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组分发生风险降低相关。然而，母乳喂养和儿童期代谢危险因素都是社会模式的，而且母乳喂养的无混杂效应可能只有在大型随机对照试验中才能令人信服地证明。本申请基于对17，046名健康婴儿的9年随访，这些婴儿最初参加了促进母乳喂养干预试验（PROBIT），这是白俄罗斯共和国的一项随机分组试验。干预产生了两组有实质性不同的暴露于长期纯母乳喂养，提供了一个独特的机会来测试，在意向治疗分析，母乳喂养的促进对代谢综合征在儿童期的影响。本申请的总体目标是在一项随机对照试验的背景下，研究母乳喂养促进干预对儿童代谢综合征及其组分和脂联素水平的影响。该应用利用了人类哺乳领域有史以来最大规模的试验。12个月和6.5年的高随访率（> 80%）证明了其可行性。该试验在白俄罗斯进行，因为那里的妇产医院实践与20至30年前的北美和西欧相似，因此在干预和对照研究中心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，拟议研究的结果可能会为美国和其他地方的政策提供信息。通过跟踪已经登记的9岁的PROBIT参与者，以及已经获得的加拿大卫生研究所和欧盟的共同资助，拟议的项目提供了一种相对经济的方式来回答有关儿童代谢综合征前体的重大公共卫生重要性的科学问题。

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.