- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02800616
The Healthy Elementary School of the Future (THESF)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Experimentální: 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.
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Child absolute change in BMI Z-score, based on weight and height.
Časové okno: 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.
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Four years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Child hip and waist circumferences
Časové okno: 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
Časové okno: Four years
|
Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg
|
Four years
|
Child disease status
Časové okno: 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.
Časové okno: Obtained once
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Data previously obtained by the regional Public Health Services.
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Obtained once
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Parental BMI
Časové okno: Four years
|
Self-report measure (online parental questionnaire).
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Four years
|
Parental practices regarding nutrition
Časové okno: Four years
|
Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)
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Four years
|
Parental practices regarding physical activity
Časové okno: Four Years
|
Self-report measure (online parental questionnaire).questionnaire
developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)
|
Four Years
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Labour participation of parents
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: Four years
|
Assessed using the Strength and Difficulties Questionnaire.
|
Four years
|
Child social, emotional, and academic self-efficacy.
Časové okno: 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
Časové okno: Four years
|
Assessed with OnderwijsMonitor Limburg programme
|
Four years
|
Child physical activity and sedentary behavior (Actigraph accelerometer)
Časové okno: 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.
Časové okno: Four years
|
Self-report measure
|
Four years
|
Child food intake
Časové okno: 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.
Časové okno: 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
Časové okno: Four years
|
Self-report measure
|
Four years
|
Parental wellbeing
Časové okno: Four years
|
measured by the Satisfaction With Life Survey (SWLS)
|
Four years
|
Parental health-related quality of life
Časové okno: Four years
|
Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)
|
Four years
|
Socioeconomic status
Časové okno: Four years
|
Self-report measure
|
Four years
|
School/ teacher practices regarding nutrition and physical activity
Časové okno: 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
Časové okno: Four years
|
Written questionnaire
|
Four years
|
Child academic achievements
Časové okno: 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).
Časové okno: Four years
|
School registration system
|
Four years
|
School absenteeism and repeating classes
Časové okno: Four years
|
School registration system
|
Four years
|
Process evaluation using a school satisfaction questionnaire
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Onno van Schayck, Prof. Dr., Professor at Maastricht University
Publikace a užitečné odkazy
Obecné publikace
- Hahnraths MTH, Willeboordse M, van Assema P, Winkens B, van Schayck CP. The Effects of the Healthy Primary School of the Future on Children's Fruit and Vegetable Preferences, Familiarity and Intake. Nutrients. 2021 Sep 17;13(9):3241. doi: 10.3390/nu13093241.
- Oosterhoff M, Jolani S, De Bruijn-Geraets D, van Giessen A, Bosma H, van Schayck OCP, Joore MA. BMI trajectories after primary school-based lifestyle intervention: Unravelling an uncertain future. A mixed methods study. Prev Med Rep. 2021 Jan 7;21:101314. doi: 10.1016/j.pmedr.2021.101314. eCollection 2021 Mar.
- Oosterhoff M, Over EAB, van Giessen A, Hoogenveen RT, Bosma H, van Schayck OCP, Joore MA. Lifetime cost-effectiveness and equity impacts of the Healthy Primary School of the Future initiative. BMC Public Health. 2020 Dec 9;20(1):1887. doi: 10.1186/s12889-020-09744-9.
- Oosterhoff M, van Schayck OCP, Bartelink NHM, Bosma H, Willeboordse M, Winkens B, Joore MA. The Short-Term Value of the "Healthy Primary School of the Future" Initiative: A Social Return on Investment Analysis. Front Public Health. 2020 Aug 21;8:401. doi: 10.3389/fpubh.2020.00401. eCollection 2020.
- Palacios Temprano J, Eichholtz P, Willeboordse M, Kok N. Indoor environmental quality and learning outcomes: protocol on large-scale sensor deployment in schools. BMJ Open. 2020 Mar 16;10(3):e031233. doi: 10.1136/bmjopen-2019-031233.
- Bartelink NHM, van Assema P, Kremers SPJ, Savelberg HHCM, Oosterhoff M, Willeboordse M, van Schayck OCP, Winkens B, Jansen MWJ. Can the Healthy Primary School of the Future offer perspective in the ongoing obesity epidemic in young children? A Dutch quasi-experimental study. BMJ Open. 2019 Oct 31;9(10):e030676. doi: 10.1136/bmjopen-2019-030676.
- Bartelink NHM, van Assema P, Jansen MWJ, Savelberg HHCM, Moore GF, Hawkins J, Kremers SPJ. Process evaluation of the healthy primary School of the Future: the key learning points. BMC Public Health. 2019 Jun 6;19(1):698. doi: 10.1186/s12889-019-6947-2.
- Boudewijns EA, Pepels JJS, van Kann D, Konings K, van Schayck CP, Willeboordse M. Non-response and external validity in a school-based quasi-experimental study 'The Healthy Primary School of the Future': A cross-sectional assessment. Prev Med Rep. 2019 Apr 17;14:100874. doi: 10.1016/j.pmedr.2019.100874. eCollection 2019 Jun.
- Oosterhoff M, Joore MA, Bartelink NHM, Winkens B, Schayck OCP, Bosma H. Longitudinal analysis of health disparities in childhood. Arch Dis Child. 2019 Aug;104(8):781-788. doi: 10.1136/archdischild-2018-316482. Epub 2019 Apr 4.
- Willeboordse M, Jansen MW, van den Heijkant SN, Simons A, Winkens B, de Groot RH, Bartelink N, Kremers SP, van Assema P, Savelberg HH, de Neubourg E, Borghans L, Schils T, Coppens KM, Dietvorst R, Ten Hoopen R, Coomans F, Klosse S, Conjaerts MH, Oosterhoff M, Joore MA, Ferreira I, Muris P, Bosma H, Toppenberg HL, van Schayck CP. The Healthy Primary School of the Future: study protocol of a quasi-experimental study. BMC Public Health. 2016 Jul 26;16:639. doi: 10.1186/s12889-016-3301-9. Erratum In: BMC Public Health. 2017 Apr 11;17 (1):314.
Termíny studijních záznamů
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První zveřejněno (Odhad)
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