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

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

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

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.
320

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
    • 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

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

  • 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

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.
Active Comparator: Community
Regular food supplementation.
Dietary supplement: supplementation, food
Supplementation of fresh foods
No Intervention: Child Health Clinic
No food supplementation.

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
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

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
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.

Sponsor

Sponsor

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

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.

Helpful Links

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.
July 4, 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, 2023

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).
March 25, 2025

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.
April 7, 2025

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.
April 10, 2025

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.
April 10, 2025

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.
April 7, 2025

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.
April 1, 2025

More Information

Terms related to this study

Keywords

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.
  • Version 1.0

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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