- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04193410
Healthy Childcare Centre of the Future (HCCF)
Rationale: In 2015-2020, the Dutch 'Healthy Primary School of the Future' intervention took place. Two schools became 'Healthy Primary Schools of the Future'; providing a healthy lunch and structured physical activity (PA) sessions. Two other 'Physical Activity Schools' only implemented the PA sessions. The intervention showed promising effects on children's BMI z-score and dietary and PA behaviours. Following these promising results, childcare centres of educational board Prisma have expressed their interest in implementing changes fitting the 'Healthy Primary School of the Future'. However, this is more complex than it seems to be, as budget to implement changes is lower and all childcare centres have a unique context. Therefore, there is a need to investigate how 'Healthy Primary School of the Future' can successfully be implemented in various, real-life school-settings. It is hypothesised that to maximise implementation and sustainability, each childcare centre will need to put together a set of changes and interventions which fit the context and needs of all stakeholders involved. No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of stakeholders.
Objective: To study the implementation of 'Healthy Childcare Centre of the Future' in different school-contexts and develop guidelines that can be used to facilitate widespread dissemination of the initiative. Secondary objectives include evaluating the initiative's effects on children's BMI z-score, general health, dietary and PA behaviours and school well-being. To reach these objectives, a process evaluation, effect evaluation and cost-effectiveness evaluation will be executed. Data will be collected using questionnaires (parents, children, teachers, directors), anthropometric measures (children), interviews (teachers, directors), observations and analyses of minutes of meetings.
Study Overview
Status
Intervention / Treatment
Detailed Description
Rationale: From 2015-2020, the 'Healthy Primary School of the Future' intervention took place in Limburg, the Netherlands. The school environment of four primary schools changed. Two schools became 'Healthy Primary Schools of the Future'; providing their students with a healthy lunch and structured physical activity (PA) sessions during lunch time breaks. Two other 'Physical Activity Schools' only implemented the structured PA sessions. Interim analyses showed promising effects of the intervention; at two-year-follow-up, the study showed a significant decrease in BMI z-score of children in the 'Healthy Primary Schools of the Future' as compared with children in control schools. Also, positive intervention effects on dietary and PA behaviours were observed. Following these promising results, childcare centres of educational board Prisma have expressed their interest in implementing changes fitting the 'Healthy Primary School of the Future' initiative. However, this is more complex than it seems to be, as budget to implement changes is lower than in the original trial, and all childcare centres have a unique context. Therefore, there is a need to investigate how 'Healthy Primary School of the Future' can successfully be implemented in various, real-life school-settings. It is hypothesised that to maximise implementation and sustainability, each childcare centre will need to put together a set of changes and interventions which fit the context and needs of all stakeholders involved (e.g., the school board, teachers, parents and children).
Objective: The main objective is to study the implementation process of 'Healthy Childcare Centre of the Future' in different school-contexts and develop guidelines that can be used to facilitate widespread dissemination of the initiative. Secondary objectives include evaluating the effects of the 'Healthy Childcare Centre of the Future' on children's BMI z-score, general health, dietary and PA behaviours and school well-being. To reach these objectives, a process evaluation, effect evaluation and cost-effectiveness evaluation will be executed.
Study design: A non-randomised, non-controlled, observational study design. Study population: Children in study years four to six (at baseline) of twelve childcare centres located in Limburg, the Netherlands.
Main parameters/endpoints: The main study parameter of the effect evaluation is the change in absolute BMI z-score, which will be compared between the childcare centres categorised based on their degree of implementation (using categories based on the Diffusion of Innovations Theory).
Methods: Data will be collected in the form of questionnaires (parents, children, teachers/pedagogical employees, directors), anthropometric measurements (children), interviews (teachers/pedagogical employees, directors), observations and analyses of minutes of meetings.
Nature and extend of the burden and risks associated with participation: No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of childcare centre staff and parents. All outcome measures are non-invasive. The measurement protocol was designed while taking into account both a minimal burden for participants and a relevant scientific output for stakeholders (e.g., school board, teachers, parents/caregivers and children). Burden of participants is minimalised by incorporating most measurements in the regular school day.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Panningen, Netherlands, 5981 CG
- Stichting Prisma
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Student from study years four to six (at baseline) at one of the the predetermined childcare centres
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI Z-score
Time Frame: Two years
|
Children's Body Mass Index (BMI) was assessed by height and weight; age- and sex-specific BMI cut-off points were used to define overweight and obesity.
BMI z-scores were calculated using Dutch reference values.
A z-score of 0 represents the population mean.
A z-score > 0 means a BMI higher than the population mean, a z-score of < 0 means a BMI lower than the population mean, both can pose specific health-related risks.
|
Two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Number of Days Per Week of Healthy Dietary Behaviours
Time Frame: Two years
|
A composite score for healthy dietary behaviours was computed from four separate questions.
This score was calculated by averaging the weekly consumption (ranging from never (0) to every day (7)) of breakfast consumption and intake of fruit, warm and raw vegetables, and water throughout the day, as reported in the parental questionnaire.
|
Two years
|
|
Child Physical Activity Behaviour (Child-reported)
Time Frame: Two years
|
Assessed using the validated Physical Activity Questionnaire for Children (PAQ-C).The PAQ-C is a self-administered,7-day recall instrument, which provides a summary physical activity score derived from eight items, each scored on a 5-point scale.
Item 1 (spare time activity) from no activity = 1; 7 times or more = 5.
Items 2 to 7 (PE, lunch, right after school, evening, weekends) from lowest activity response = 1 or highest activity response = 5.
Item 8 (mean of all days of the week) from none = 1; very often = 5.
Item 9 (identifies students who are unusual active during the previous week).
By adding up all means of the first eight items in PAQ-C, a summative score of physical activity is obtained.
A score of 1 indicates low physical activity level, whereas a score of 5 indicates high physical activity level.
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Two years
|
|
Child Waist Circumference
Time Frame: Two years
|
Waist circumference is measured with a measuring tape to the nearest 0.1 cm, following the World Health Organisation's assessment protocol.
|
Two years
|
|
Mean Number of Days Per Week of Soft Drink Consumption
Time Frame: Two years
|
Soft drink consumption during the past week was derived from the parental questionnaire ranging from never (0) to every day (7).
|
Two years
|
|
Water Consumption During School Hours
Time Frame: Two years
|
Water consumption during school hours was derived from the child questionnaire ranging from never (0) to every day (3).
|
Two years
|
|
Fruit Consumption at Lunch
Time Frame: Two years
|
The child lunch questionnaire assessed children's consumption of certain food types during lunch.
The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
|
Two years
|
|
Vegetable Consumption at Lunch
Time Frame: Two years
|
The child lunch questionnaire assessed children's consumption of certain food types during lunch.
The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
|
Two years
|
|
Grain Consumption at Lunch
Time Frame: Two years
|
The child lunch questionnaire assessed children's consumption of certain food types during lunch.
The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
|
Two years
|
|
Dairy Consumption at Lunch
Time Frame: Two years
|
The child lunch questionnaire assessed children's consumption of certain food types during lunch.
The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
|
Two years
|
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Water Consumption at Lunch
Time Frame: Two years
|
The child lunch questionnaire assessed children's consumption of certain food types during lunch.
The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
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Two years
|
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Butter Consumption at Lunch
Time Frame: Two years
|
The child lunch questionnaire assessed children's consumption of certain food types during lunch.
The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
|
Two years
|
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Consumption of at Least Two Healthy Food Groups During Lunch
Time Frame: Two years
|
The child lunch questionnaire assessed children's consumption of certain food types during lunch.
The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.
To shed more light on the nutritional value of the children's lunches, the different food types consumed were summed, and a dichotomous variable was created indicating whether children consumed at least two of the food types during lunch.
|
Two years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marla Hahnraths, MSc, PhD candidate
Publications and helpful links
General Publications
- Bartelink NHM, Van Assema P, Jansen MWJ, Savelberg HHCM, Willeboordse M, Kremers SPJ. The Healthy Primary School of the Future: A Contextual Action-Oriented Research Approach. Int J Environ Res Public Health. 2018 Oct 12;15(10):2243. doi: 10.3390/ijerph15102243.
- 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.
- Bartelink NHM, van Assema P, Kremers SPJ, Savelberg HHCM, Oosterhoff M, Willeboordse M, van Schayck OCP, Winkens B, Jansen MWJ. One- and Two-Year Effects of the Healthy Primary School of the Future on Children's Dietary and Physical Activity Behaviours: A Quasi-Experimental Study. Nutrients. 2019 Mar 22;11(3):689. doi: 10.3390/nu11030689.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METCZ20190144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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