Malnutrition in ChildrenNCT07583667
Nutrition Intervention Among Ethnic Minority Children Aged 5-16 Years in Tra Vinh Province, Vietnam
A study testing Nutrition Health Education in people with Malnutrition in Children and Undernutrition, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The goal of this study is to evaluate the effectiveness of a nutrition health education intervention among ethnic minority children aged 5-16 years in Tra Vinh Province, Vietnam. It will also assess factors associated with nutritional status in this population. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition in Children, Undernutrition, Overweight
- What is being tested?
- Nutrition Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 811 participants
- Where
- 1 siteVietnam
- Study dates
- 6 Nov 2024to 27 Apr 2025
- 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 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ethnic minority children aged 5-16 years
- Living in selected communities or attending selected schools
- Consent from parents/caregivers and assent from children
Who cannot join
- Congenital deformities affecting anthropometry
- Medical conditions affecting body composition measurement
- Inability to participate in interviews
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Community Health Centers in Tra Vinh Province
Thanh pho Tra Vinh, Tra Vinh
About this study
Official title: Nutritional Status, Associated Factors, and Preliminary Effectiveness of a Nutrition Health Education Intervention Among Ethnic Minority Children Aged 5-16 Years in Tra Vinh Province, Vietnam
The goal of this study is to evaluate the effectiveness of a nutrition health education intervention among ethnic minority children aged 5-16 years in Tra Vinh Province, Vietnam. It will also assess factors associated with nutritional status in this population.
The main questions it aims to answer are:
Read more
Does the nutrition health education intervention improve nutritional status? Does the intervention improve nutrition-related knowledge, attitudes, and practices (KAP)? Does the intervention improve diet quality and physical activity levels among participants?
Researchers will compare participants receiving the nutrition education intervention with control group to evaluate the effectiveness of the intervention.
Participants in intervention group will:
Participate in a structured nutrition education program delivered monthly for 4 months through interactive lessons, videos, and educational materials Receive ongoing support and reinforcement activities for an additional 2 months Attend baseline and follow-up assessments including anthropometric measurements and interviews Complete questionnaires on nutrition knowledge, dietary practices, and physical activity
- Conditions
- Malnutrition in Children, Undernutrition, Overweight, Obesity
- Being tested
- Nutrition Health Education
- Keywords
- Community-Based Intervention, Malnutrition, nutrition education, Ethnic Minority Children
- Medical subject headings
- Child Nutrition Disorders, Malnutrition, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Health EducationBehavioural
A multi-component nutrition health education program delivered through community-based and school-based models. For children aged 5-10 years, both children and their caregivers participate in nutrition education sessions at local health stations. For children aged 11-16 years, the intervention is delivered at ethnic minority boarding schools. The program consists of four monthly structured sessions using presentations and videos, supported by interactive posters, nutrition leaflets, and dietary and physical activity diaries. The key topics include: (1) nutrients and health, (2) prevention of undernutrition and overweight/obesity, (3) healthy dietary habits, and (4) physical activity promotion. The intervention lasts four months, followed by a two-month maintenance phase with reinforcement by community health workers, school staff, and family engagement.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants receive a structured nutrition health education intervention delivered through community-based and school-based models. The program includes four monthly educational sessions using presentations and videos, supported by interactive posters, nutrition leaflets, and dietary and physical activity diaries. The intervention is implemented over four months, followed by a two-month maintenance phase with reinforcement activities involving community health workers, school staff, and family engagement. Receives: Behavioral: Nutrition Health Education |
| control group | No intervention | Participants do not receive the structured nutrition education intervention. They continue to receive routine health and nutrition education activities available at local community health centers and schools without additional intervention from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI-for-age z-score
Weight and height will be combined to report BMI in kilogram/meters^2. BMI-for-age z-score calculated according to the 2007 WHO growth standards.
Measured: Baseline and 6 months
Change in prevalence of malnutrition (including undernutrition and overweight/obesity)
Proportion of participants with abnormal nutritional status, including undernutrition (stunting, underweight, or thinness) and overweight/obesity, classified according to WHO growth reference standards based on age- and sex-specific z-scores.
Measured: Baseline and 6 months
Secondary outcomes (6)
Change in nutrition-related knowledge, attitudes, and practices (KAP)
Nutrition knowledge, attitudes, and practices assessed using a structured questionnaire developed based on the Food and Agriculture Organization of the United Nations Guidelines for assessing nutrition-related knowledge, attitudes and practices.
Knowledge scores ranged from 0 to 11, attitude scores from 0 to 17, and practice scores from 0 to 8, with higher scores indicating better nutrition knowledge, more favorable nutrition attitudes, and better nutrition practices.
Measured: Baseline and 6 months
Change in diet quality scores
Diet quality was assessed using the Diet Quality Questionnaire (DQQ), including the Dietary Diversity Score (DDS) and the Global Dietary Recommendations (GDR) score.
The Dietary Diversity Score (DDS) ranges from 0 to 10 based on the number of food groups consumed, with higher scores indicating greater dietary diversity.
The Global Dietary Recommendations (GDR) score ranges from 0 to 18 and reflects adherence to global dietary recommendations for protection against non-communicable diseases, with higher scores indicating better adherence to recommended dietary patterns.
Measured: Baseline and 6 months
Change in physical activity levels
Physical activity levels assessed using a standardized questionnaire, including frequency and duration of moderate-to-vigorous physical activity.
Measured: Baseline and 6 months
Change in skeletal muscle mass
Skeletal muscle mass (SMM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
Measured: Baseline and 6 months
Change in body fat mass
Body fat mass (BFM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
Measured: Baseline and 6 months
Change in fat-free mass
Fat-free mass (FFM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start6 Nov 2024
- Primary completion27 Apr 2025
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malnutrition in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 811 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui Thi Hoang Lan, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Truc T Thanh, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583667
- Sponsor's protocol ID
- IRB No. 493/HDDD-DHYD
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data presented in this study are available on request from the corresponding author.
Publications
Dike IC, Ebizie EN, Chukwuone CA, Ejiofor NJ, Anowai CC, Ogbonnaya EK, Ugwu EI, Nkechinyere US, Chigbu EF, Ezeaku MN, Nnadi GC, Ihuoma EC, Gera NP, Chikwendu JN. Effect of community-based nutritional counseling intervention on children's eating habits. Medicine (Baltimore). 2021 Jul 30;100(30):e26563. doi: 10.1097/MD.0000000000026563.
PubMed 34397687Annan RA, Apprey C, Agyemang GO, Tuekpe DM, Asamoah-Boakye O, Okonogi S, Yamauchi T, Sakurai T. Nutrition education improves knowledge and BMI-for-age in Ghanaian school-aged children. Afr Health Sci. 2021 Jun;21(2):927-941. doi: 10.4314/ahs.v21i2.55.
PubMed 34795753Truong DTT, Tran THT, Nguyen TTT, Tran VHT. Double burden of malnutrition in ethnic minority school-aged children living in mountainous areas of Vietnam and its association with nutritional behavior. Nutr Res Pract. 2022 Oct;16(5):658-672. doi: 10.4162/nrp.2022.16.5.658. Epub 2022 Jan 25.
PubMed 36238380
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status, Associated Factors, and Preliminary Effectiveness of a Nutrition Health Education Intervention Among Ethnic Minority Children Aged 5-16 Years in Tra Vinh Province, Vietnam
- ClinicalTrials.gov ID
- NCT07583667
- Acronym / sponsor ID
- IRB No. 493/HDDD-DHYD
- Conditions
- Malnutrition in Children, Undernutrition, Overweight, Obesity
- Keywords
- Community-Based Intervention, Malnutrition, nutrition education, Ethnic Minority Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 27 Apr 2025 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 13 May 2026 (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 goal of this study is to evaluate the effectiveness of a nutrition health education intervention among ethnic minority children aged 5-16 years in Tra Vinh Province, Vietnam. It will also assess factors associated with nutritional status in this population.
The main questions it aims to answer are:
Does the nutrition health education intervention improve nutritional status? Does the intervention improve nutrition-related knowledge, attitudes, and practices (KAP)? Does the intervention improve diet quality and physical activity levels among participants?
Researchers will compare participants receiving the nutrition education intervention with control group to evaluate the effectiveness of the intervention.
Participants in intervention group will:
Participate in a structured nutrition education program delivered monthly for 4 months through interactive lessons, videos, and educational materials Receive ongoing support and reinforcement activities for an additional 2 months Attend baseline and follow-up assessments including anthropometric measurements and interviews Complete questionnaires on nutrition knowledge, dietary practices, and physical activity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Nutrition Health EducationParticipants receive a structured nutrition health education intervention delivered through community-based and school-based models. The program includes four monthly educational sessions using presentations and videos, supported by interactive posters, nutrition leaflets, and dietary and physical activity diaries. The intervention is implemented over four months, followed by a two-month maintenance phase with reinforcement activities involving community health workers, school staff, and family engagement. |
| control group | No intervention | –Participants do not receive the structured nutrition education intervention. They continue to receive routine health and nutrition education activities available at local community health centers and schools without additional intervention from the study. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ethnic minority children aged 5-16 years
- Living in selected communities or attending selected schools
- Consent from parents/caregivers and assent from children
Key exclusion criteria (3 listed)
- Congenital deformities affecting anthropometry
- Medical conditions affecting body composition measurement
- Inability to participate in interviews
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 |
|---|---|---|
| Nutrition Health EducationA multi-component nutrition health education program delivered through community-based and school-based models. For children aged 5-10 years, both children and their caregivers participate in nutrition education sessions at local health stations. For children aged 11-16 years, the intervention is delivered at ethnic minority boarding schools. The program consists of four monthly structured sessions using presentations and videos, supported by interactive posters, nutrition leaflets, and dietary and physical activity diaries. The key topics include: (1) nutrients and health, (2) prevention of undernutrition and overweight/obesity, (3) healthy dietary habits, and (4) physical activity promotion. The intervention lasts four months, followed by a two-month maintenance phase with reinforcement by community health workers, school staff, and family engagement. | Behavioural | intervention group |
Primary outcome
Change in BMI-for-age z-score
Time frame: Baseline and 6 months
Weight and height will be combined to report BMI in kilogram/meters^2. BMI-for-age z-score calculated according to the 2007 WHO growth standards.
Change in prevalence of malnutrition (including undernutrition and overweight/obesity)
Time frame: Baseline and 6 months
Proportion of participants with abnormal nutritional status, including undernutrition (stunting, underweight, or thinness) and overweight/obesity, classified according to WHO growth reference standards based on age- and sex-specific z-scores.
6 secondary outcomes
Change in nutrition-related knowledge, attitudes, and practices (KAP)
Time frame: Baseline and 6 months
Change in diet quality scores
Time frame: Baseline and 6 months
Change in physical activity levels
Time frame: Baseline and 6 months
Change in skeletal muscle mass
Time frame: Baseline and 6 months
Change in body fat mass
Time frame: Baseline and 6 months
Change in fat-free mass
Time frame: Baseline and 6 months
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 13 May 2026.
- Background: PubMed 34397687Dike IC, Ebizie EN, Chukwuone CA, Ejiofor NJ, Anowai CC, Ogbonnaya EK, Ugwu EI, Nkechinyere US, Chigbu EF, Ezeaku MN, Nnadi GC, Ihuoma EC, Gera NP, Chikwendu JN. Effect of community-based nutritional counseling intervention on children's eating habits. Medicine (Baltimore). 2021 Jul 30;100(30):e26563. doi: 10.1097/MD.0000000000026563.
- Background: PubMed 34795753Annan RA, Apprey C, Agyemang GO, Tuekpe DM, Asamoah-Boakye O, Okonogi S, Yamauchi T, Sakurai T. Nutrition education improves knowledge and BMI-for-age in Ghanaian school-aged children. Afr Health Sci. 2021 Jun;21(2):927-941. doi: 10.4314/ahs.v21i2.55.
- Background: PubMed 36238380Truong DTT, Tran THT, Nguyen TTT, Tran VHT. Double burden of malnutrition in ethnic minority school-aged children living in mountainous areas of Vietnam and its association with nutritional behavior. Nutr Res Pract. 2022 Oct;16(5):658-672. doi: 10.4162/nrp.2022.16.5.658. Epub 2022 Jan 25.
- EPIDEMIOLOGY OF NUTRITIONAL STATUS AMONG ETHNIC MINORITY CHILDRENAGED 5-16 YEARSIN THE CITY AND TWODISTRICTSOF TRA VINH PROVINCE, 2024Link provided by the sponsor.
- NUTRITION KNOWLEDGE AND NUTRITIONAL STATUSAMONG ETHNIC MINORITYCHILDREN IN TRA VINH PROVINCELink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data presented in this study are available on request from the corresponding author.
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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.
Truc T Thanh, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Health Education in people with Malnutrition in Children and Undernutrition, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 3 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 13 May 2026. 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 Vietnam. 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?
Change in BMI-for-age z-score (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07583667, which also lists 3 linked publications.
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 13 May 2026.