- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06921135
Nutrition of Urban-poor Children
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:
- 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.
- 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.
- 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
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wilayah Persekutuan Kuala Lumpur
-
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
- Universiti of Malaya Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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
Sponsor
Publications and helpful links
Helpful Links
- The Role of Nutrition in Brain Development: The Golden Opportunity of the "First 1000 Days"
- Advocacy for Improving Nutrition in the First 1000 Days to Support Childhood Development and Adult Health
- Moursi, M., Arimond, M., Dewey, K., Trèche, S., Ruel, M., & Delpeuch, F. (2008). Dietary Diversity Is a Good Predictor of the Micronutrient Density of the Diet of 6- to 23-Month-Old Children in Madagascar.
- World Health Organization. Indicators for assessing infant and young child feeding practices Part 1: Definitions. Geneva: WHO; 2008.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Version 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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