Health and Wellbeing of Primary School-aged Children Clinical Trial
— HCCFOfficial title:
Healthy Childcare Centre of the Future
| Verified date | October 2022 |
| Source | Maastricht University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Active, not recruiting |
| Enrollment | 315 |
| Est. completion date | August 2023 |
| Est. primary completion date | August 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Student from study years four to six (at baseline) at one of the the predetermined childcare centres Exclusion Criteria: - None |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Stichting Prisma | Panningen |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University |
Netherlands,
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). pii: E2243. doi: 10.3390/ijerph15102243. — View Citation
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. — View Citation
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). pii: E689. doi: 10.3390/nu11030689. — View Citation
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. Erratum in: BMC Public Health. 2017 Apr 11;17 (1):314. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Child psychological attributes | Assessed using the parental version of the Strength and Difficulties Questionnaire. | Two years | |
| Secondary | Child school absenteeism | School registration system. | Two years | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |