NCT02800616

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

4.2 years

First QC Date

March 2, 2016

Last Update Submit

September 21, 2020

Conditions

OverweightPhysical ActivityMalnutritionChild DevelopmentLifestyle-related ConditionSocioeconomic Difficulty

Keywords

Academic AchievementAccelerometryChildrenPrimary school InterventionNutritionObesityPhysical ActivityPreventionSchool Health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Four years

Secondary Outcomes (29)

  • Child hip and waist circumferences

    Four years

  • Child handgrip strength

    Four years

  • Child disease status

    Four years

  • Child pre-school blood pressure, birth weight, and information on disease history.

    Obtained once

  • Parental BMI

    Four years

  • +24 more secondary outcomes

Study Arms (3)

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.

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.

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.

Interventions

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.

Full intervention group
The Physical Activity SchoolBEHAVIORAL

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.

Partial intervention group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children and their caregivers enrolled at one of the participating schools

You may not qualify if:

  • None. Participants who switch schools during the four-year study period will not be followed-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 34579117DERIVED

  • 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.

    PMID: 33537184DERIVED

  • 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.

    PMID: 33297992DERIVED

  • 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.

    PMID: 32974255DERIVED

  • 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.

    PMID: 32184302DERIVED

  • 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.

    PMID: 31676651DERIVED

  • 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.

    PMID: 31170941DERIVED

  • 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.

    PMID: 31061783DERIVED

  • 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.

    PMID: 30948361DERIVED

  • 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.

    PMID: 27456845DERIVED

Related Links

MeSH Terms

Conditions

OverweightMotor ActivityMalnutritionMental DisordersObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Onno van Schayck, Prof. Dr.

    Professor at Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

June 15, 2016

Study Start

September 1, 2015

Primary Completion

November 1, 2019

Study Completion

July 1, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share