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Healthy Childcare Centre of the Future (HCCF)

3. října 2022 aktualizováno: Marla Hahnraths, Maastricht University

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.

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

315

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Panningen, Holandsko, 5981 CG
        • Stichting Prisma

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Child absolute change from baseline BMI z-score (based on weight and height) at two years
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Child dietary behaviour
Časové okno: 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).
Two years
Child physical activity behaviour (child-reported)
Časové okno: 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.
Two years
Child physical activity behaviour (parent-reported)
Časové okno: 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).
Two years
Child well-being at school
Časové okno: 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).
Two years
Child waist circumference
Časové okno: Two years
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
Časové okno: Two years
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
Časové okno: Two years
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
Časové okno: Two years
Assessed using the parental version of the Strength and Difficulties Questionnaire.
Two years
Child school absenteeism
Časové okno: Two years
School registration system.
Two years
Child sports club membership and active forms of transport to school
Časové okno: 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.
Two years
Factors influencing the implementation process (Process evaluation)
Časové okno: 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).
Two years
Factors influencing the implementation process and project satisfaction (Process evaluation)
Časové okno: 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.
Two years
Child health literacy
Časové okno: 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.
Two years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Marla Hahnraths, MSc, PhD Candidate

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. června 2020

Primární dokončení (Očekávaný)

1. srpna 2023

Dokončení studie (Očekávaný)

1. srpna 2023

Termíny zápisu do studia

První předloženo

3. prosince 2019

První předloženo, které splnilo kritéria kontroly kvality

9. prosince 2019

První zveřejněno (Aktuální)

10. prosince 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. října 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. října 2022

Naposledy ověřeno

1. října 2022

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • METCZ20190144

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

It is not our intention to share individual participant data with other researchers

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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