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The Healthy Elementary School of the Future (THESF)

21 de septiembre de 2020 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

2349

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

4 años a 12 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Experimental: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Child absolute change in BMI Z-score, based on weight and height.
Periodo de tiempo: 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

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Onno van Schayck, Prof. Dr., Professor at Maastricht University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2015

Finalización primaria (Actual)

1 de noviembre de 2019

Finalización del estudio (Actual)

1 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

2 de marzo de 2016

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2016

Publicado por primera vez (Estimar)

15 de junio de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2020

Última verificación

1 de septiembre de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UM MOVARE GGD

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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