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Trial record 2 of 12 for:    healthy school maastricht

Healthy Childcare Centre of the Future (HCCF)

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ClinicalTrials.gov Identifier: NCT04193410
Recruitment Status : Active, not recruiting
First Posted : December 10, 2019
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Marla Hahnraths, Maastricht University

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.


Condition or disease Intervention/treatment
Health and Wellbeing of Primary School-aged Children Behavioral: Various health-promoting initiatives

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.

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Study Type : Observational
Actual Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Healthy Childcare Centre of the Future
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Child absolute change from baseline BMI z-score (based on weight and height) at two years [ Time Frame: 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.


Secondary Outcome Measures :
  1. Child dietary behaviour [ Time Frame: Two years ]
    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).

  2. 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.

  3. Child physical activity behaviour (parent-reported) [ Time Frame: Two years ]
    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).

  4. Child well-being at school [ Time Frame: Two years ]
    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).

  5. 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.

  6. Child hip circumference [ Time Frame: Two years ]
    Hip circumference is measured with a measuring tape to the nearest 0.1 cm, following the World Health Organisation's assessment protocol.

  7. Child health-related quality of life [ Time Frame: Two years ]
    Child-specific HR-QoL is measured by the validated parental proxy version of the Paediatric Quality of Life Inventory (PedsQL).

  8. Child psychological attributes [ Time Frame: Two years ]
    Assessed using the parental version of the Strength and Difficulties Questionnaire.

  9. Child school absenteeism [ Time Frame: Two years ]
    School registration system.

  10. Child sports club membership and active forms of transport to school [ Time Frame: Two years ]
    In a self-reported questionnaire, children indicate how they travelled to school that day and if they are member of any sport clubs.

  11. Factors influencing the implementation process (Process evaluation) [ Time Frame: Two years ]
    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).

  12. Factors influencing the implementation process and project satisfaction (Process evaluation) [ Time Frame: Two years ]
    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.

  13. Child health literacy [ Time Frame: Two years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193410


Locations
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Netherlands
Stichting Prisma
Panningen, Netherlands, 5981 CG
Sponsors and Collaborators
Maastricht University
Investigators
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Principal Investigator: Marla Hahnraths, MSc PhD candidate
  Study Documents (Full-Text)

Documents provided by Marla Hahnraths, Maastricht University:
Publications:

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Responsible Party: Marla Hahnraths, Principal Investigator, Maastricht University
ClinicalTrials.gov Identifier: NCT04193410    
Other Study ID Numbers: METCZ20190144
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not our intention to share individual participant data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marla Hahnraths, Maastricht University:
Nutrition
Physical activity
School
Children
Prevention
School Health