Viewing Study NCT06921135


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Study NCT ID: NCT06921135
Status: COMPLETED
Last Update Posted: 2025-04-10
First Post: 2025-03-25
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Nutrition of Urban-poor Children
Sponsor: University of Malaya
Organization:

Study Overview

Official Title: The Impact of Nutritional Intervention in Young Children in PPR Lembah Subang 1: A Retrospective Study
Status: COMPLETED
Status Verified Date: 2025-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: