Clinical trial NCT02800616: The Healthy Elementary School of the Future
Official title: The Healthy Elementary School of the Future
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Physical Activity
Malnutrition
Child Development
Lifestyle-related Condition
Socioeconomic Difficulty
Keywords: Academic Achievement
Accelerometry
Children
Primary school Intervention
Nutrition
Obesity
Physical Activity
Prevention
School Health
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 2349
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Child absolute change in BMI Z-score, based on weight and height.
timeFrame: Four years
Secondary outcomes:
measure: Child hip and waist circumferences
timeFrame: Four years
measure: Child handgrip strength
timeFrame: Four years
measure: Child disease status
timeFrame: Four years
measure: Child pre-school blood pressure, birth weight, and information on disease history.
timeFrame: Obtained once
measure: Parental BMI
timeFrame: Four years
measure: Parental practices regarding nutrition
timeFrame: Four years
measure: Parental practices regarding physical activity
timeFrame: Four Years
measure: Labour participation of parents
timeFrame: Four years
measure: Parents' ethnicity and level of (material) deprivation
timeFrame: Four years
measure: Parental sick leave and absence from work or education because of illness of their child.
timeFrame: Four years
measure: Child health-related quality of life
timeFrame: Four years
measure: Child psychological attributes
timeFrame: Four years
measure: Child social, emotional, and academic self-efficacy.
timeFrame: Four years
measure: Child self-confidence, social skills, self-efficacy, school well-being, and social support
timeFrame: Four years
measure: Child physical activity and sedentary behavior (Actigraph accelerometer)
timeFrame: Four years
measure: Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.
timeFrame: Four years
measure: Child food intake
timeFrame: Four years
measure: Child food preferences and familiarity with healthy food products.
timeFrame: Four years
measure: Parental practices regarding nutrition and physical activity
timeFrame: Four years
measure: Parental wellbeing
timeFrame: Four years
measure: Parental health-related quality of life
timeFrame: Four years
measure: Socioeconomic status
timeFrame: Four years
measure: School/ teacher practices regarding nutrition and physical activity
timeFrame: Four years
measure: Teacher's self-reported height, weight and transport forms to work
timeFrame: Four years
measure: Child academic achievements
timeFrame: Four years
measure: School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).
timeFrame: Four years
measure: School absenteeism and repeating classes
timeFrame: Four years
measure: Process evaluation using a school satisfaction questionnaire
timeFrame: Four years
measure: Juridical evaluation through literature study and interviews
timeFrame: Four years
Other outcomes:
Locations:
Study officials:
affiliation: Professor at Maastricht University
name: Onno van Schayck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.