Dietary Diversity of Young Children During CoVID-19 Outbreak: A Longitudinal Study (CoDDYC)

May 17, 2026 updated by: Lucy Lum Chai See, University of Malaya
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • University of Malaya Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 6 years (Child)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Child Health Clinic (CHC)
Control arm - Receives dietary counseling but not given food basket.
Experimental: Community Children
2-weekly food basket consisting of fresh or minimally processed foods in addition to dietary counseling
Other: 2-weekly Food baskets
2 weekly Food basket containing fresh foods or minimally processed foods.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Minimal Dietary Diversity (MDD) of more than 5 food groups in 24 hours
Time Frame: At study completion, an average of 9 months.
Number of food groups in 24 hours
At study completion, an average of 9 months.
Consumption of fruits and vegetables, pre and post-intervention
Time Frame: At study completion, an average of 9 months.
percentage of population consuming fruits and vegetables, pre and post-intervention
At study completion, an average of 9 months.
Consumption of sugar-sweetened foods and beverages, pre and post-intervention
Time Frame: At study completion, an average of 9 months.
percentage of population consuming sugar-sweetened foods and beverages, pre and post-intervention
At study completion, an average of 9 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood hemoglobin in children at the start of study and 4 months later
Time Frame: At study completion, an average of 9 months.
Change in gram/L
At study completion, an average of 9 months.
Serum ferritin in children at the start of study and 4 months later
Time Frame: At study completion, an average of 9 months.
Change in microgram/L
At study completion, an average of 9 months.
Height and Weight z-scores, pre and post-intervention
Time Frame: At study completion, an average of 12 months.
Malnutrition
At study completion, an average of 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohammad Y Jalaludin, MBBS MPaeds, University of Malaya Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020410-8500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share demographic data of subject and family, baseline anthropometric measurements as well as dietary diversity of children in various locales

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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