Malnutrition Clinical Trial
Official title:
Caterpillar Cereal: Maternal and Infant Acceptability
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 micronutrients. Although supplementation with selected micronutrients 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. Maternal and infant acceptability will be evaluated in 20 mothers and their 8 month old infants. The investigators hypothesize that this cereal will be accepted by both mothers and infants: acceptability will be based on a priori definitions.
In preparation for a controlled study of the efficacy of daily intake of caterpillar cereal
versus the usual diet from 6 to 18 months of age in reducing the rate of stunting of linear
growth, and the improvement in other health outcomes, we will conduct an acceptability
trial. In this trial, we will test the mothers' acceptance of the caterpillar cereal and
their willingness to feed their young children this product. We will also test the infants'
acceptance and their capacity to consume quantities required in the controlled trial
necessary to deliver the desired quantities of micronutrients.
Study Design
A cohort of 20 mother-infant dyads will be recruited. The site of recruitment will be the
area Health Center. Infants will be between 8 and 10 months of age and will have no major
health problems. Infants with minor, inter-current illnesses at the time of recruitment that
might interfere with oral intake will be excluded. After informed consent, maternal and
infant acceptability will be tested using the methods described below.
Maternal Acceptability
Mothers will be provided with a 30 g portion of caterpillar cereal and will be instructed in
the proper technique for preparation. After preparation, mothers will be asked to evaluate
five features of the cereal. They will also be asked to provide their overall impression of
the cereal. In each category, the evaluation will be assigned a numerical score using a
five-part Likert scale, from "like very much" to "dislike very much".
The evaluation will be conducted by the Community Coordinator (CC) who will provide
instruction about cereal preparation and administer the evaluative tool. Each evaluation
will be conducted confidentially. Mothers will not be aware of the response of other
mothers. At the conclusion of a one-week period of feeding (see below), a questionnaire will
be administered to assess mothers' attitudes about their willingness to participate in a
one-year study of cereal feeding.
We do not intend to evaluate their attitudes about food preparation. The recommended
preparation technique of the caterpillar cereal is very similar to preparation of enriched
soy cereal in our ongoing complementary feeding study. This involves boiling water and
cooking the cereal for approximately three minutes. Although this preparation technique is
burdensome, it has not compromised compliance in the ongoing study. Therefore, we would
expect a similar response from mothers in the proposed study.
Infant Acceptability
Following the evaluation of maternal acceptability, each mother will be provided with a
one-week supply of caterpillar cereal (7 individual packets containing 30 g each). She will
be instructed to begin daily feedings on the following day, and to continue until the cereal
packets have all been used. The first feeding will occur during a home visit by the CC, who
will repeat the preparation instructions, and will observe the first feeding. The CC will
return to the home on alternate days throughout the week to reinforce instructions regarding
preparation, and to make observations about infant feeding habits. Although frequent visits
may influence the likelihood of maternal compliance and hence may mislead investigators
about maternal acceptability, it will not effect infant acceptability.
Mothers will be instructed not to feed the cereal to other household members, and will be
asked to return uneaten cereal to the original packet for collection by the CC at the end of
the week.
On the 8th day, the day following the completion of use of the cereal, the CC will return to
the home for the purpose of data collection. The CC will administer a 24-hour dietary
recall, and collect all cereal packets. In addition, mothers will be asked questions about
the infant's health status.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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