and transport forms to work
Written questionnaire
Time frame: 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.
Time frame: Four years
School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).
School registration system
Time frame: Four years
School absenteeism and repeating classes
School registration system
Time frame: 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.
Time frame: 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.
Time frame: Four years
No study locations are listed for this record.
Plan to share: No
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Maastricht University