Healthy Childcare Centre of the Future

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Healthy Childcare Centre of the Future

Conditions
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Health and Wellbeing of Primary School-aged Children

Intervention / Treatment
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* Behavioral: Various health-promoting initiatives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Student from study years four to six (at baseline) at one of the the predetermined childcare centres Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Various health-promoting initiatives|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child absolute change from baseline BMI z-score (based on weight and height) at two years | Weight is measured to the nearest 0.1 kg (using a weighing scale) and height is measured to the nearest 0.1 cm (using a measuring rod). BMI is assessed by height and weight. Age- and gender-specific BMI cut-off points are used to define overweight and obesity. BMI z-scores are calculated using Dutch reference values. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child dietary behaviour | A food frequency questionnaire and a dietary recall tool (completed by both children and parents) are used to asses various aspects of children's dietary behaviour (e.g., lunch intake, snack intake, fruit and vegetable intake, water consumption). | 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. | Two years | 
| Child physical activity behaviour (parent-reported) | The children's total time spent on PA and sedentary behaviours is derived from the parent questionnaire. The number of days per PA behaviour (active transport, indoor and outdoor leisure time PA, and sport clubs) or sedentary behaviour (watching TV, computer use, social media use) are multiplied by the average number of minutes spent in a day and divided by seven (active transport was divided by five). The four specific PA behaviours are summed into a total time spend on PA behaviours (sum of min/day), and the three sedentary behaviours are summed into a total time spend on sedentary behaviours (sum of min/day). | Two years | 
| Child well-being at school | Assessed by seventeen statements based on the School Satisfaction subscale of the Multidimensional Students' Life Satisfaction Scale. Response options for the seventeen statements range from (1) 'completely false' to (6) 'completely true'. To obtain an overall score for school well-being, the scores for each statement are summed. Scores can range from 17 (low school well-being) to 102 (high school well-being). | 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. | Two years | 
| Child hip circumference | Hip circumference is measured with a measuring tape to the nearest 0.1 cm, following the World Health Organisation's assessment protocol. | Two years | 
| Child health-related quality of life | Child-specific HR-QoL is measured by the validated parental proxy version of the Paediatric Quality of Life Inventory (PedsQL). | Two years | 
| Child psychological attributes | Assessed using the parental version of the Strength and Difficulties Questionnaire. | Two years | 
| Child school absenteeism | School registration system. | Two years | 
| Child sports club membership and active forms of transport to school | In a self-reported questionnaire, children indicate how they travelled to school that day and if they are member of any sport clubs. | Two years | 
| Factors influencing the implementation process (Process evaluation) | Assessed in a questionnaire for teachers/pedagogical employees using fourteen statements based on the Measurement Instrument for Determinants of Innovations (MIDI). Statements assess organisational characteristics (n=6), innovation characteristics (n=2) and personal characteristics (n=6). Responses options for each statement range from 1 (totally disagree) to 5 (totally agree). By summing the scores for the individual statements within each category, three overall scores for organisational characteristics, innovation characteristics and personal characteristics are calculated. For organisational characteristics, the overall score ranges from 6 (barrier to implementation process) to 30 (facilitator for implementation process). For innovation characteristics, this range is 2 (barrier to implementation process) to 10 (facilitator for implementation process) and for personal characteristics this range is 6 (barrier to implementation process) to 30 (facilitator for implementation process). | Two years | 
| Factors influencing the implementation process and project satisfaction (Process evaluation) | Interviews with teachers, pedagogical employees and childcare centre directors are held to identify factors influencing the implementation process and to evaluate satisfaction with the project. | Two years | 
| Child health literacy | Health literacy is assessed by a Dutch translation of the HLS-Child-Q15. A secondary aim of this research project is to test and validate this translated questionnaire. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Physical activity, School, Children, Prevention, School Health