Caterpillar Cereal: Maternal and Infant Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maternal acceptability
研究概览
简要总结
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.
详细描述
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".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any mother-infant dyad living within each a study community in the Equateur Province. Infants must be 8-10 months of age at the time of recruitment.
排除标准
- •Infants with minor inter-current illness that may interfere with oral intake
- •Infants of multiple gestation births
- •Infants with congenital anomalies
- •Infants likely to receive free or subsidized complementary foods (or infant formula)
研究组 & 干预措施
Feeding group
The feeding group will include 20 mother/infant dyads. The infants will be between 8 and 10 months of age.
干预措施: caterpillar cereal (Dietary Supplement)
结局指标
主要结局
Maternal acceptability
时间窗: Maternal acceptability will be measured on the first day of the trial.
Maternal acceptability will be defined as a median score for each of 5 features (smell, taste, texture, color, consistency, overall impression) of 3 or greater on a 5 point Likert scale.
Infant acceptability
时间窗: Infant acceptability will be measured during the one week study period.
Each mother will be provided with a one-week supply of caterpillar cereal and will be instructed to begin daily feedings for a period of one week. Infant acceptability will be defined as the consumption of greater than 75% of the total cereal allotment by all infants during the last four days of feeding.
次要结局
- Infant tolerance(This outcome will be measured throughout the one week intervention.)
研究者
Carl Bose
Prinicipal Investigator
University of North Carolina, Chapel Hill