Dietary AssessmentNCT06921135
Nutrition of Urban-poor Children
A study testing supplementation, food in people with Dietary Assessment and Growth, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Dietary Assessment, Growth, Nutritional Assessment
- What is being tested?
- supplementation, food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteMalaysia
- Study dates
- 4 Jul 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children with low birth weight (<2.5 kg)
- Children born pre-term (<37 weeks gestation) and
- Children with chronic illnesses or severe malnutrition.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti of Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Dietary Assessment, Growth, Nutritional Assessment
- Being tested
- supplementation, food
- Keywords
- Dietary diversity, Food supplement, malnutrition in children, Healthy food choice, sugar sweetened beverages and food
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementation, foodDietary supplement
Supplementation of fresh foods
| Study group | Role | What they receive |
|---|---|---|
| Community | Active comparator | Regular food supplementation. Receives: Dietary Supplement: supplementation, food |
| Child Health Clinic | No intervention | No food supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre and post intervention, at least 4 months interval
Consumption of unhealthy foods
The percentage of children who consume sugar-sweetened foods or beverages.
Measured: Pre and post intervention, at least 4 months interval
Secondary outcomes (2)
Child's weight z-scores
Weight is measured in kilograms Weight will be adjusted for age and sex, i.e., Weight for age Z-score
Measured: Pre and post intervention, at least 4 months interval
Child's Height z-scores
Height is measured centimeters, adjusted for age and sex: Height-for-age Z-score
Measured: Pre and post intervention, at least 4 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start4 Jul 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary AssessmentStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a retrospective pre-post interventional study.
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921135
- Sponsor's protocol ID
- Version 1.0
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in results publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nutritional Intervention in Young Children in PPR Lembah Subang 1: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06921135
- Acronym / sponsor ID
- Version 1.0
- Conditions
- Dietary Assessment, Growth, Nutritional Assessment
- Keywords
- Dietary diversity, Food supplement, malnutrition in children, Healthy food choice, sugar sweetened beverages and food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a retrospective pre-post interventional study.
| Arm | Type | Receives |
|---|---|---|
| Community | Active comparator | Dietary Supplement: supplementation, foodRegular food supplementation. |
| Child Health Clinic | No intervention | –No food supplementation. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Children with low birth weight (<2.5 kg)
- Children born pre-term (<37 weeks gestation) and
- Children with chronic illnesses or severe malnutrition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplementation, foodSupplementation of fresh foods | Dietary supplement | Community |
Primary outcome
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.
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.
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.
2 secondary outcomes
Child's weight z-scores
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- The Role of Nutrition in Brain Development: The Golden Opportunity of the "First 1000 Days"Link provided by the sponsor.
- Advocacy for Improving Nutrition in the First 1000 Days to Support Childhood Development and Adult HealthLink provided by the sponsor.
- 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.Link provided by the sponsor.
- World Health Organization. Indicators for assessing infant and young child feeding practices Part 1: Definitions. Geneva: WHO; 2008.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD used in results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation, food in people with Dietary Assessment and Growth, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Dietary diversity score (time frame: Pre and post intervention, at least 4 months interval). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.