First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
Condition: Complementary Feeding; Infant Growth
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aims of this project is to determine the impact of a daily intake of one half
      ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18
      mo) on linear growth velocity, zinc and iron intakes and status, brain growth and
      neurocognitive development, and infectious disease morbidity in populations traditionally
      dependent on non-micronutrient fortified plant foods for complementary feeding.
    

Detailed description: 
      Inadequate and inappropriate complementary feeding are major factors contributing to excess
      morbidity and mortality in young children. Prominent among nutrient inadequacies are those of
      iron and zinc. While huge campaigns are being mounted to fortify complementary foods and to
      distribute supplements, the effectiveness of these programs is generally uncertain and they
      do not reach millions of rural poor. By comparison, little support is being given to local
      food-based solutions. These not only require diversity of plant foods but appear to require
      the inclusion of meat to achieve zinc and iron requirements. Local supplies of meat are
      achievable but only with a concerted international and local effort. To justify this effort
      requires a multi-site efficacy study, the results of which, if positive, will leave no doubt
      that the effort required to provide sustainable local sources of meat for complementary feeds
      is worthwhile. The principal hypothesis to be tested is that daily intake of beef (1 oz/d for
      6-12 mo and 1.5 oz/d for 12-18 mo) added to usual primarily plant-derived complementary feeds
      plus selected repetitive nutrition education messages results in greater linear growth
      velocity than does a micronutrient (including Zn and Fe) fortified equi-caloric cereal/legume
      supplement plus the same educational messages. Participants from four sites in the Global
      Network which have stunting rates > 20%, i.e. Guatemala, Pakistan and Zambia will be
      randomized by clusters to receive either ½ oz lyophilized beef (equivalent to 1 oz cooked
      beef)/d or the equi-caloric micronutrient-fortified plant-based supplement (both increasing
      by 50% at age 1 year). Both groups will receive three repetitive messages delivered by study
      coordinators and through the local health system as part of integrated health care. These
      are: provide a thick puree/gruel; feed complementary foods at least three times per day; and
      maximize dietary diversity. These interventions will be preceded by messages to promote
      exclusive breast feeding until 6 months and to start complementary feeding promptly at that
      time as far as possible. The meat or fortified cereal supplement will be provided daily in a
      group setting for each cluster; as necessary the food intervention and messages will be
      delivered at home by the assigned community coordinator or alternate. Outcome measures,
      obtained by a separate group of local, trained assessment workers, include: longitudinal
      linear growth between 6-18 months (primary outcome); weight and head circumference;
      assessment of dietary variety and diversity at 6,9,12, and 18 months; indices of iron, zinc
      and Vitamin B12 status at 18 months; neurocognitive development at 18 months; and incidence
      of diarrhea and lower respiratory infections. A positive multi-country, multi-culture outcome
      of this trial will demonstrate the efficacy of a regular intake of meat commencing at age 6
      months to achieve nutritionally complete complementary feeding and will provide a strong
      rationale for global efforts to enhance local supplies of meat and achieve acceptance of
      meats as complementary food.
    

Intervention name(s): Lyophilized meat; Cereal
Intervention type(s): Other; Other
Intervention description(s): Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo); Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Complementary feeding; Infant growth; Developing countries