Breastfeeding Promotion RCT and Child Metabolic Syndrome

描述(由申请人提供)：流行病学研究表明，母乳喂养与代谢综合征各部分发生的风险降低有关。然而，儿童时期的母乳喂养和新陈代谢风险因素都是社会模式，很可能只有在大型随机对照试验中才能令人信服地证明母乳喂养的明确影响。这项申请是基于对17,046名健康婴儿的9年随访，这些婴儿最初参与了促进母乳喂养干预试验(PROBIT)，这是一项在白俄罗斯共和国进行的整群随机试验。这项干预产生了两组完全不同的长时间纯母乳喂养，提供了一个独特的机会来测试促进母乳喂养对儿童代谢综合征的影响，目的是进行处理分析。这项应用的总体目标是在随机对照试验的背景下，调查母乳喂养促进干预对儿童代谢综合征及其成分和脂联素水平的影响。这项应用利用了有史以来在人类哺乳领域进行的最大规模的试验。12个月和6.5年的高随访率(80%)证明了它的可行性。这项试验是在白俄罗斯进行的，因为那里的妇产科医院的做法与20至30年前北美和西欧的做法类似，因此在干预和对照研究地点之间提供了更大的潜在对比。尽管白俄罗斯在许多社会文化方面与美国不同，但它是一个相对发达的国家。因此，这项拟议研究的结果可能会为美国和其他地方的政策提供参考。通过在9岁时对已经登记的Probit参与者进行跟踪调查，并在加拿大卫生研究所和欧盟已经获得共同资助的情况下，拟议的项目提供了一种相对经济的方式，以有力地回答有关儿童代谢综合征前驱的重大公共卫生重大科学问题。

DESCRIPTION (provided by applicant): Epidemiologic studies indicate that breastfeeding is associated with reduced risk of developing components of the metabolic syndrome. Breastfeeding and metabolic risk factors in childhood are both socially patterned, however, and it is likely that the unconfounded effects of breastfeeding can be convincingly demonstrated only in a large randomized controlled trial. This application is based on the 9-year follow-up of 17,046 healthy infants who originally participated in the Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized trial in the Republic of Belarus. The intervention produced two groups with substantially different exposure to prolonged exclusive breastfeeding, providing a unique opportunity to test, in an intention to treat analysis, the effect of breastfeeding promotion on the metabolic syndrome in childhood. The overall goal of this application is to investigate the influence of a breastfeeding promotion intervention on the development of the metabolic syndrome, its components, and adiponectin levels in childhood within the setting of a randomized controlled trial. This application takes advantage of the largest trial ever undertaken in the area of human lactation. Its feasibility is demonstrated by the high (> 80%) follow up rates already achieved at 12 months and 6.5 years. The trial was carried out in Belarus because maternity hospital practices there are similar to those in North America and Western Europe 20 to 30 years ago and thus provide a greater potential contrast between intervention and control study sites. Although different in many sociocultural respects from the United States, Belarus is a relatively developed country. The results of the proposed study are therefore likely to inform policy in the US and elsewhere. By following up the already enrolled PROBIT participants at 9 years of age, and with already secured co-funding from the Canadian Institutes of Health Research and the European Union, the proposed project provides a relatively economical way to answer robustly scientific questions of major public health importance regarding the precursors of the metabolic syndrome in children.