Complementary feeding: a Global Network cluster randomized controlled trial

Complementary feeding: a Global Network cluster randomized controlled trial
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DOI:
10.1186/1471-2431-11-4
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发表时间:
2011-01-13
期刊:
影响因子:
2.4
通讯作者:
McClure, Elizabeth
McClure, Elizabeth
中科院分区:
医学3区
文献类型:
--
作者:
Krebs, Nancy F.;Hambidge, K. Michael;McClure, Elizabeth

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背景:补充喂养不足和不适当是导致资源匮乏地区幼儿发病率和死亡率过高的主要因素。动物源食品尤其被认为是满足微量营养素需求所必需的。然而,该建议的有效性尚未得到系统评估。 方法/设计:一项整群随机有效性试验旨在检验以下假设:每天摄入牛肉作为补充食品 12 个月会比微量营养素强化等热量大米-大豆谷物补充剂带来更高的线性生长速度。该研究正在全球妇女和儿童健康研究网络的 4 个地点进行,这些地点位于危地马拉、巴基斯坦、刚果民主共和国 (DRC) 和赞比亚,这些社区的幼儿发育迟缓率至少为 20%。每个国家将五个组随机分配到每个食物组,每个组有 30 名婴儿。每日肉类或谷物补充剂由社区协调员送到家中,从婴儿 6 个月大开始一直持续到 18 个月。所有参与的母亲都收到了由研究协调员和当地卫生中心的海报提供的营养教育信息,以加强补充喂养做法。结果测量由单独的评估小组在 6、9、12 和 18 个月时获得,包括人体测量学;饮食多样性和多样性得分;铁、锌和维生素 B-12 状态的生物标志物(18 个月);神经认知发育(12 个月和 18 个月);以及整个试验期间感染发病率。该试验由试验指导委员会监督,独立数据监测委员会对试验的安全性和进行进行监督。讨论:该试验的结果将测试从 6 个月大开始每天摄入肉类的功效,如果有益的话,将为全球努力增加当地肉类供应作为幼儿的补充食品提供强有力的理由。
Background: Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.Methods/Design: A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B-12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial.Discussion: Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children.