Acceptability of a Cereal for Complementary Feeding of Infants and Young Children Made From Caterpillars
Condition: Malnutrition; Stunting of Growth
MeSH terms: Malnutrition; 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 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.
    

Detailed description: 
      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 name(s): caterpillar cereal
Intervention type(s): Dietary Supplement
Intervention description(s): A 30 gram portion of a cereal containing one part dried, ground caterpillar, one part corn flour and small quantities of sugar and palm oil will be evaluated by the mothers and then fed daily for seven days to infants.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: infant nutrition; complementary feeding; malnutrition; stunting of growth