Increasing Children's Physical Activity by Policy (CAP)
2021年8月31日 更新者：Daniel Berglind、Karolinska Institutet
Increasing Children's Physical Activity by Policy (CAP): a Cluster Randomized Controlled Trial in the Stockholm Region Preschools
Levels of physical activity (PA) and physical fitness in children are low and declining, both globally and in Sweden.
Preschools are important settings with the potential to influence the majority (>93%) of Swedish children's PA behaviors in early stage of life (<5 years).
Preschool policy is an organizational level factor associated with children's PA but the casual link remains unclear.
A cluster randomized controlled trial will be conducted to explore the feasibility and effectiveness of implementing a policy package for children's PA levels and other relevant health indicators.
調査の概要
詳細な説明
The overarching aim of the proposed project is to examine the effects of implementing physical activity (PA) policies in preschools on PA and indicators of health in young children. The proposed project is a unique collaboration between the applicants and Stockholm stad which will result in PA policies, that will be implemented in all 658 public preschools within the Stockholm region, having the possibility to affect more than 38 000 children.
The current study is designed as a cluster randomized controlled trial with 2 conditions (intervention vs. control) and preschools serving as the unit of randomization. Measures of primary and secondary outcomes will be obtained at baseline and at 6-months on an individual level.
This study will provide robust evidence of the effect of structural changes, at the organizational level of preschools, on children's PA and indicators of health. Notably, such robust evidence is urgently warranted as Swedish preschool children's PA levels are low which will have long-lasting effects on their lives. Finally, as the intervention has been developed in co-creation with Stockholm stad it has the possibility to, if proven effective, be implemented rapidly within preschools.
研究の種類
介入
入学 (予想される)
4000
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Stockholm、スウェーデン、10431
- Karolinska Institutet
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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
3年～5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:
On preschool level:
- Located in Stockholm county
- Public preschool
- At least 60 children enrolled in preschool
- Chief of the preschool accepted the invitation for participation
On individual level-preschool children
- Enrolled in participating preschool
- 3-5 years old at the time of study start
- Parents signed informed consent
- Can participate in regular physical activity
On individual level-preschool teachers
- Full-time employee at the participating preschool
- Teachers responsible for participating children
Exclusion Criteria:
On preschool level:
- Located outside Stockholm county
- Private preschool
- Less than 60 children enrolled in preschool
- Chief of the preschool not willing to participate
On individual level-preschool children
- Not enrolled in participating preschool
- Outside 3-5 years old age range at study start
- Parents declined informed consent
- Cannot participate in regular physical activity due to mobility disability etc.
On individual level-preschool teachers
- Not full-time employee at the participating preschool
- Not responsible for any participating children
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Policy
The policy will be implemented on preschool level.
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The intervention will include: i. Formalized physical activity policies implemented in preschools including the following:
ii. A study website with an activity bank also serving as a platform for inter-professional education that preschool teachers can share and communicate about engaging activities and experience iii. Weekly follow-up and feedback by web-based questionnaires |
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介入なし：Regular practice
The control preschool will continue their regular practice.
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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 |
|---|---|---|
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Change in physical activity levels of children
時間枠：Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)
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Physical activity levels in terms of daily minutes in moderate to vigorous physical activity, total physical activity and daily steps measured objectively by Actigraph GT3X+ accelerometers
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Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in sedentary time of children
時間枠：Change from baseline to 6 months follow-up in daily minutes in sedentary time
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Daily sedentary time in minutes assessed by the Actigraph GT3X+
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Change from baseline to 6 months follow-up in daily minutes in sedentary time
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Change in musculoskeletal fitness of children
時間枠：Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
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Musculoskeletal fitness, in terms of handgrip strength ,will be measured by an analogue dynamometer (TKK 5825, Grip-A, Takei, Tokyo, Japan).
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Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
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Change in anthropometry (weight in kg) of children
時間枠：Change from baseline to 6 months follow-up in anthropometry
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Weight will be measured by validated scales (calibrated scale: VB2-200-EC, Vetek AB, Väddö, Sweden)
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Change from baseline to 6 months follow-up in anthropometry
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Change in anthropometry (height in cm) of children
時間枠：Change from baseline to 6 months follow-up in anthropometry
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Height will be measured by validated scales (portable stadiometer: Seca 213, Seca, Chino, CA, USA)
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Change from baseline to 6 months follow-up in anthropometry
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Change in anthropometry (waist circumference in cm) of children
時間枠：Change from baseline to 6 months follow-up in anthropometry
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Waist circumference will be measured at the level of the navel directly on the skin
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Change from baseline to 6 months follow-up in anthropometry
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Change in anthropometry (BMI) of children
時間枠：Change from baseline to 6 months follow-up in anthropometry
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Weight and height will be combined to report BMI in kg/m^2
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Change from baseline to 6 months follow-up in anthropometry
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Change in psychosocial functioning of children
時間枠：Change from baseline to 6 months follow-up in psychosocial functioning
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Psychosocial functioning of children will be assessed by a parental proxy report of the Strength and Difficulty Questionnaire.
Total difficulties score is generated by summing scores from all the scales except the prosocial scale and ranges from 0 to 40, higher score means worse outcome.
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Change from baseline to 6 months follow-up in psychosocial functioning
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Change in sleep of children
時間枠：Change from baseline to 6 months follow-up in sleep
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Sleep will be measured objectively by the GT3X+ accelerometer combined with a sleep time diary documented by parents during the days when the child is wearing the accelerometer.
In addition, parents will answer questions about children's sleep duration and quality in the last 6 months in the sleep questionnaire.
These sleep questions are adapted from the validated Ages and Stages Questionnaire.
The sleep quality score ranges from 0-12 and higher score means better outcome.
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Change from baseline to 6 months follow-up in sleep
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Sick leave duration of children
時間枠：From 12 months prior the intervention starts and during the 6 months intervention period
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Sick leave duration in terms of total days of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
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From 12 months prior the intervention starts and during the 6 months intervention period
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Sick leave frequency of children
時間枠：From 12 months prior the intervention starts and during the 6 months intervention period
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Sick leave frequency in terms of total occasions of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
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From 12 months prior the intervention starts and during the 6 months intervention period
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Change in compliance with the World Health Organization (WHO) guidelines on physical activity, sedentary behaviour and sleep for children under 5 years of age
時間枠：Change from baseline to 6 months follow-up in compliance with The WHO guidelines.
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World Health Organization (WHO) has published guidelines recommending more than 180 minutes of total physical activity with at least 60 minutes of moderate to vigorous physical activity, less than one hour of screen time and 10-13 hours of sleep across 24 hours
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Change from baseline to 6 months follow-up in compliance with The WHO guidelines.
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Change in physical activity levels of teachers
時間枠：Change from baseline to 6 months follow-up in physical activity levels
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Physical activity levels in terms of daily minutes in moderate to vigorous physical activity measured by Actigraph GT3X+
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Change from baseline to 6 months follow-up in physical activity levels
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Change in steps of teachers
時間枠：Change from baseline to 6 months follow-up in steps
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Steps measured by Actigraph GT3X+
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Change from baseline to 6 months follow-up in steps
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Change in sedentary time of teachers
時間枠：Change from baseline to 6 months follow-up in daily minutes in sedentary time
|
Daily sedentary time in minutes assessed by the Actigraph GT3X+
|
Change from baseline to 6 months follow-up in daily minutes in sedentary time
|
|
Change in musculoskeletal fitness of teachers
時間枠：Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
|
Musculoskeletal fitness, in terms of handgrip strength ,will be measured by an analogue dynamometer (TKK 5825, Grip-A, Takei, Tokyo, Japan).
|
Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
|
|
Change in anthropometry (weight in kg) of teachers
時間枠：Change from baseline to 6 months follow-up in anthropometry
|
Weight validated scales (calibrated scale: VB2-200-EC, Vetek AB, Väddö, Sweden)
|
Change from baseline to 6 months follow-up in anthropometry
|
|
Change in anthropometry (height in cm) of teachers
時間枠：Change from baseline to 6 months follow-up in anthropometry
|
Height will be measured by validated scales (portable stadiometer: Seca 213, Seca, Chino, CA, USA)
|
Change from baseline to 6 months follow-up in anthropometry
|
|
Change in anthropometry (waist circumference in cm) of teachers
時間枠：Change from baseline to 6 months follow-up in anthropometry
|
Waist circumference will be measured at the level of the navel directly on the skin
|
Change from baseline to 6 months follow-up in anthropometry
|
|
Change in anthropometry (BMI) of teachers
時間枠：Change from baseline to 6 months follow-up in anthropometry
|
Weight and height will be combined to report BMI in kg/m^2
|
Change from baseline to 6 months follow-up in anthropometry
|
|
Sick leave duration of teachers
時間枠：From 12 months prior the intervention starts and during the 6 months intervention period
|
Sick leave duration in terms of total days of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
|
From 12 months prior the intervention starts and during the 6 months intervention period
|
|
Sick leave frequency of teachers
時間枠：From 12 months prior the intervention starts and during the 6 months intervention period
|
Sick leave frequency in terms of total occasions of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
|
From 12 months prior the intervention starts and during the 6 months intervention period
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in preschool policy and environmental characteristics (process outcome)
時間枠：Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months
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Preschool environmental characteristic such as available paly equipment, playground characteristic, policy, working practices will be assessed by validated Environment and Policy Evaluation and Observation as a Self-Report Instrument (EPAO-SR).
The preschool playground characteristics and size will be double checked using google maps.
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Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months
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Implementation of the policy package (process outcome)
時間枠：Measured weekly throughout 6 months only in intervention preschools
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Fidelity and dose of the implementation of the policy package will be documented through weekly feedback questionnaires throughout the intervention.
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Measured weekly throughout 6 months only in intervention preschools
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Normalization of the policy package into preschool teachers' regular practice (process outcome)
時間枠：Measured at 6 months only in intervention preschools
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The extent to which the intervention can be normalized into preschool staff's regular practice will be assessed through No-MAD: Implementation measure based on Normalization Process Theory.
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Measured at 6 months only in intervention preschools
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Change in children's physical activity opportunities outside preschool time (process outcome)
時間枠：Change from baseline to 6 months follow-up in children's physical activity opportunities outside preschool time
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Children's PA opportunities in terms of active transport and participation in organized sports will be assessed via a questionnaire (daily during the period that children are wearing the accelerometers) where parents answer time, duration and type of organized sports and mode of transportation to and from preschool.
In addition, several parental practices (outdoor time during the weekend, parental perception of physical activity, parental physical activity, and active play with parents) which could potentially influence children daily physical activity levels will also be assessed by questionnaire.
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Change from baseline to 6 months follow-up in children's physical activity opportunities outside preschool time
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Project evaluation from parents
時間枠：Measured at 6 months (questionnaires and interviews)
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How parents perceive and evaluate the intervention measured through questionnaire and interview.
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Measured at 6 months (questionnaires and interviews)
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Project evaluation from preschool teachers
時間枠：Measured at 6 months ((questionnaires and interviews)
|
How preschool teachers perceive and evaluate the intervention measured through questionnaire and interview.
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Measured at 6 months ((questionnaires and interviews)
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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：Daniel Berglind, Associate Professor、Karolinska Institutet
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。
便利なリンク
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)
2020年9月23日
一次修了 (実際)
2021年7月2日
研究の完了 (予想される)
2021年12月31日
試験登録日
最初に提出
2020年9月16日
QC基準を満たした最初の提出物
2020年9月23日
最初の投稿 (実際)
2020年9月30日
学習記録の更新
投稿された最後の更新 (実際)
2021年9月1日
QC基準を満たした最後の更新が送信されました
2021年8月31日
最終確認日
2021年8月1日
詳しくは
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。
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