Kovalskys Irina, Rausch Herscovici Cecile, Indart Rougier Paula, De Gregorio María José, Zonis Luciana, Orellana Liliana
International Life Sciences Institute (ILSI), Autonomous City of Buenos Aires, Argentina.
Favaloro University, Autonomous City of Buenos Aires, Argentina.
BMC Public Health. 2017 May 6;17(1):401. doi: 10.1186/s12889-017-4327-3.
MINI SALTEN is a program developed to increase moderate to vigorous physical activity (PA) and improve eating habits at home and school in first grade children. It aims to assess the effects of a technology family-based and PA school-based intervention. The purpose of this manuscript is to describe the protocol design and the MINISALTEN intervention.
This is cluster-randomized controlled trial designed to run from July 2015 to November 2016 in 12 public schools of the city of Buenos Aires, matched for socio-demographic characteristics. The intervention is based on two main components: (a) "active breaks" (AB): implemented during school breaks by a PA instructor; (b) "virtual" (V): web-based contents delivered to the families via a multiplatform application. Using a computer generated random sequence participants are allocated to one of four intervention conditions: (AB), (V), (AB + V), and control (C). Outcomes are measured at baseline and 12 months post intervention, and will include data collected from the child and her/his mother/father or guardian. Primary outcome measures are: PA and sedentary behaviour (measured with accelerometers). Secondary outcome measures related are: percentage of kilocalories (kcal) from added sugars, and from total and saturated fats; grams of fruits and vegetables; and number of snacks and kcal coming from their added sugars and total and saturated fats. Family socio-economic level, home environment, and school environment will also be assessed. Statistical analysis is on an intention-to-treat principle. Baseline characteristics are described using summary measures and mixed models (with school as random effect). The effect of the two interventions will be estimated using a generalized mixed linear model with link and distribution selected according to the type of outcome. Included random effects are: child (or mother/father or guardian) accounting for repeated measures; school accounting for cluster induced by school. The most parsimonious model for each outcome will be reported. The False Discovery Rate criterion will be used to correct for multiple testing in non-planned analyses.
It is a pioneer assessment of the impact of a technology-based virtual intervention and a school-based PA program, designed to prevent obesity, and involving the parents at public schools of Buenos Aires.
Current Controlled Trials ISRCTN58093412 . Registered March 14th, 2016 (retrospectively registered).
MINI SALTEN是一项旨在增加一年级儿童在家和学校的中度至剧烈身体活动（PA）并改善饮食习惯的项目。其目的是评估基于技术家庭和基于学校体育活动的干预效果。本文的目的是描述方案设计和MINISALTEN干预措施。
这是一项整群随机对照试验，于2015年7月至2016年11月在布宜诺斯艾利斯市的12所公立学校进行，这些学校在社会人口学特征方面相互匹配。干预措施基于两个主要组成部分：（a）“主动休息”（AB）：由体育活动指导员在学校课间实施；（b）“虚拟”（V）：通过多平台应用程序向家庭提供基于网络的内容。使用计算机生成的随机序列，参与者被分配到四种干预条件之一：（AB）、（V）、（AB + V）和对照组（C）。在基线和干预后12个月测量结果，包括从儿童及其母亲/父亲或监护人收集的数据。主要结局指标是：身体活动和久坐行为（用加速度计测量）。相关的次要结局指标是：添加糖、总脂肪和饱和脂肪的千卡百分比；水果和蔬菜的克数；以及零食数量和来自添加糖、总脂肪和饱和脂肪的千卡数。还将评估家庭社会经济水平、家庭环境和学校环境。统计分析遵循意向性分析原则。使用汇总指标和混合模型（以学校为随机效应）描述基线特征。将使用广义混合线性模型估计两种干预措施的效果，根据结局类型选择链接和分布。纳入的随机效应包括：儿童（或母亲/父亲或监护人）以考虑重复测量；学校以考虑学校引起的聚类。将报告每个结局的最简约模型。错误发现率标准将用于在非计划分析中校正多重检验。
这是对基于技术的虚拟干预和基于学校的体育活动项目影响的开创性评估，旨在预防肥胖，并让布宜诺斯艾利斯公立学校的家长参与其中。
当前受控试验ISRCTN58093412。2016年3月14日注册（追溯注册）。
