Efficacy of Caterpillar Cereal for Complementary Feeding in the Democratic Republic of Congo
Condition: Malnutrition; Stunting of Growth; Iron Deficiency Anemia; Neurodevelopmental Impairment; Infectious Diseases Morbidity
MeSH terms: Communicable Diseases; Infections; Anemia, Iron-Deficiency; Malnutrition; Iron Deficiencies; Growth Disorders
Study type: Interventional

Summary: 
      Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer
      from stunting of linear growth by 12 months of age. Stunting presumably results from breast
      milk supplementation after 6 months of age with complementary foods (CF) that provide
      inadequate protein and micro-nutrients. Although supplementation with selected
      micro-nutrients may avoid certain deficiency states, CF with animal source foods may be
      necessary to avoid stunting. Meat is not readily available in many Central African countries.
      However caterpillars, which are locally available and abundant, are a common staple in adult
      diets and may be a suitable substitute for animal source proteins in CF. The investigators
      developed a cereal made from dried caterpillars that has a nutrient content that appears to
      be ideal for CF and demonstrated maternal and infant acceptability. This study will
      investigate the efficacy in prevention of stunting of growth resulting from inadequate
      complementary foods.

      A sub-study will evaluate the biologic effects of the caterpillar cereal to determine whether
      caterpillar cereal prevents iron deficiency anemia, reduces the incidence of
      neurodevelopmental impairment or infectious diseases.
    

Detailed description: 
      A randomized, controlled trial will be conducted in the Equateur Province. The study will be
      a cluster randomized, non-masked controlled trial of a daily intake of caterpillar cereal
      (Cereal Arm) versus the usual diet provided by the family (Traditional Diet Arm) from 6 to18
      months of age. Eight communities (clusters) will be randomized to either the Cereal Arm or
      the Traditional Diet Arm of the study. A community will be comprised of approximately 10 to
      12 rural villages served by one Health Center. Each Cereal community will be paired with a
      Traditional Diet community.

      Educational Information

      All participants will be provided with general education that will include: 1) critical
      messages about infant feeding and 2) instruction about hand hygiene and food preparation. The
      primary educators will be the Community Coordinators (CCs; specially-trained research nurses)
      working with the Health Center nurses. Messages will be delivered and reinforced with
      pictorial aids. Mothers in both arms will receive three repetitive messages to reinforce
      selected features of World Health Organization (WHO) recommendations for complementary
      feeding:

        1. Feed thickened gruel or cereals every day

        2. Feed infant/toddler at least 3 times a day

        3. Maximize local food diversity

      Cereal Arm All infants in communities randomized to the Cereal Arm will receive once-daily
      servings of caterpillar cereal (30 g from 6-12 months of ages and 45 g from 12-18 months of
      ages). Study food will be delivered to homes weekly by CCs, who will also observe feedings of
      the cereal during the home visit. Feedings will be observed 3x/week for the first 3 weeks
      after enrollment, then 1x/week until 18 months of age. Parents and other care providers will
      receive specific instructions about cereal preparation and general education about feeding
      practices, food preparation and hygiene. This information will be reinforced during weekly
      visits.

      Traditional Diet Arm Infants in communities randomized to the Traditional Diet Arm will not
      receive food supplements. Parents and other care providers in this arm of the study will
      receive general education about feeding practices, food preparation and hygiene, with weekly
      reinforcement.

      Study Population A total of 220 infants (approximately 27 from each community; 110 infants in
      each arm) will be enrolled in the study. Records of all births within study communities will
      be obtained from local Health Center records. When infants reach 5 months of age, caregivers
      of randomly selected infants will be approached by CCs to seek consent for participation in
      this study. They will be supported by the Provincial Coordinator (the physician who oversees
      community-based studies conducted by the Kinshasa School of Public Health-University of North
      Carolina Partnership) who will hold group information meetings to introduce the study to
      community leaders.
    

Intervention name(s): Caterpillar Cereal
Intervention type(s): Dietary Supplement
Intervention description(s): Infants will receive once-daily servings of caterpillar cereal (30 g from 6-12 months of ages and 45 g from 12-18 months of ages). Study food will be delivered to homes weekly by Community Coordinators, who will also observe feedings of the cereal during the home visit. Feedings will be observed 3x/week for the first 3 weeks after enrollment, then 1x/week until 18 months of age. Parents and other care providers will receive specific instructions about cereal preparation and general education about feeding practices, food preparation and hygiene. This information will be reinforced during weekly visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: infant nutrition; complementary feeding; malnutrition; stunting of growth