NCT06921135

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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

3.5 years

First QC Date

March 25, 2025

Last Update Submit

April 7, 2025

Conditions

Dietary AssessmentGrowthNutritional Assessment

Keywords

Dietary diversityFood supplementmalnutrition in childrenHealthy food choicesugar sweetened beverages and food

Outcome Measures

Primary Outcomes (3)

  • Minimum Dietary diversity score

    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

    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

    The percentage of children who consume sugar-sweetened foods or beverages.

    Pre and post intervention, at least 4 months interval

Secondary Outcomes (2)

  • Child's weight z-scores

    Pre and post intervention, at least 4 months interval

  • Child's Height z-scores

    Pre and post intervention, at least 4 months interval

Study Arms (2)

Community

ACTIVE COMPARATOR

Regular food supplementation.

Dietary Supplement: supplementation, food

Child Health Clinic

NO INTERVENTION

No food supplementation.

Interventions

supplementation, foodDIETARY_SUPPLEMENT

Supplementation of fresh foods

Community

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti of Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Links

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Dietary SupplementsFood

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study will be a retrospective pre-post interventional study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 10, 2025

Study Start

July 4, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

IPD used in results publication

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
December 2025 to November 2026
Access Criteria
To request for access from the PI
More information

Locations

MY(1)