NCT04447209

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

June 17, 2020

Last Update Submit

February 13, 2025

Conditions

Keywords

Dietary diversitymicro-nutrient adequacyyoung childrenurban settingsconsumption of sugar sweetened foods and beverages

Outcome Measures

Primary Outcomes (4)

  • Minimal Dietary Diversity (MDD) of more than 5 food groups in 24 hours

    Number of food groups in 24 hours

    At study completion, an average of 9 months.

  • Consumption of fruits and vegetables, pre and post-intervention

    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

    percentage of population consuming sugar-sweetened foods and beverages, pre and post-intervention

    At study completion, an average of 9 months.

  • Height and Weight z-scores, pre and post-intervention

    Malnutrition

    At study completion, an average of 9 months.

Secondary Outcomes (2)

  • Blood hemoglobin in children at the start of study and 4 months later

    At study completion, an average of 9 months.

  • Serum ferritin in children at the start of study and 4 months later

    At study completion, an average of 9 months.

Study Arms (2)

Child Health Clinic (CHC)

NO INTERVENTION

Control arm - Receives dietary counseling but not given food basket.

Community Children

EXPERIMENTAL

2-weekly food basket consisting of fresh or minimally processed foods in addition to dietary counseling

Other: 2-weekly Food baskets

Interventions

2 weekly Food basket containing fresh foods or minimally processed foods.

Community Children

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All well-children aged between 6 months and 6 years

You may not qualify if:

  • Children with chronic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (6)

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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 17237329BACKGROUND
  • 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.

    PMID: 27266965BACKGROUND
  • 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.

    PMID: 16923296BACKGROUND
  • World Health Organization, Geneva. 2017; Global Nutritional Monitoring Framework: Operational guidance for tracking progress in meeting targets for 2025

    BACKGROUND

Study Officials

  • Mohammad Y Jalaludin, MBBS MPaeds

    University of Malaya Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 25, 2020

Study Start

June 6, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2023

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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

Locations