Complementary feeding: a Global Network cluster randomized controlled trial

说明(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。使用未经强化的植物性补充食品，即使是经过最佳烹调，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，只有在从6个月龄起定期提供肉类/肝脏的情况下，才能从非强化食品中获得铁和锌的需求。这项建议的广泛目标是确定非强化食物为主的方法(持续母乳喂养)的多元文化潜力，以在6-18个月龄之间实现营养完整的饮食，特别是在6-9个月的具有挑战性的过渡期。我们战略的主要目标将是特别鼓励从6个月龄起定期喂食肉/肝。这两个假设包括：1)肉/肝的常规摄取可以在6个月开始并随后保持；以及2)肉/肝的早期引入将与显著增加的摄入量和改善铁和锌的状况、促进身体生长、改善神经认知发育和降低传染病发病率相关。参与者(n=410)将被随机分组，根据国家/世卫组织补充喂养指南(对照)或这些指南加上关于从6个月起定期喂食肉类/肝脏的信息(测试)，接受重复的教育信息。具体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。对于测试组的参与者，根据形成性研究的结果制定的额外信息将侧重于确定负担得起的肉类/肝脏来源，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机构进行，并由积极偏离模式确定的非专业顾问提供支持，以支持照顾者的行为改变。干预的主要功能结果将是6-18个月的线性增长；次要结果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。这项试验在多个国家取得的积极成果将证明，在实现当地以食物为基础的适当补充喂养方法方面，BCC教育模式具有广泛的有效性。

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.