Clinical trial NCT06921135: Nutrition of Urban-poor Children
Official title: The Impact of Nutritional Intervention in Young Children in PPR Lembah Subang 1: A Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Assessment
Growth
Nutritional Assessment
Keywords: Dietary diversity
Food supplement
malnutrition in children
Healthy food choice
sugar sweetened beverages and food
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 320
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a retrospective pre-post interventional study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Minimum Dietary diversity score
timeFrame: Pre and post intervention, at least 4 months interval
measure: Consumption of healthy foods
timeFrame: Pre and post intervention, at least 4 months interval
measure: Consumption of unhealthy foods
timeFrame: Pre and post intervention, at least 4 months interval
Secondary outcomes:
measure: Child's weight z-scores
timeFrame: Pre and post intervention, at least 4 months interval
measure: Child's Height z-scores
timeFrame: Pre and post intervention, at least 4 months interval
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti of Malaya Medical Center
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References: