Li Bai, Liu Wei Jia, Adab Peymane, Pallan Miranda, Hemming Karla, Frew Emma, Lin Rong, Martin James, Liu Wei, Cheng Kar Keung
Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Faculty of School Health, Guangzhou Centre for Disease Control and Prevention, Guangzhou, PR China.
BMJ Open. 2017 Dec 1;7(11):e018415. doi: 10.1136/bmjopen-2017-018415.
Childhood obesity in China has increased more rapidly and over a shorter time period than in other countries. However, there is a paucity of rigorously developed and evaluated prevention interventions. We aim to evaluate the clinical and cost-effectiveness as well as the implementation process of a complex multicomponent intervention developed using the UK Medical Research Council (MRC) framework. This study provides one of the first examples of rigorous development and evaluation of a childhood obesity prevention programme in a non-western population using the MRC methods.
A cluster-randomised controlled trial in 40 primary schools in Guangzhou, China, including children aged 6-7 years at baseline. Schools will be randomly allocated to either the usual practice (n=20) or intervention arm (n=20). The 12-month intervention consists of four components targeting diet and physical activity behaviours in and outside school, with family involvement. The primary objective is to compare the difference in mean body mass index (BMI) z-score between the intervention and control arms at the end of the intervention (starting March/April 2017). A sample size of 1640 pupils recruited from 40 schools is sufficient to detect a difference of 0.17 units in the mean BMI z-score with a power of 80% (ICC=0.01. ICC, intraclass correlation coefficient) and a significance level of 5%. Treatment effects will be tested using a mixed linear model in STATA adjusting for the child baseline BMI z-score and clustering by school. All analyses will be by intention to treat. Secondary analyses will additionally adjust for prespecified school-level and child-level covariates. The incremental cost-effectiveness ratio for the intervention versus usual practice will be 'cost per quality-adjusted life year (QALY)'. Cost per change in BMI z-score will also be assessed. A range of methods will be used to evaluate intervention implementation, mechanisms of impact and contextual factors.
Ethical approval was obtained from the Life and Health Sciences Ethical Review Committee at the University of Birmingham and the Ethical Committee of Guangzhou Centre for Disease Control and Prevention. The primary, secondary, process evaluation and economic evaluation results of the trial will be disseminated through relevant international peer-reviewed journals and conferences.
ISRCTN11867516; Pre-results.
中国儿童肥胖问题在更短时间内的增长速度比其他国家更快。然而，经过严格开发和评估的预防干预措施却很匮乏。我们旨在评估一项使用英国医学研究委员会（MRC）框架开发的复杂多组分干预措施的临床效果、成本效益以及实施过程。本研究首次提供了一个在非西方人群中使用MRC方法对儿童肥胖预防项目进行严格开发和评估的实例。
在中国广州的40所小学开展一项整群随机对照试验，基线时纳入6至7岁的儿童。学校将被随机分配至常规做法组（n = 20）或干预组（n = 20）。为期12个月的干预措施包括针对校内和校外饮食及身体活动行为的四个组分，并涉及家庭参与。主要目标是比较干预结束时（2017年3月/4月开始）干预组和对照组之间平均体重指数（BMI）z评分的差异。从40所学校招募1640名学生的样本量足以检测出平均BMI z评分中0.17单位的差异，检验效能为80%（组内相关系数ICC = 0.01），显著性水平为5%。治疗效果将在STATA中使用混合线性模型进行检验，对儿童基线BMI z评分进行调整，并按学校进行聚类。所有分析将采用意向性分析。二次分析还将对预先指定的学校层面和儿童层面的协变量进行调整。干预措施与常规做法相比的增量成本效益比将为“每质量调整生命年（QALY）成本”。还将评估BMI z评分每变化单位的成本。将使用一系列方法来评估干预措施的实施情况、影响机制和背景因素。
已获得伯明翰大学的生命与健康科学伦理审查委员会以及广州疾病预防控制中心伦理委员会的伦理批准。该试验的主要、次要、过程评估和经济评估结果将通过相关国际同行评审期刊和会议进行传播。
ISRCTN11867516；预结果。
