Complementary feeding: a Global Network cluster randomized controlled trial

描述（由申请人提供）：加上缺乏纯母乳喂养，补充喂养不足或/和不适当是发展中国家发病率和死亡率的主要原因。使用未强化的植物性补充食品，即使是最佳制备，也不能满足某些“问题”微量营养素的需求。特别重要的是铁和锌，如果从6个月大开始定期提供肉类/肝脏，则只能从未强化的食物中获得铁和锌的需求。该提案的广泛目标是确定非强化食品为基础的方法（持续母乳喂养）的多元文化潜力，以实现6-18月龄之间营养全面的饮食，特别是在6-9月龄的挑战性过渡期。我们策略的主要目标是特别鼓励从6月龄开始定期喂食肉类/肝脏。这两个假设包括：1）肉/肝的常规摄入可以在6个月时开始，随后持续; 2）早期引入肉/肝将与显著增加的摄入量和改善铁和锌的状态、增强的身体生长、改善的神经认知发育和降低的传染病发病率相关。受试者（n = 410）将按分组随机接受基于国家/WHO补充喂养指南（对照）或这些指南加上关于从6个月起定期喂养肉/肝的信息（试验）的重复教育信息。具体的信息将基于初步形成性研究的结果，其中将纳入行为变化沟通（BCC）的原则。对于测试集群的参与者，从形成性研究的结果中开发的其他信息将集中在确定负担得起的肉/肝来源，并将其作为常规补充食品提供。信息的传播和培训将通过当地社区卫生服务，由非专业顾问的支持确定的积极偏差模型，以支持照顾者的行为改变。干预的主要功能结局将是6-18个月的线性增长;次要结局包括神经认知测试的表现以及腹泻和下呼吸道感染的发生率。这项试验的积极多国结果将证明BCC教育模式在实现当地以食物为基础的适当补充喂养方法方面的广泛有效性。

DESCRIPTION (provided by applicant): Together with lack of exclusive breastfeeding, inadequate or/and inappropriate complementary feeding is a major cause of morbidity and mortality in the developing world. Use of unfortified plant-based complementary foods, even prepared optimally, cannot meet the needs for certain 'problem' micronutrients. Of special importance are iron and zinc, requirements for which can only be attained from unfortified foods if meat/liver are provided on a regular basis from the age of 6 mo. The broad goal of this proposal is to determine the multicultural potential of a non-fortified food-based approach (with continued breastfeeding), to achieve a nutritionally complete diet between 6-18 mo of age, especially during the challenging transition period from 6-9 mo. The key goal of our strategy will be to specifically encourage the regular feeding of meat/liver from 6 mo of age. The two hypotheses include: 1) that regular intake of meat/liver can be initiated at 6 mo and subsequently sustained; and 2) that the early introduction of meat/liver will be associated with significantly greater intake and improved status of iron and zinc, enhanced physical growth, improved neurocognitive development, and reduced infectious disease morbidity. Participants (n = 410) will be randomized by clusters to receive repetitive educational messages based on national/WHO complementary feeding guidelines (controls) or these guidelines plus messages regarding regular feeding of meat/liver from 6 mo onwards (test). Specific messages will be based on results of initial formative research which will incorporate principles of behavioral change communication (BCC). For the participants in the test clusters, additional messages developed from outcomes of formative research, will focus on the identification of affordable sources of meat/liver and offering these as regular complementary foods. Dissemination of the messages and training will be via local community health services, supported by lay counselors identified on the positive deviance model, to support behavioral change of caregivers. The primary functional outcome of the intervention will be linear growth from 6-18 mo; secondary outcomes include performance on neurocognitive testing and incidence of diarrhea and lower respiratory infection. A positive multi-country outcome of this trial will demonstrate the broad effectiveness of a BCC education model for achieving a local, food-based approach for adequate complementary feeding.