Nutrition of Urban-poor Children

April 7, 2025 updated by: University of Malaya

The Impact of Nutritional Intervention in Young Children in PPR Lembah Subang 1: A Retrospective Study

The investigators undertook a program to promote the consumption of healthy foods and reduce the prevalence of malnutrition of children below the age of 5 years in an urban-poor community, by 10% year-on-year through nutrition education and the provision of healthy food. The main purpose of the study is to determine the impact of these nutrition intervention programs on the nutritional status of children under-5 in Selangor.

This retrospective pre-post intervention study will use data collected from 2 previous studies that were carried out between July 2020 to May 2021 (Eat Healthy Project 1.0) and March 2022 to December 2023 (Eat Healthy Project 2.0). The 2 studies had been approved by the Medical Research and Ethics Committees of University Malaya Medical Centre (UMMC) and the Ministry of Health, Malaysia and registered with the National Medical Research Registry (NMRR).

The main outcome measures were:

  1. Improved dietary practices, in particular, an increase in the proportion of children who meet the minimum dietary diversity score of 5 food groups, post-intervention.
  2. An increase in proportion of children consuming fruits and vegetables and a decrease in proportion of children consuming sugar-sweetened foods and beverages post-intervention.
  3. A decrease in prevalence of malnutrition - underweight, wasting and stunting. The comparator will be urban-poor children attending a Child Health clinic who had received nutritional education but no provision of food supplementation.

Study Overview

Detailed Description

The primary objectives:

  1. To compare dietary diversity practices of children, based on the WHO 8 food groups and 24-hour dietary recall, pre- and post-intervention.
  2. To compare consumption of fresh foods, sugar-sweetened foods and beverages pre- and post-intervention.

    The secondary objectives:

  3. To compare the weight-for-age z-scores of children pre- and post-intervention.
  4. To compare the height-for-age z-scores of children pre- and post-intervention.
  5. To compare the prevalence of malnutrition: underweight, stunting and wasting pre- and post-intervention.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • 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

    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
        • Universiti 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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • children aged under 5 years enrolled at PPR Lembah Subang 1 or
  • children aged under 5 years enrolled at the Child Health Clinic, Universiti Malaya Medical Center

Exclusion Criteria:

  • Children with low birth weight (<2.5 kg)
  • Children born pre-term (<37 weeks gestation) and
  • Children with chronic illnesses or severe malnutrition.

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
Intervention / Treatment
Active Comparator: Community
Regular food supplementation.
Supplementation of fresh foods
No Intervention: Child Health Clinic
No food supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum Dietary diversity score
Time Frame: Pre and post intervention, at least 4 months interval
The percentage of children who achieved the minimum dietary diversity score of 5 food groups, based on WHO 8 food groups and 24-hour dietary recall.
Pre and post intervention, at least 4 months interval
Consumption of healthy foods
Time Frame: Pre and post intervention, at least 4 months interval
The percentage of children who consume fresh fruits and/or vegetables pre- and post-intervention.
Pre and post intervention, at least 4 months interval
Consumption of unhealthy foods
Time Frame: Pre and post intervention, at least 4 months interval
The percentage of children who consume sugar-sweetened foods or beverages.
Pre and post intervention, at least 4 months interval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child's weight z-scores
Time Frame: Pre and post intervention, at least 4 months interval
Weight is measured in kilograms Weight will be adjusted for age and sex, i.e., Weight for age Z-score
Pre and post intervention, at least 4 months interval
Child's Height z-scores
Time Frame: Pre and post intervention, at least 4 months interval
Height is measured centimeters, adjusted for age and sex: Height-for-age Z-score
Pre and post intervention, at least 4 months interval

Collaborators and Investigators

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

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.

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)

July 4, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD used in results publication

IPD Sharing Time Frame

December 2025 to November 2026

IPD Sharing Access Criteria

To request for access from the PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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