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Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial

2012年7月31日 更新者:Joachim E. Fischer、Heidelberg University
This study investigates whether a preschool-based physical activity intervention involving parents as active agents of behavioral change affects objectively measured physical activity in preschool children.

研究概览

详细说明

In the last 25 years, obesity in children has increased dramatically in Germany (Lampert et al. 2007, Stolzenberg et al., 2007) and other western societies. Lack of physical activity (PA) is one important factor contributing to obesity development. However, healthy behaviors are established early in life (adiposity rebound: Reilly 2008), which underlines the importance of early interventions. Preschools therefore might be an ideal setting for interventions to promote physical activity. While previous preschool interventions were directly aimed at the children's physical activity behaviors (e.g. promoting activity by sports lessons), parents as influential caregivers were mainly involved in educational ways and by information (e.g. newsletters, physical activity homework).

The current intervention takes a participatory approach to involve parents as active agents of behavioral change. The study aim is to evaluate the effects of the participatory preference-based parental intervention on preschoolers' objectively measured physical activity behaviour and Body Mass Index (BMI). The intervention can easily be added as a parent module to existing children-focused physical activity programmes.

In several workshops, parents are presented a set of possible project ideas for improving everyday physical activity in the preschools. After forming teams, they either select project ideas from the preexisting menu or develop ideas de novo and then implement them into the local preschool environment.

The intervention is implemented in the frame of an existing state-sponsored physical activity (PA) program offering twice weekly sports lessons by external gym trainers to preschoolers over a period of 6 months. Preschools in the control arm get the state-sponsored PA program only. Preschools in the intervention arm get the participatory parent-focused PA intervention in addition to the existing state-sponsored PA program.

研究类型

介入性

注册 (实际的)

826

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Baden-Württemberg
      • Mannheim、Baden-Württemberg、德国、68167
        • Mannheim Institute of Public Health, University of Heidelberg
      • Mannheim、Baden-Württemberg、德国、68167
        • Mannheim Institute of Public Health

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3年 至 6年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy children
  • Participation in the standard physical activity lesson twice weekly

Exclusion Criteria:

  • Age under 3 years or above 6 years
  • Serious atopic dermatitis
  • Genetic conditions
  • Metabolic diseases
  • Acute infectious diseases

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Existing state-sponsored PA program
standard children-focused gym lessons approach
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
其他名称:
  • Standard physical activity lessons
有源比较器:Participatory intervention plus state-sponsored PA program
Participatory parent-focused intervention over nine months in addition to state-sponsored PA program
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
其他名称:
  • Standard physical activity lessons
Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program
其他名称:
  • "Ene mene fit - Eltern machen mit!"

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in physical activity as measured by accelerometry and heart rate
大体时间:0,6 and 12 months
before intervention (0 months), 6 and 12 months later
0,6 and 12 months

次要结果测量

结果测量
措施说明
大体时间
Change in Body Mass Index, percent fat mass (based on skin folds), waist-to-height ratio and waist circumference Change in blood pressure, sympathetic/parasympathetic tone. Sleep quantity by accelerometry.
大体时间:0, 6 and 12 months
before intervention (0 months), 6 and 12 months later
0, 6 and 12 months

其他结果措施

结果测量
措施说明
大体时间
Change in quality of life and subjective wellbeing
大体时间:0, 6 and 12 months
before intervention (0 months), 6 and 12 months later
0, 6 and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Joachim E Fischer, Prof MD MSc、Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年9月1日

初级完成 (实际的)

2010年9月1日

研究完成 (实际的)

2011年4月1日

研究注册日期

首次提交

2010年2月16日

首先提交符合 QC 标准的

2010年2月16日

首次发布 (估计)

2010年2月17日

研究记录更新

最后更新发布 (估计)

2012年8月1日

上次提交的符合 QC 标准的更新

2012年7月31日

最后验证

2012年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • CRTLasti_PA_kiga

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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