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Completed

NCT Number: NCT02800616

The Healthy Elementary School of the Future

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Healthy Primary School of the Future

Other

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.

The Physical Activity School

Behavioral

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.

Primary outcomes

  1. Child absolute change in BMI Z-score, based on weight and height.

    Time frame: 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.

Secondary outcomes

  1. Child hip and waist circumferences

    Time frame: Four years

    Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol

  2. Child handgrip strength

    Time frame: Four years

    Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg

  3. Child disease status

    Time frame: 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

  4. Child pre-school blood pressure, birth weight, and information on disease history.

    Time frame: Obtained once

    Data previously obtained by the regional Public Health Services.

  5. Parental BMI

    Time frame: Four years

    Self-report measure (online parental questionnaire).

  6. Parental practices regarding nutrition

    Time frame: Four years

    Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)

  7. Parental practices regarding physical activity

    Time frame: Four Years

    Self-report measure (online parental questionnaire).questionnaire developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)

  8. Labour participation of parents

    Time frame: Four years

    Current employment status (self reported) is combined with parental education level and household income to determine socio economic status (SES).

  9. Parents' ethnicity and level of (material) deprivation

    Time frame: Four years

    Self-report measure (online parental questionnaire).

  10. Parental sick leave and absence from work or education because of illness of their child.

    Time frame: Four years

    Self-report measure (online parental questionnaire). Labour participation is combined with parental sick leave rates to determine productivity losses from work.

  11. Child health-related quality of life

    Time frame: 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.

  12. Child psychological attributes

    Time frame: Four years

    Assessed using the Strength and Difficulties Questionnaire.

  13. Child social, emotional, and academic self-efficacy.

    Time frame: Four years

    Tested using the Self-Efficacy Questionnaire for Children (SEQ-C).

  14. Child self-confidence, social skills, self-efficacy, school well-being, and social support

    Time frame: Four years

    Assessed with OnderwijsMonitor Limburg programme

  15. Child physical activity and sedentary behavior (Actigraph accelerometer)

    Time frame: 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)

  16. Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.

    Time frame: Four years

    Self-report measure

  17. Child food intake

    Time frame: Four years

    Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents.

  18. Child food preferences and familiarity with healthy food products.

    Time frame: 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.

  19. Parental practices regarding nutrition and physical activity

    Time frame: Four years

    Self-report measure

  20. Parental wellbeing

    Time frame: Four years

    measured by the Satisfaction With Life Survey (SWLS)

  21. Parental health-related quality of life

    Time frame: Four years

    Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)

  22. Socioeconomic status

    Time frame: Four years

    Self-report measure

  23. School/ teacher practices regarding nutrition and physical activity

    Time frame: Four years

    E.g. modelling eating healthy food products and encouraging children's physical activity. Measured using adapted version of the Parental Practices Instrument

  24. Teacher's self-reported height, weight and transport forms to work

    Time frame: Four years

    Written questionnaire

  25. Child academic achievements

    Time frame: 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.

  26. School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).

    Time frame: Four years

    School registration system

  27. School absenteeism and repeating classes

    Time frame: Four years

    School registration system

  28. Process evaluation using a school satisfaction questionnaire

    Time frame: 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.

  29. Juridical evaluation through literature study and interviews

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Acronym: THESF

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jun 15, 2016
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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