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Healthy Childcare Centre of the Future (HCCF)

2022년 10월 3일 업데이트: 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.

연구 개요

상태

모집하지 않고 적극적으로

상세 설명

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.

연구 유형

관찰

등록 (실제)

315

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Panningen, 네덜란드, 5981 CG
        • Stichting Prisma

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

Inclusion Criteria:

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

Exclusion Criteria:

  • None

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Child absolute change from baseline BMI z-score (based on weight and height) at two years
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Child dietary behaviour
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Two years
Assessed using the parental version of the Strength and Difficulties Questionnaire.
Two years
Child school absenteeism
기간: Two years
School registration system.
Two years
Child sports club membership and active forms of transport to school
기간: 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)
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Marla Hahnraths, MSc, PhD Candidate

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 6월 15일

기본 완료 (예상)

2023년 8월 1일

연구 완료 (예상)

2023년 8월 1일

연구 등록 날짜

최초 제출

2019년 12월 3일

QC 기준을 충족하는 최초 제출

2019년 12월 9일

처음 게시됨 (실제)

2019년 12월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 10월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 10월 3일

마지막으로 확인됨

2022년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • METCZ20190144

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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