Grant Abstract: Complementary feeding: a Global Network cluster randomized controlled trial

Grant Number: 5U01HD040657-07
Project Title: Complementary feeding: a Global Network cluster randomized controlled trial

Abstract: 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.

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