このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

The Healthy Elementary School of the Future (THESF)

2020年9月21日 更新者:Maastricht University
Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles often persist from generation to generation and contribute to a vicious cycle of health-related and social problems. We present a study protocol that examines the effectiveness of two novel, integrated healthy school interventions. One is a full intervention called 'The Healthy Primary School of the Future', the other is a partial intervention called 'The Physical Activity School'. These intervention approaches will be compared with the regular school approach that is currently common practice in the Netherlands. The main outcome measure will be changes in children's body mass index (BMI). In addition, lifestyle behaviours, academic achievement, child well-being, socio-economic differences, and societal costs will be examined.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

In close collaboration with various stakeholders, a quasi-experimental study was developed, for which children of four intervention schools (n = 1200) in the southern part of the Netherlands are compared with children of four control schools (n = 1200) in the same region. The interventions started in November 2015. In two of the four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum. In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided.

We hypothesize that these healthy school interventions will result in normalized BMI distributions that are more in line with national and international standards (smaller standard deviations) among primary school children, with a more pronounced effect in the full intervention schools (due to the expected synergy between exercise and diet) than in the partial intervention schools. Also, our multi-disciplinary research group will study a wide range of outcome measures, including lifestyle behaviours, academic achievement, child well-being, socio-economic differences, and societal costs. Moreover, an evaluation will be performed of the legal consequences of a healthy school approach in the Netherlands, as well as the conflicting interests of the stakeholders. Data collection is conducted within the school system. The interventions proceed during a period of four years. The baseline measurements started in September 2015 and yearly follow-up measurements are taking place until 2019.

Our primary research question is: What is the effect of the full intervention ('The Healthy Primary School of the Future') on the BMI of primary school children compared to no intervention (control schools)? Our secondary research question is: What is the effect of the full intervention on the BMI of primary school children compared to the partial intervention ('The Physical Activity School')? Our tertiary research questions are: (1) What is the effect of the full intervention in comparison with the partial intervention and the regular school approach (control schools) on: (a) children's levels of physical activity and sedentary behaviour, nutritional knowledge, healthy food preferences and behaviour, cognitive and non-cognitive performance, Health related-QoL, socio-emotional development, and sick leave? (b) parenting and teacher practices regarding physical activity and nutrition? (c) parental HR-QoL, well-being, labour participation and sick leave? (d) benefits across different socio-economic backgrounds? (e) long and short term cost-effectiveness? (f) satisfaction among the involved stakeholders (children, parents, teachers, and child care partners)? (2) Which determinants influence the quality of the implementation of the intervention? (3) What is the scope of children's human rights to health, what is the legal role of primary schools in realizing these rights (e.g., obligations and responsibilities of state and non-state actors, conflicts of interests and legal solutions to these conflicts), and is the intervention feasible within Dutch educational law?

A whole-school approach is a new concept in the Netherlands. Due to its innovative, multifaceted nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society.

研究の種類

介入

入学 (実際)

2349

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

4年~12年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • All children and their caregivers enrolled at one of the participating schools

Exclusion Criteria:

  • None. Participants who switch schools during the four-year study period will not be followed-up.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:非ランダム化
  • 介入モデル:階乗代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Full intervention group
The full intervention ('The Healthy Primary School of the Future') is implemented in two schools involving extended school hours in which healthy nutrition, physical exercise, environmental, social, and educational activities are incorporated, during a period of four years.
In two out of four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum.
実験的:Partial intervention group
The partial intervention ('The Physical Activity School') is implemented in two other schools: involving extended school hours in which healthy nutrition, physical exercise, environmental, social, and educational activities are incorporated, during a period of four years. Hence, this intervention only differs from the full intervention on the absence of nutritional intervention. Instead, children bring their own food from home, as they normally do.
In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided.
介入なし:Control group
Four primary schools will function as control schools. The control schools have a representative Dutch school environment in terms of lifestyle education, school hours and amount of Physical Education (PE) lessons.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Child absolute change in BMI Z-score, based on weight and height.
時間枠:Four years
Weight is measured using a weighing scale, to the nearest 0.1 kg; height is measured using a measuring rod, to the nearest 0.1 cm.
Four years

二次結果の測定

結果測定
メジャーの説明
時間枠
Child hip and waist circumferences
時間枠:Four years
Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol
Four years
Child handgrip strength
時間枠:Four years
Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg
Four years
Child disease status
時間枠:Four years
Self-report measure (online parental questionnaire) since birth, hospital admissions (number and duration), healthcare visits (number), and medication use in the previous twelve months
Four years
Child pre-school blood pressure, birth weight, and information on disease history.
時間枠:Obtained once
Data previously obtained by the regional Public Health Services.
Obtained once
Parental BMI
時間枠:Four years
Self-report measure (online parental questionnaire).
Four years
Parental practices regarding nutrition
時間枠:Four years
Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)
Four years
Parental practices regarding physical activity
時間枠:Four Years
Self-report measure (online parental questionnaire).questionnaire developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)
Four Years
Labour participation of parents
時間枠:Four years
Current employment status (self reported) is combined with parental education level and household income to determine socio economic status (SES).
Four years
Parents' ethnicity and level of (material) deprivation
時間枠:Four years
Self-report measure (online parental questionnaire).
Four years
Parental sick leave and absence from work or education because of illness of their child.
時間枠:Four years
Self-report measure (online parental questionnaire). Labour participation is combined with parental sick leave rates to determine productivity losses from work.
Four years
Child health-related quality of life
時間枠:Four years
Examined with the validated EuroQol 5-Dimensions Youth version questionnaire (EQ-5D-Y) and the proxy version for parents. Child-specific HR-QoL is measured by the validated Paediatric Quality of Life Inventory (PedsQL) and parents complete the proxy version of this questionnaire.
Four years
Child psychological attributes
時間枠:Four years
Assessed using the Strength and Difficulties Questionnaire.
Four years
Child social, emotional, and academic self-efficacy.
時間枠:Four years
Tested using the Self-Efficacy Questionnaire for Children (SEQ-C).
Four years
Child self-confidence, social skills, self-efficacy, school well-being, and social support
時間枠:Four years
Assessed with OnderwijsMonitor Limburg programme
Four years
Child physical activity and sedentary behavior (Actigraph accelerometer)
時間枠:Four years
In the week in which the child is wearing the accelerometer, parents fill in a short activity diary on their child's physical activity and swimming behaviour and exceptional circumstances (e.g., illness of the child)
Four years
Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.
時間枠:Four years
Self-report measure
Four years
Child food intake
時間枠:Four years
Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents.
Four years
Child food preferences and familiarity with healthy food products.
時間枠:Four years
Self-report measure: The questions mainly consist of pictures of food items, for which children can indicate whether they have ever eaten these items and whether they like them or not.
Four years
Parental practices regarding nutrition and physical activity
時間枠:Four years
Self-report measure
Four years
Parental wellbeing
時間枠:Four years
measured by the Satisfaction With Life Survey (SWLS)
Four years
Parental health-related quality of life
時間枠:Four years
Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)
Four years
Socioeconomic status
時間枠:Four years
Self-report measure
Four years
School/ teacher practices regarding nutrition and physical activity
時間枠:Four years
E.g. modelling eating healthy food products and encouraging children's physical activity. Measured using adapted version of the Parental Practices Instrument
Four years
Teacher's self-reported height, weight and transport forms to work
時間枠:Four years
Written questionnaire
Four years
Child academic achievements
時間枠:Four years
Monitored using the Dutch national test called Centrale Eindtoets Basisonderwijs (CITO), and various other tests used by the schools. The CITO test measures language, maths and world orientation. In addition to the CITO test, many schools use a wide range of tests throughout the children's school careers. This also includes tests on maths (taken twice a year) and various aspects of language such as decoding skills, spelling, vocabulary, and reading comprehension.
Four years
School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).
時間枠:Four years
School registration system
Four years
School absenteeism and repeating classes
時間枠:Four years
School registration system
Four years
Process evaluation using a school satisfaction questionnaire
時間枠:Four years
Self-report measure: general parental satisfaction with their children's school (including safety, communication, quality of education, challenges to children, and professionalism of teachers). Implementation of the intervention is evaluated by qualitative outcome measures such as interviews with parents and children, and classroom observations.
Four years
Juridical evaluation through literature study and interviews
時間枠:Four years
Legal aspects will be addressed by a thorough scientific literature study and examination of policy and legislation instruments and case-law on the scope of children's right to health. Interviews with the parties involved in the healthy school setting will determine the juridical-related interests and possibilities.
Four years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Onno van Schayck, Prof. Dr.、Professor at Maastricht University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年9月1日

一次修了 (実際)

2019年11月1日

研究の完了 (実際)

2020年7月1日

試験登録日

最初に提出

2016年3月2日

QC基準を満たした最初の提出物

2016年6月9日

最初の投稿 (見積もり)

2016年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2020年9月22日

QC基準を満たした最後の更新が送信されました

2020年9月21日

最終確認日

2020年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • UM MOVARE GGD

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。