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The Healthy Elementary School of the Future (THESF)

Primary Purpose

Overweight, Physical Activity, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Healthy Primary School of the Future
The Physical Activity School
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Academic Achievement, Accelerometry, Children, Primary school Intervention, Nutrition, Obesity, Physical Activity, Prevention, School Health

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Full intervention group

    Partial intervention group

    Control group

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Child hip and waist circumferences
    Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol
    Child handgrip strength
    Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg
    Child disease status
    Self-report measure (online parental questionnaire) since birth, hospital admissions (number and duration), healthcare visits (number), and medication use in the previous twelve months
    Child pre-school blood pressure, birth weight, and information on disease history.
    Data previously obtained by the regional Public Health Services.
    Parental BMI
    Self-report measure (online parental questionnaire).
    Parental practices regarding nutrition
    Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)
    Parental practices regarding physical activity
    Self-report measure (online parental questionnaire).questionnaire developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)
    Labour participation of parents
    Current employment status (self reported) is combined with parental education level and household income to determine socio economic status (SES).
    Parents' ethnicity and level of (material) deprivation
    Self-report measure (online parental questionnaire).
    Parental sick leave and absence from work or education because of illness of their child.
    Self-report measure (online parental questionnaire). Labour participation is combined with parental sick leave rates to determine productivity losses from work.
    Child health-related quality of life
    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.
    Child psychological attributes
    Assessed using the Strength and Difficulties Questionnaire.
    Child social, emotional, and academic self-efficacy.
    Tested using the Self-Efficacy Questionnaire for Children (SEQ-C).
    Child self-confidence, social skills, self-efficacy, school well-being, and social support
    Assessed with OnderwijsMonitor Limburg programme
    Child physical activity and sedentary behavior (Actigraph accelerometer)
    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)
    Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.
    Self-report measure
    Child food intake
    Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents.
    Child food preferences and familiarity with healthy food products.
    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.
    Parental practices regarding nutrition and physical activity
    Self-report measure
    Parental wellbeing
    measured by the Satisfaction With Life Survey (SWLS)
    Parental health-related quality of life
    Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)
    Socioeconomic status
    Self-report measure
    School/ teacher practices regarding nutrition and physical activity
    E.g. modelling eating healthy food products and encouraging children's physical activity. Measured using adapted version of the Parental Practices Instrument
    Teacher's self-reported height, weight and transport forms to work
    Written questionnaire
    Child academic achievements
    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.
    School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).
    School registration system
    School absenteeism and repeating classes
    School registration system
    Process evaluation using a school satisfaction questionnaire
    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.
    Juridical evaluation through literature study and interviews
    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.

    Full Information

    First Posted
    March 2, 2016
    Last Updated
    September 21, 2020
    Sponsor
    Maastricht University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02800616
    Brief Title
    The Healthy Elementary School of the Future
    Acronym
    THESF
    Official Title
    The Healthy Elementary School of the Future
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (Actual)
    Primary Completion Date
    November 2019 (Actual)
    Study Completion Date
    July 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maastricht University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2349 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Full intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Partial intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    The Healthy Primary School of the Future
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    The Physical Activity School
    Intervention Description
    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 Outcome Measure Information:
    Title
    Child absolute change in BMI Z-score, based on weight and height.
    Description
    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.
    Time Frame
    Four years
    Secondary Outcome Measure Information:
    Title
    Child hip and waist circumferences
    Description
    Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol
    Time Frame
    Four years
    Title
    Child handgrip strength
    Description
    Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg
    Time Frame
    Four years
    Title
    Child disease status
    Description
    Self-report measure (online parental questionnaire) since birth, hospital admissions (number and duration), healthcare visits (number), and medication use in the previous twelve months
    Time Frame
    Four years
    Title
    Child pre-school blood pressure, birth weight, and information on disease history.
    Description
    Data previously obtained by the regional Public Health Services.
    Time Frame
    Obtained once
    Title
    Parental BMI
    Description
    Self-report measure (online parental questionnaire).
    Time Frame
    Four years
    Title
    Parental practices regarding nutrition
    Description
    Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)
    Time Frame
    Four years
    Title
    Parental practices regarding physical activity
    Description
    Self-report measure (online parental questionnaire).questionnaire developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)
    Time Frame
    Four Years
    Title
    Labour participation of parents
    Description
    Current employment status (self reported) is combined with parental education level and household income to determine socio economic status (SES).
    Time Frame
    Four years
    Title
    Parents' ethnicity and level of (material) deprivation
    Description
    Self-report measure (online parental questionnaire).
    Time Frame
    Four years
    Title
    Parental sick leave and absence from work or education because of illness of their child.
    Description
    Self-report measure (online parental questionnaire). Labour participation is combined with parental sick leave rates to determine productivity losses from work.
    Time Frame
    Four years
    Title
    Child health-related quality of life
    Description
    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.
    Time Frame
    Four years
    Title
    Child psychological attributes
    Description
    Assessed using the Strength and Difficulties Questionnaire.
    Time Frame
    Four years
    Title
    Child social, emotional, and academic self-efficacy.
    Description
    Tested using the Self-Efficacy Questionnaire for Children (SEQ-C).
    Time Frame
    Four years
    Title
    Child self-confidence, social skills, self-efficacy, school well-being, and social support
    Description
    Assessed with OnderwijsMonitor Limburg programme
    Time Frame
    Four years
    Title
    Child physical activity and sedentary behavior (Actigraph accelerometer)
    Description
    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)
    Time Frame
    Four years
    Title
    Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.
    Description
    Self-report measure
    Time Frame
    Four years
    Title
    Child food intake
    Description
    Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents.
    Time Frame
    Four years
    Title
    Child food preferences and familiarity with healthy food products.
    Description
    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.
    Time Frame
    Four years
    Title
    Parental practices regarding nutrition and physical activity
    Description
    Self-report measure
    Time Frame
    Four years
    Title
    Parental wellbeing
    Description
    measured by the Satisfaction With Life Survey (SWLS)
    Time Frame
    Four years
    Title
    Parental health-related quality of life
    Description
    Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)
    Time Frame
    Four years
    Title
    Socioeconomic status
    Description
    Self-report measure
    Time Frame
    Four years
    Title
    School/ teacher practices regarding nutrition and physical activity
    Description
    E.g. modelling eating healthy food products and encouraging children's physical activity. Measured using adapted version of the Parental Practices Instrument
    Time Frame
    Four years
    Title
    Teacher's self-reported height, weight and transport forms to work
    Description
    Written questionnaire
    Time Frame
    Four years
    Title
    Child academic achievements
    Description
    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.
    Time Frame
    Four years
    Title
    School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).
    Description
    School registration system
    Time Frame
    Four years
    Title
    School absenteeism and repeating classes
    Description
    School registration system
    Time Frame
    Four years
    Title
    Process evaluation using a school satisfaction questionnaire
    Description
    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.
    Time Frame
    Four years
    Title
    Juridical evaluation through literature study and interviews
    Description
    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.
    Time Frame
    Four years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Onno van Schayck, Prof. Dr.
    Organizational Affiliation
    Professor at Maastricht University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34579117
    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.
    Results Reference
    derived
    PubMed Identifier
    33537184
    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.
    Results Reference
    derived
    PubMed Identifier
    33297992
    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.
    Results Reference
    derived
    PubMed Identifier
    32974255
    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.
    Results Reference
    derived
    PubMed Identifier
    32184302
    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.
    Results Reference
    derived
    PubMed Identifier
    31676651
    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.
    Results Reference
    derived
    PubMed Identifier
    31170941
    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.
    Results Reference
    derived
    PubMed Identifier
    31061783
    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.
    Results Reference
    derived
    PubMed Identifier
    30948361
    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.
    Results Reference
    derived
    PubMed Identifier
    27456845
    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. Erratum In: BMC Public Health. 2017 Apr 11;17 (1):314.
    Results Reference
    derived
    Links:
    URL
    http://www.degezondebasisschoolvandetoekomst.nl
    Description
    Official website about this project for various stakeholders (in Dutch)

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    The Healthy Elementary School of the Future

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