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Clinical Trials/NCT04193410
NCT04193410CompletedNot Applicable

Healthy Childcare Centre of the Future

Maastricht University Medical Center1 site in 1 country315 target enrollmentStarted: June 15, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
315
Locations
1
Primary Endpoint
BMI Z-score

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Student from study years four to six (at baseline) at one of the the predetermined childcare centres

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Mean Number of Days Per Week of Healthy Dietary Behaviours(Two years)
  • Child Physical Activity Behaviour (Child-reported)(Two years)
  • Child Waist Circumference(Two years)
  • Mean Number of Days Per Week of Soft Drink Consumption(Two years)
  • Water Consumption During School Hours(Two years)
  • Fruit Consumption at Lunch(Two years)
  • Vegetable Consumption at Lunch(Two years)
  • Grain Consumption at Lunch(Two years)
  • Dairy Consumption at Lunch(Two years)
  • Water Consumption at Lunch(Two years)
  • Butter Consumption at Lunch(Two years)
  • Consumption of at Least Two Healthy Food Groups During Lunch(Two years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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