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The Healthy Elementary School of the Future (THESF)

21 settembre 2020 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2349

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 4 anni a 12 anni (Bambino)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Child absolute change in BMI Z-score, based on weight and height.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Child hip and waist circumferences
Lasso di tempo: 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
Lasso di tempo: Four years
Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg
Four years
Child disease status
Lasso di tempo: 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.
Lasso di tempo: Obtained once
Data previously obtained by the regional Public Health Services.
Obtained once
Parental BMI
Lasso di tempo: Four years
Self-report measure (online parental questionnaire).
Four years
Parental practices regarding nutrition
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Four years
Assessed using the Strength and Difficulties Questionnaire.
Four years
Child social, emotional, and academic self-efficacy.
Lasso di tempo: 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
Lasso di tempo: Four years
Assessed with OnderwijsMonitor Limburg programme
Four years
Child physical activity and sedentary behavior (Actigraph accelerometer)
Lasso di tempo: 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.
Lasso di tempo: Four years
Self-report measure
Four years
Child food intake
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: Four years
Self-report measure
Four years
Parental wellbeing
Lasso di tempo: Four years
measured by the Satisfaction With Life Survey (SWLS)
Four years
Parental health-related quality of life
Lasso di tempo: Four years
Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)
Four years
Socioeconomic status
Lasso di tempo: Four years
Self-report measure
Four years
School/ teacher practices regarding nutrition and physical activity
Lasso di tempo: 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
Lasso di tempo: Four years
Written questionnaire
Four years
Child academic achievements
Lasso di tempo: 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).
Lasso di tempo: Four years
School registration system
Four years
School absenteeism and repeating classes
Lasso di tempo: Four years
School registration system
Four years
Process evaluation using a school satisfaction questionnaire
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Onno van Schayck, Prof. Dr., Professor at Maastricht University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2015

Completamento primario (Effettivo)

1 novembre 2019

Completamento dello studio (Effettivo)

1 luglio 2020

Date di iscrizione allo studio

Primo inviato

2 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2016

Primo Inserito (Stima)

15 giugno 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2020

Ultimo verificato

1 settembre 2020

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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