Improving Growth and Cognitive Development of the Disadvantaged Young Children by Providing Animal Source Food (ASF) and Psychosocial Stimulation in Resource Poor Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 627
- 试验地点
- 1
- 主要终点
- To change the nutritional status under-two (6-23 mo) year children (a difference of 0.35 SD in the length-for-age z-score) from food insecure, low-income families in rural Bangladesh after receiving comprehensive intervention for 12 months
研究概览
简要总结
- Burden:
The period from birth to two years of age is the "critical window" for the promotion of optimal growth, health, and development. Insufficient quantities and inadequate quality of complementary foods, poor child-feeding practices and high rates of infections have a detrimental impact on growth. Approximately one-third of children less than five years of age in developing countries are stunted, and large proportions are also deficient in one or more micronutrients. An estimated six per cent or six hundred thousand under-five deaths can be prevented by ensuring optimal complementary feeding (CF) only. 2. Knowledge gap:
The unprecedented global social and economic crisis triggered by the COVID-19 pandemic poses grave risks to the nutritional status and survival of young children in low-income and middle-income countries (LMICs) including Bangladesh. In this situation families living below the poverty line may unable to provide their children adequately for meeting their nutritional requirement. In the face of poverty, animal-sourced foods are the first to be dropped from children's diets though these are the most vital protein sources. 3. Hypothesis:
An intervention package (child feeding counselling, food voucher for animal source food, WASH and micronutrient powder) will improve child growth (difference of 0.35 in mean Length-for-Age-Z-score) and cognitive outcome (difference of 3.80 in mean cognitive outcome) in the selected intervention area from rural Bangladesh compared to control area. 4. Objective:
The general objective of this study is to evaluate an intervention package that should improve growth, cognitive development, appropriate complementary feeding practice, and water sanitation and hygiene (WASH) practices of children at risk of stunting in resource poor settings. 5. Methods:
We will use a community-based cluster randomized controlled three arms trial. The trial will be carried out in thirty clusters/wards (two to three villages making up each ward) within six unions of the Atpara Upazila in the Netrokona district. There will be three study groups (209 mothers/infant pairs in each treatment group I, II, and 209 mothers/infant pairs in the control group). The effect of the intervention package will be compared to the control group with similar population demography receiving only counselling on appropriate infant and young child feeding messages.
详细描述
Background:
Management of child malnutrition:
According to WHO report in 2003 Children over six months of age require up to 550 calories every day on top of being breastfed, traditional sources of which may cost up to BDT 40 (50 US cents. In Bangladesh, 2.87 million children under five are coming from the poorest segment (21.8% of the total population), this also includes 1.7 million children under five who belong to extremely poor households surviving on less than USD 1.9 per day (12.9% of the total population). For families surviving on less than USD 1.9 a day, the gross expenditure for their children's complimentary food would be one-fourth of their daily subsistence. This is surreal and unlikely to happen that these families will practice the recommended complementary feeding. As the cost of feeding one child is too high, these households are thus unable to provide their children adequately. In the face of poverty, animal-sourced foods are the first to be dropped from children's diets though these are the most crucial protein sources. There is a need to develop a strategy to support the cost of food supplement especially for children in this critical period what the proposed study is attempting.
Animal Source Food (ASF) Animal Source Foods are dense in a wide range of micronutrients linked to growth and cognitive development (iron, B12, choline), in addition to protein. World Health Organization (2014) described ASF as the best source of high-quality nutrient-dense food for 6-23 months of age children. One egg provides 57% of the RDA of protein and 98% of the adequate intakes (AI) of choline, 88% of vitamin B12, 25-50% of vitamin B6, folate and phosphorus, and 20% of zinc for 7-12-month-old children. Eggs also provide essential fatty acids, including DHA (22:6n-3), crucial for brain development, particularly during early life. This indicates the provision of eggs during the early complementary feeding period could promote cognitive development. Moreover, due to the COVID-19 pandemic, acute malnutrition among young children will be more pronounced due to an acute shortage of food and access to essential health and other services. It is assumed that stunting (chronic malnutrition) may fall back from the current level if no preventive measures have been taken.
Child Malnutrition and Cognitive Development:
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
- Single (Outcomes Assessor)
盲法说明
This is a community based randomized cobtrolled trial. Participants, care provider and investigator will know the intervention. Outcomes assessor (e.g. Anthrpometric measurer and psychosocial stimulation evaluator) will not know about the participant allocation and major outcome of the intervention.
入排标准
- 年龄范围
- 6 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-15 months
- •Households having moderate to severe food insecurity
- •Households having monthly income < BDT 10,000
- •Households dependent on irregular income
- •Households have plan to stay in the study area for next 1 year
- •Households not involved with any nutrition or social safety net programme
排除标准
- •Children aged less than 6 months
- •Children aged more than 15 months
- •Households having regular income and monthly income is more than BDT 10000
- •Households involved in any nutrition or social safety net programme
结局指标
主要结局
To change the nutritional status under-two (6-23 mo) year children (a difference of 0.35 SD in the length-for-age z-score) from food insecure, low-income families in rural Bangladesh after receiving comprehensive intervention for 12 months
时间窗: Anthropometry will be collected in every three months till 12 months
• Difference in length-for-age z-score after 12 months (length measured in centimeters) (intervention vs control)
To change the developmental outcome of the under-two (6-23 mo) year children
时间窗: Child developmental assessment will be done before and after 12 months of intervention
Differences in children's cognition, language (expressive and receptive), motor (fine and gross motor) and behavioural development will be assessed by Bayley Scales after 12 months (intervention vs control)
次要结局
- To change the dietary diversity of the under-two (6-23 mo) year children(• Differences in percentage of children at 6, 9, 12 months who receive complementary feeds • Differences in percentage of children consuming foods from >4 food groups)
- To change hand washing and sanitation practice(Hand washing and sanitation practice assessment will be done before and after 12 months of intervention)