一项比较两种心血管健康教育策略在儿童人群中效果的整群随机临床试验：拯救心脏项目。

A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project.

机构信息

Agencia de Evaluación de Tecnología Sanitarias (AETS), ISCIII. Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa (IP).C/ Monforte de Lemos 5, Madrid 28029, Spain.

出版信息

BMC Public Health. 2012 Nov 23;12:1024. doi: 10.1186/1471-2458-12-1024.

DOI:10.1186/1471-2458-12-1024

PMID:23176593

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3524752/

Abstract

BACKGROUND

This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7-8 years.

METHODS/DESIGN: This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7-8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30) will be randomly assigned to one of two groups: 1) Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2) Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children) was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis.

DISCUSSION

The intervention providing the best results could be recommended as part of health education for young schoolchildren.

TRIAL REGISTRATION

Clinicaltrials.gov: NCT01418872.

摘要

背景

本文描述了一种将音乐音乐会和参与式课堂体验（涉及描述和制作健康早餐）进行比较的方法，作为向 7-8 岁儿童传递预防肥胖/心血管健康信息的教育手段。

方法/设计：本研究将采用集群随机试验和盲法评估。研究对象为马德里地区公立小学 7-8 岁的男女儿童。参与学校（n=30）将随机分为两组：1）MC 组，儿童将参加传递预防肥胖/心血管健康信息的音乐会；2）HB 组，儿童将参加参与式课堂，提供相同信息，但涉及描述和制作健康早餐。主要观察指标为知识问卷和态度测试的正确答案数量增加，该问卷和测试在干预前后进行。记录的次要结果是在干预前被认为超重/肥胖的儿童的 BMI 百分位数降低。根据比较比例的α为 0.05 和β为 0.20，计算了所需的样本量（儿童人数），假设 MC 组受试者在测量变量上的数值至少比 HB 组受试者高 10%。考虑到设计效果和 10%的随访损失进行了校正。所需的最大样本量为 2107 名儿童。使用每个群组的汇总测量值（包括估计和假设检验）对数据进行分析。所有分析均基于意向治疗。