A Novel Sustainable Complementary Feeding Product for Infants and Young Children in the Democratic Republic of Congo: Caterpillar Cereal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Incidence of Stunting of Linear Growth
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 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.
详细描述
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:
- Feed thickened gruel or cereals every day
- Feed infant/toddler at least 3 times a day
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born in study communities who will reach 6 months of age during the six month period after initiation of the study
排除标准
- •Infants likely to receive free or subsidized complementary foods (or infant formula)
- •Families likely to relocate during the study period
- •Infants with known congenital anomaly
- •Infants of multiple birth
- •Infants with neurological deficit apparent at the time of enrollment
结局指标
主要结局
Incidence of Stunting of Linear Growth
时间窗: 18 months of age
Stunting of linear growth will be defined as a height-for-age Z score less than 2 using WHO standards.
次要结局
- Rate of Head Growth(18 months of age)
- All Cause Mortality(6-18 months)
- Iron Deficiency Anemia(18 months)
- Infectious Disease Morbidity(6-18 months)
- Incidence of wasting(18 months of age)
- Developmental Outcome(18 months of age)
- Compliance(6-18 months)
研究者
Carl Bose, MD
Prinicipal investigator
University of North Carolina, Chapel Hill