Malnutrition Clinical Trial
Official title:
A Novel Sustainable Complementary Feeding Product for Infants and Young Children in the Democratic Republic of Congo: Caterpillar Cereal
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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