- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04447209
Dietary Diversity of Young Children During CoVID-19 Outbreak: A Longitudinal Study (CoDDYC)
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- University of Malaya Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Children who participated in the Children of Urban Poverty Iron Project (CUPIP), PPR Lembah Subang 1, Selangor
Children in PPR Kota Damansara, Selangor
Children who attend the Child Health Clinic, UMMC
Description
Inclusion Criteria:
- All well-children aged between 6 months and 6 years
Exclusion Criteria:
- Children with chronic illnesses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Child Health Clinic (CHC)
Control arm - Receives dietary counseling but not given food basket.
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Experimental: Community Children
2-weekly food basket consisting of fresh or minimally processed foods in addition to dietary counseling
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2 weekly Food basket containing fresh foods or minimally processed foods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Minimal Dietary Diversity (MDD) of more than 5 food groups in 24 hours
Time Frame: At study completion, an average of 9 months.
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Number of food groups in 24 hours
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At study completion, an average of 9 months.
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Consumption of fruits and vegetables, pre and post-intervention
Time Frame: At study completion, an average of 9 months.
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percentage of population consuming fruits and vegetables, pre and post-intervention
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At study completion, an average of 9 months.
|
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Consumption of sugar-sweetened foods and beverages, pre and post-intervention
Time Frame: At study completion, an average of 9 months.
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percentage of population consuming sugar-sweetened foods and beverages, pre and post-intervention
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At study completion, an average of 9 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood hemoglobin in children at the start of study and 4 months later
Time Frame: At study completion, an average of 9 months.
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Change in gram/L
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At study completion, an average of 9 months.
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Serum ferritin in children at the start of study and 4 months later
Time Frame: At study completion, an average of 9 months.
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Change in microgram/L
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At study completion, an average of 9 months.
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Height and Weight z-scores, pre and post-intervention
Time Frame: At study completion, an average of 12 months.
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Malnutrition
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At study completion, an average of 12 months.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohammad Y Jalaludin, MBBS MPaeds, University of Malaya Medical Center
Publications and helpful links
General Publications
- World Health Organization. Indicators for assessing infant and young child feeding practices Part 1: Definitions. Geneva: WHO; 2008
- 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
- 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. doi: 10.1093/jn/137.2.472.
- 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. No abstract available.
- 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. doi: 10.1079/phn2005912.
- World Health Organization, Geneva. 2017; Global Nutritional Monitoring Framework: Operational guidance for tracking progress in meeting targets for 2025
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020410-8500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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