Improving Growth and Cognitive Development of the Disadvantaged Young Children in Resource Poor Setting
NCT05805514 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 627
Last updated 2023-04-10
Summary
1. 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.
Conditions
- Complementary Feeding
Interventions
- OTHER
-
Animal source of food and psychosocial stimulation
209 mother-child pair will receive the animal source of food and psychosocial stimulation for 12 months. Child will be recruited within 6-12 months.
- OTHER
-
Animal source of food
209 mother-child pair will receive the animal source of food for 12 months. Child will be recruited within 6-12 months.
- OTHER
-
Control
209 mother-child pair will receive the control package for 12 months. Child will be recruited within 6-12 months.
Sponsors & Collaborators
-
International Centre for Diarrhoeal Disease Research, Bangladesh
lead OTHER
Principal Investigators
-
Gulshan Ara, MSc, MPH · International Centre for Diarrhoeal Disease Research, Bangladesh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 15 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-20
- Primary Completion
- 2024-07-31
- Completion
- 2024-12-31
Countries
- Bangladesh
Study Locations
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