Introduction of Fish Early in the Complementary Feeding Period to Improve Infant Growth in Samfya District, Luapula Province, Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Linear growth
研究概览
简要总结
The aim of the study is to provide proof that giving fish during early complementary feeding improves infant linear growth outcomes.
详细描述
Stunting is an irreversible consequence of inadequate growth during the early life of a child in the absence of appropriate interventions before the age of 2 years. Stunting affect 151 million (22.2%) of children worldwide. World Health Organisation (WHO) global nutrition target for 2025 is to reduce the number of stunted children under-five years by 40%.3,4 The first 1000 days (conception to 2years) is crucial for later development. It is also the period when stunting prevalence is at its highest. In Zambia, the stunting prevalence is 40%8 , 43% in Luapula province with Samfya district statistics as high as 49%.
Good complementary feeding of children contributes to the positive characteristics of growth trends observed in developed countries. It is a period of introducing solids and age of accelerated growth. Improved linear growth in food insecure homes is achievable by using locally available foods that are sustainable and usually acceptable. The role of fish's contribution to child's optimal growth and development in the first 1 000 days in Zambia has been reviewed. A food consumption survey also shows that fish is one of the highly consumed protein foods in low-income households in Zambia.To the investigators knowledge, fish has not been assessed as an early complementary food for infants aged 6 months in Zambia. This study will investigate the effect of providing dry fish powder to 6 months old infants (over a 6 months period) on their linear growth Research Question Can the introduction of fish during early complementary feeding improve infant linear growth in Samfya district, Zambia? Study Aim The aim of this study is to determine if the introduction of fish during early complementary feeding improves infant's linear growth outcomes.
Objectives Primary Objective The primary objective of the study is to evaluate the effect of introducing fish during early complementary feeding on growth outcomes of infants in Samfya district, Zambia.
Secondary Objectives
- To determine the prevalence of stunting in 6-months old children in the study area.
- To determine the prevalence of stunting in 6-months old children in the study area.
- To determine basic and underlying (socio-demographic, infants/maternal history) factors associated with stunting, wasting and underweight in the study area
- To determine the prevalence of fish allergy in the study area
- To assess the acceptability of fish powder as an early complementary food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
During grinding of sorghum powder, roasted small fish (3g/100g of sorghum) was added to the sorghum to provide a similar fish aroma as the fish product. The fish powder (12g)/ sorghum powder (12g) was then pre-packed in small plastic sachets. The participant and the field workers (research assistants and health workers) are blinded while the principal investigator (PI) is not blinded.
入排标准
- 年龄范围
- 6 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 6 months attending under-five clinic at the sampled RHC. Infants should ideally be 6 months of age however, the study will provide leeway of 2 weeks, and therefore infants falling within the age range 5.5 - 6.5 months may be included. If a 5.5-month-old infant has however not been started with complementary food, the mother will be advised to only start at the age of 6 months with the product.
- •Infants whose mothers give written consent
- •Infants whose mothers have no plans of moving away during the study period
排除标准
- •Infants with, chronic or congenital diseases/disorders that may affect the growth of the children. These may include Down syndrome, cerebral palsy, spina bifida and any other related condition.
- •Premature infants
- •infected infants
研究组 & 干预措施
Control arm
Infants will be given fish powder called sorghum powder for a period of 6 months from the time they are 6 months up to the time they are 12 months.
干预措施: Sorghum powder (Dietary Supplement)
Intervention arm
Infants will be given fish powder called Chisense (Potamothrissa acutirostris) for a period of 6 months from the time they are 6 months up to the time they are 12 months.
干预措施: Fish Powder (Dietary Supplement)
结局指标
主要结局
Linear growth
时间窗: At baseline (6 months), 7,8,9,10,11 and 12 months.
Mean change from baseline in length-for-age Z-scores at 7, 8, 9,10,11 and 12 months old.:WHO 2006 Growth Standards
次要结局
- The percentages (%) of infants who will be underweight and wasted in the study.(At baseline (6 months) 7, 8, 9,10,11 and 12 months)
- The percentage (%) of infants who will be allergic to fish .(6 months)
- Acceptability of fish powder as an early complementary food:(At end-line of the study (when infants are 12 months old))
- The percentage (%) of infants who will be stunted.(At baseline (6 months) 7, 8, 9,10,11 and 12 months)
- Factors associated with stunting, wasting and underweight in the study area.(After collecting baseline information (When infants are 6 months old))
研究者
Given Chipili
Principal Investigator
Mukuba University