An observational study in Health and Wellbeing of Primary School-aged Children, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Maastricht University Medical Center · Observational
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.
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.
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This study's enrollment of 315 is above the median of 100 across 292 observational studies indexed under Motor Activity.
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A closed design will be used, meaning that at baseline (T0), all children in study year four to six of the childcare centres will be invited to participate in the study. At T1, these children will be students in study year five to seven, and at T2 they will be in study year six to eight. Based on the amount of children enrolled in school year 2019/2020, approximately 685 children are eligible to participate in the study.
Exclusion Criteria:
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.
BMI Z-score
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.
Time frame: Two years
Mean Number of Days Per Week of Healthy Dietary Behaviours
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.
Time frame: Two years
Child Physical Activity Behaviour (Child-reported)
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.
Time frame: Two years
Child Waist Circumference
Waist circumference is measured with a measuring tape to the nearest 0.1 cm, following the World Health Organisation's assessment protocol.
Time frame: Two years
Mean Number of Days Per Week of Soft Drink Consumption
Soft drink consumption during the past week was derived from the parental questionnaire ranging from never (0) to every day (7).
Time frame: Two years
Water Consumption During School Hours
Water consumption during school hours was derived from the child questionnaire ranging from never (0) to every day (3).
Time frame: Two years
Fruit Consumption at Lunch
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.
Time frame: Two years
Vegetable Consumption at Lunch
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.
Time frame: Two years
Grain Consumption at Lunch
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.
Time frame: Two years
Dairy Consumption at Lunch
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.
Time frame: Two years
Water Consumption at Lunch
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.
Time frame: Two years
Butter Consumption at Lunch
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.
Time frame: Two years
Consumption of at Least Two Healthy Food Groups During Lunch
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.
Time frame: Two years
| Milestone | Medium implementers | Low implementers |
|---|---|---|
| Started | 143 | 172 |
| Completed | 136 | 166 |
| Not completed | 7 | 6 |
| Withdrew: Lost to follow-up | 7 | 6 |
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.
| Z-score | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | -0.15 ± 0.82 | -0.10 ± 0.94 |
| T1 (after one year) | -0.14 ± 0.83 | -0.03 ± 0.97 |
| T2 (after two years) | -0.10 ± 0.88 | -0.05 ± 0.98 |
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.
| mean days/week | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 5.57 ± 0.96 | 5.56 ± 0.95 |
| T1 (after one year) | 5.38 ± 0.94 | 5.56 ± 0.90 |
| T2 (after two years) | 5.45 ± 0.90 | 5.52 ± 0.84 |
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.
| score on a scale | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 3.04 ± 0.64 | 2.94 ± 0.67 |
| T1 (after one year) | 3.19 ± 0.58 | 3.25 ± 0.59 |
| T2 (after two years) | 3.12 ± 0.62 | 3.17 ± 0.65 |
Waist circumference is measured with a measuring tape to the nearest 0.1 cm, following the World Health Organisation's assessment protocol.
| centimeters | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 56.84 ± 4.66 | 58.62 ± 6.77 |
| T1 (after one year) | 58.49 ± 5.64 | 59.40 ± 6.68 |
| T2 (after two years) | 61.12 ± 5.94 | 61.57 ± 7.11 |
Soft drink consumption during the past week was derived from the parental questionnaire ranging from never (0) to every day (7).
| mean days/week | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 4.31 ± 2.74 | 4.06 ± 2.78 |
| T1 (after one year) | 4.07 ± 2.67 | 3.63 ± 2.88 |
| T2 (after two years) | 3.35 ± 2.61 | 3.43 ± 2.70 |
Water consumption during school hours was derived from the child questionnaire ranging from never (0) to every day (3).
| mean days/week | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 1.43 ± 1.22 | 1.25 ± 1.13 |
| T1 (after one year) | 1.47 ± 1.13 | 1.40 ± 1.16 |
| T2 (after two years) | 1.63 ± 1.20 | 1.73 ± 1.17 |
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.
| percentage of yes | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 34.3 | 34.3 |
| T1 (after one year) | 31.4 | 26.8 |
| T2 (after two years) | 22.8 | 23.5 |
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.
| percentage of yes | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 24.5 | 25.6 |
| T1 (after one year) | 31.4 | 26.8 |
| T2 (after two years) | 19.9 | 19.9 |
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.
| percentage of yes | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 92.3 | 93.6 |
| T1 (after one year) | 94.2 | 93.5 |
| T2 (after two years) | 94.9 | 92.8 |
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.
| percentage of yes | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 37.1 | 33.7 |
| T1 (after one year) | 39.4 | 39.3 |
| T2 (after two years) | 48.5 | 38.0 |
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.
| percentage of yes | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 32.9 | 26.7 |
| T1 (after one year) | 38.0 | 31.0 |
| T2 (after two years) | 44.9 | 38.6 |
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.
| percentage of yes | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 59.4 | 62.2 |
| T1 (after one year) | 59.1 | 60.7 |
| T2 (after two years) | 55.1 | 56.6 |
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.
| percentage of yes | Medium implementers | Low implementers |
|---|---|---|
| T0 (baseline) | 87.4 | 88.4 |
| T1 (after one year) | 86.1 | 88.7 |
| T2 (after two years) | 89.7 | 86.7 |
Collected over One year after baseline and two years after baseline.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All participants | 0/315 (0%) | 0/315 (0%) | 0/315 (0%) |
| Age, Continuous(years) | Medium Implementers | Low Implementers | Total |
|---|---|---|---|
| Mean | 9.21 ± 1.00 | 9.17 ± 0.96 | 9.19 ± 0.98 |
| Sex: Female, Male(Participants) | Medium Implementers | Low Implementers | Total |
|---|---|---|---|
| Female | 72 | 105 | 177 |
| Male | 71 | 67 | 138 |
| Race/Ethnicity, Customized(Participants) | Medium Implementers | Low Implementers | Total |
|---|---|---|---|
| Western/Non-Western — Western | 125 | 149 | 274 |
| Western/Non-Western — Non-Western | 6 | 3 | 9 |
| Study year(Participants) | Medium Implementers | Low Implementers | Total |
|---|---|---|---|
| Four | 48 | 52 | 100 |
| Five | 37 | 62 | 99 |
| Six | 58 | 58 | 116 |
| Socioeconomic status(Participants) | Medium Implementers | Low Implementers | Total |
|---|---|---|---|
| Lowest tertile | 32 | 22 | 54 |
| Middle tertile | 39 | 47 | 86 |
| Highest tertile | 60 | 84 | 144 |
| BMI z-score(Z-score) | Medium Implementers | Low Implementers | Total |
|---|---|---|---|
| Mean | -0.15 ± 0.82 | -0.10 ± 0.94 | -0.13 ± 0.89 |
| Overweight/obese(Participants) | Medium Implementers | Low Implementers | Total |
|---|---|---|---|
| Overweight/obese | 43 | 21 | 64 |
| Normal weight | 100 | 151 | 251 |
| Waist circumference(centimeters) | Medium Implementers | Low Implementers | Total |
|---|---|---|---|
| Mean | 56.84 ± 4.66 | 58.62 ± 6.77 | 57.81 ± 5.96 |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — It is not our intention to share individual participant data with other researchers
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Maastricht University Medical Center