OverweightTHESFNCT02800616
The Healthy Elementary School of the Future
A study testing The Healthy Primary School of the Future and The Physical Activity School in people with Overweight and Physical Activity, run by Maastricht University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Physical Activity, Malnutrition
- What is being tested?
- The Healthy Primary School of the Future and The Physical Activity School
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,349 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children and their caregivers enrolled at one of the participating schools
Who cannot join
- None. Participants who switch schools during the four-year study period will not be followed-up.
About this study
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.
Read the 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.
- Conditions
- Overweight, Physical Activity, Malnutrition, Child Development, Lifestyle-related Condition, Socioeconomic Difficulty
- Being tested
- The Healthy Primary School of the Future, The Physical Activity School
- Keywords
- Academic Achievement, Accelerometry, Children, Primary school Intervention, Nutrition, Obesity, Physical Activity, Prevention, School Health
- Medical subject headings
- Overweight, Motor Activity, Malnutrition, Mental Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Healthy Primary School of the FutureOther
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.
The Physical Activity SchoolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Full intervention group | Experimental | 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. Receives: Other: The Healthy Primary School of the Future |
| Partial intervention group | Experimental | 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. Receives: Behavioral: The Physical Activity School |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four years
Secondary outcomes (29)
Child hip and waist circumferences
Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol
Measured: Four years
Child handgrip strength
Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg
Measured: Four years
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
Measured: Four years
Child pre-school blood pressure, birth weight, and information on disease history.
Data previously obtained by the regional Public Health Services.
Measured: Obtained once
Parental BMI
Self-report measure (online parental questionnaire).
Measured: Four years
Parental practices regarding nutrition
Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)
Measured: Four years
Parental practices regarding physical activity
Self-report measure (online parental questionnaire).questionnaire developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)
Measured: Four Years
Labour participation of parents
Current employment status (self reported) is combined with parental education level and household income to determine socio economic status (SES).
Measured: Four years
Parents' ethnicity and level of (material) deprivation
Self-report measure (online parental questionnaire).
Measured: Four years
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.
Measured: Four years
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.
Measured: Four years
Child psychological attributes
Assessed using the Strength and Difficulties Questionnaire.
Measured: Four years
Child social, emotional, and academic self-efficacy.
Tested using the Self-Efficacy Questionnaire for Children (SEQ-C).
Measured: Four years
Child self-confidence, social skills, self-efficacy, school well-being, and social support
Assessed with OnderwijsMonitor Limburg programme
Measured: Four years
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)
Measured: Four years
Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.
Self-report measure
Measured: Four years
Child food intake
Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents.
Measured: Four years
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.
Measured: Four years
Parental practices regarding nutrition and physical activity
Self-report measure
Measured: Four years
Parental wellbeing
measured by the Satisfaction With Life Survey (SWLS)
Measured: Four years
Parental health-related quality of life
Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)
Measured: Four years
Socioeconomic status
Self-report measure
Measured: Four years
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
Measured: Four years
Teacher's self-reported height, weight and transport forms to work
Written questionnaire
Measured: Four years
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.
Measured: Four years
School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).
School registration system
Measured: Four years
School absenteeism and repeating classes
School registration system
Measured: Four years
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.
Measured: Four years
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.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionNov 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Onno van Schayck, Prof. Dr., Principal investigator, Professor at Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800616
- Sponsor's protocol ID
- UM MOVARE GGD
- Acronym
- THESF
- Status last verified
- Sep 2020
- First submitted
- 2 Mar 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34579117Oosterhoff 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.
PubMed 33537184Oosterhoff 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.
PubMed 33297992Oosterhoff 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.
PubMed 32974255Palacios 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.
PubMed 32184302Bartelink 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.
PubMed 31676651Bartelink 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.
PubMed 31170941Boudewijns 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.
PubMed 31061783Oosterhoff 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.
PubMed 30948361Willeboordse 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.
PubMed 27456845
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthy Elementary School of the Future
- ClinicalTrials.gov ID
- NCT02800616
- Acronym / sponsor ID
- THESF / UM MOVARE GGD
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,349 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full intervention group | Experimental | Other: The Healthy Primary School of the FutureThe 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. |
| Partial intervention group | Experimental | Behavioral: The Physical Activity SchoolThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children and their caregivers enrolled at one of the participating schools
Key exclusion criteria (1 listed)
- None. Participants who switch schools during the four-year study period will not be followed-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Healthy Primary School of the FutureIn 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. | Other | Full intervention group |
| The Physical Activity SchoolIn 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. | Behavioural | Partial intervention group |
Primary outcome
Child absolute change in BMI Z-score, based on weight and height.
Time frame: 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.
29 secondary outcomes
Child hip and waist circumferences
Time frame: Four years
Child handgrip strength
Time frame: Four years
Child disease status
Time frame: Four years
Child pre-school blood pressure, birth weight, and information on disease history.
Time frame: Obtained once
Parental BMI
Time frame: Four years
Parental practices regarding nutrition
Time frame: Four years
Parental practices regarding physical activity
Time frame: Four Years
Labour participation of parents
Time frame: Four years
Parents' ethnicity and level of (material) deprivation
Time frame: Four years
Parental sick leave and absence from work or education because of illness of their child.
Time frame: Four years
Child health-related quality of life
Time frame: Four years
Child psychological attributes
Time frame: Four years
Child social, emotional, and academic self-efficacy.
Time frame: Four years
Child self-confidence, social skills, self-efficacy, school well-being, and social support
Time frame: Four years
Child physical activity and sedentary behavior (Actigraph accelerometer)
Time frame: Four years
Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.
Time frame: Four years
Child food intake
Time frame: Four years
Child food preferences and familiarity with healthy food products.
Time frame: Four years
Parental practices regarding nutrition and physical activity
Time frame: Four years
Parental wellbeing
Time frame: Four years
Parental health-related quality of life
Time frame: Four years
Socioeconomic status
Time frame: Four years
School/ teacher practices regarding nutrition and physical activity
Time frame: Four years
Teacher's self-reported height, weight and transport forms to work
Time frame: Four years
Child academic achievements
Time frame: Four years
School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).
Time frame: Four years
School absenteeism and repeating classes
Time frame: Four years
Process evaluation using a school satisfaction questionnaire
Time frame: Four years
Juridical evaluation through literature study and interviews
Time frame: Four years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Derived from this study: PubMed 34579117Hahnraths 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.
- Derived from this study: PubMed 33537184Oosterhoff 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.
- Derived from this study: PubMed 33297992Oosterhoff 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.
- Derived from this study: PubMed 32974255Oosterhoff 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.
- Derived from this study: PubMed 32184302Palacios 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.
- Derived from this study: PubMed 31676651Bartelink 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.
- Derived from this study: PubMed 31170941Bartelink 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.
- Derived from this study: PubMed 31061783Boudewijns 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.
- Derived from this study: PubMed 30948361Oosterhoff 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.
- Derived from this study: PubMed 27456845Willeboordse 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.
- Official website about this project for various stakeholders (in Dutch)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onno van Schayck, Prof. Dr. principal investigator
Professor at Maastricht University
Questions about this trial
What is this clinical trial studying?
A study testing The Healthy Primary School of the Future and The Physical Activity School in people with Overweight and Physical Activity, run by Maastricht University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child absolute change in BMI Z-score, based on weight and height. (time frame: Four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800616, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.