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发病风险降低有关。然而，母乳喂养和儿童时期的代谢风险因素都是社会模式，母乳喂养的明确影响可能只有在大型随机对照试验中才能令人信服地证明。这项应用是基于对最初参加促进母乳喂养干预试验（PROBIT）的17,046名健康婴儿的9年随访，PROBIT是白俄罗斯共和国的一项集群随机试验。干预产生了两组在长期纯母乳喂养方面有很大不同的人，为测试提供了一个独特的机会，目的是为了治疗分析，促进母乳喂养对儿童代谢综合征的影响。本应用程序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成部分和脂联素水平发展的影响。这个应用程序利用了有史以来在人类哺乳领域进行的最大的试验。12个月和6.5年随访率均达到80%，证明了该方法的可行性。试验在白俄罗斯进行，因为白俄罗斯妇产医院的做法与20至30年前北美和西欧的做法相似，因此在干预和对照研究地点之间提供了更大的潜在对比。虽然白俄罗斯在许多社会文化方面与美国不同，但白俄罗斯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国家的政策提供参考。通过对已登记的PROBIT参与者在9岁时进行随访，并已获得加拿大卫生研究所和欧洲联盟的共同资助，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.