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The Healthy Elementary School of the Future (THESF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800616
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Maastricht University

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.

Condition or disease Intervention/treatment Phase
Overweight Physical Activity Malnutrition Child Development Lifestyle-related Condition Socioeconomic Difficulty Other: The Healthy Primary School of the Future Behavioral: The Physical Activity School Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2349 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Healthy Elementary School of the Future
Actual Study Start Date : September 2015
Actual Primary Completion Date : November 2019
Actual Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Full intervention group
The full intervention ('The Healthy Primary School of the Future') is implemented in two schools involving extended school hours in which healthy nutrition, physical exercise, environmental, social, and educational activities are incorporated, during a period of four years.
Other: The Healthy Primary School of the Future
In two out of four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum.

Experimental: Partial intervention group
The partial intervention ('The Physical Activity School') is implemented in two other schools: involving extended school hours in which healthy nutrition, physical exercise, environmental, social, and educational activities are incorporated, during a period of four years. Hence, this intervention only differs from the full intervention on the absence of nutritional intervention. Instead, children bring their own food from home, as they normally do.
Behavioral: The Physical Activity School
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.

No Intervention: 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Child hip and waist circumferences [ Time Frame: Four years ]
    Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol

  2. Child handgrip strength [ Time Frame: Four years ]
    Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg

  3. Child disease status [ Time Frame: 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

  4. Child pre-school blood pressure, birth weight, and information on disease history. [ Time Frame: Obtained once ]
    Data previously obtained by the regional Public Health Services.

  5. Parental BMI [ Time Frame: Four years ]
    Self-report measure (online parental questionnaire).

  6. Parental practices regarding nutrition [ Time Frame: Four years ]
    Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)

  7. Parental practices regarding physical activity [ Time Frame: Four Years ]
    Self-report measure (online parental questionnaire).questionnaire developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)

  8. Labour participation of parents [ Time Frame: Four years ]
    Current employment status (self reported) is combined with parental education level and household income to determine socio economic status (SES).

  9. Parents' ethnicity and level of (material) deprivation [ Time Frame: Four years ]
    Self-report measure (online parental questionnaire).

  10. Parental sick leave and absence from work or education because of illness of their child. [ Time Frame: Four years ]
    Self-report measure (online parental questionnaire). Labour participation is combined with parental sick leave rates to determine productivity losses from work.

  11. Child health-related quality of life [ Time Frame: 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.

  12. Child psychological attributes [ Time Frame: Four years ]
    Assessed using the Strength and Difficulties Questionnaire.

  13. Child social, emotional, and academic self-efficacy. [ Time Frame: Four years ]
    Tested using the Self-Efficacy Questionnaire for Children (SEQ-C).

  14. Child self-confidence, social skills, self-efficacy, school well-being, and social support [ Time Frame: Four years ]
    Assessed with OnderwijsMonitor Limburg programme

  15. Child physical activity and sedentary behavior (Actigraph accelerometer) [ Time Frame: 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)

  16. Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents. [ Time Frame: Four years ]
    Self-report measure

  17. Child food intake [ Time Frame: Four years ]
    Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents.

  18. Child food preferences and familiarity with healthy food products. [ Time Frame: 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.

  19. Parental practices regarding nutrition and physical activity [ Time Frame: Four years ]
    Self-report measure

  20. Parental wellbeing [ Time Frame: Four years ]
    measured by the Satisfaction With Life Survey (SWLS)

  21. Parental health-related quality of life [ Time Frame: Four years ]
    Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)

  22. Socioeconomic status [ Time Frame: Four years ]
    Self-report measure

  23. School/ teacher practices regarding nutrition and physical activity [ Time Frame: Four years ]
    E.g. modelling eating healthy food products and encouraging children's physical activity. Measured using adapted version of the Parental Practices Instrument

  24. Teacher's self-reported height, weight and transport forms to work [ Time Frame: Four years ]
    Written questionnaire

  25. Child academic achievements [ Time Frame: 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.

  26. School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered). [ Time Frame: Four years ]
    School registration system

  27. School absenteeism and repeating classes [ Time Frame: Four years ]
    School registration system

  28. Process evaluation using a school satisfaction questionnaire [ Time Frame: 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.

  29. Juridical evaluation through literature study and interviews [ Time Frame: 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.



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800616


Sponsors and Collaborators
Maastricht University
Investigators
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Principal Investigator: Onno van Schayck, Prof. Dr. Professor at Maastricht University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT02800616    
Other Study ID Numbers: UM MOVARE GGD
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maastricht University:
Academic Achievement
Accelerometry
Children
Primary school Intervention
Nutrition
Obesity
Physical Activity
Prevention
School Health
Additional relevant MeSH terms:
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Malnutrition
Overweight
Body Weight
Nutrition Disorders