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Completed

NCT Number: NCT06921135

Nutrition of Urban-poor Children

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.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti of Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

About this study

The primary objectives:

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

The secondary objectives:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

supplementation, food

Dietary Supplement

Supplementation of fresh foods

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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