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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04447209
Other study ID # 2020410-8500
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 6, 2020
Est. completion date March 31, 2022

Study information

Verified date October 2022
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The 2019-2020 coronavirus pandemic has had far-reaching consequences beyond the spread of the disease. Quarantine measures during a public health pandemic can be particularly detrimental to urban poor families and affect the dietary diversity and food security. This can disproportionately affect young children aged 6 and below, and severely impact those <2 years. Sudden unemployment may result in an unexpected reduction in income that will place pressure on daily budgets for food. Children of families may not have access to foods of adequate diversity that will enable them to meet their macro and micronutrient requirements for growth and development, especially during the Movement Control Order (MCO). The study plans to monitor and evaluate dietary diversity in young children's food intake after the MCO and use the collected information to direct targeted food aid to address observed macro- and micronutrient deficiencies among the urban vulnerable group.


Description:

Children are the future to our society. The first thousand days of life, starting from conception till one's second birthday is a critical period of cognitive and physical development. It is the most sensitive period where brain development is most receptive to positive nutrition. Any form of malnutrition, especially during this golden time frame, can lead to irreversible effects to growth, health, education and future career attainment to our potential leaders, which in turn can be a barrier to human development. The CoVID outbreak is a unique period in recent human history where drastic public health measures such as MCO for an extended period of time has to be implemented nation-wide. These measures have untold severe consequences on the food security of the vulnerable urban group, in particular the young children whose brains require diverse micronutrients to support the rapid growth. These micronutrients can only be obtained from a daily diet that is equally diverse, especially from fresh vegetables and fruits which will be short in supplies. These perishable food items are not usually included in food aids, thus the child may have to subsist on staple-rich diet which are energy-dense but nutrient-poor. These dietary practices are associated with negative health outcomes. Thus by monitoring dietary diversity of the children, we hope to better inform food aid organisations to consider the inclusion of healthier food options to prevent micronutrient deficiencies.


Recruitment information / eligibility

Status Completed
Enrollment 469
Est. completion date March 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 6 Years
Eligibility Inclusion Criteria: - All well-children aged between 6 months and 6 years Exclusion Criteria: - Children with chronic illnesses

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary counselling on Food Groups according to IYC Feeding practices, WHO
Monitoring of Dietary diversity and growth

Locations

Country Name City State
Malaysia University of Malaya Medical Center Kuala Lumpur Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

Cusick SE, Georgieff MK. The Role of Nutrition in Brain Development: The Golden Opportunity of the "First 1000 Days". J Pediatr. 2016 Aug;175:16-21. doi: 10.1016/j.jpeds.2016.05.013. Epub 2016 Jun 3. — View Citation

Kennedy GL, Pedro MR, Seghieri C, Nantel G, Brouwer I. Dietary diversity score is a useful indicator of micronutrient intake in non-breast-feeding Filipino children. J Nutr. 2007 Feb;137(2):472-7. — View Citation

Steyn NP, Nel JH, Nantel G, Kennedy G, Labadarios D. Food variety and dietary diversity scores in children: are they good indicators of dietary adequacy? Public Health Nutr. 2006 Aug;9(5):644-50. — View Citation

Working Group on Infant and Young Child Feeding Indicators. Developing and validating simple indicators of dietary quality of infants and young children in developing countries: Additional analysis of 10 data sets. Report submitted to: the Food and Nutrition Technical Assistance (FANTA) Project/Academy for Educational Development (AED), July 2007

World Health Organization, Geneva. 2017; Global Nutritional Monitoring Framework: Operational guidance for tracking progress in meeting targets for 2025

World Health Organization. Indicators for assessing infant and young child feeding practices Part 1: Definitions. Geneva: WHO; 2008

Outcome

Type Measure Description Time frame Safety issue
Primary Minimal Dietary Diversity (MDD) of more than 5 food groups in 24 hours Number of food groups in 24 hours 24 hours
Primary Height Height increase in centimetres 4 months
Primary Weight Weight increase in kilogram 4 months
Primary Meal frequencies in past 24 hours Number of meal frequencies 24 hours
Secondary Blood hemoglobin in children at the start of study and 4 months later Change in gram/L 4 months
Secondary Serum ferritin in children at the start of study and 4 months later Change in microgram/L 4 months
Secondary Consumption of sugar and processed foods Number of types 1 month
Secondary Food Aids received Types of food groups 1 month
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