NCT07583667

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
811

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 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

November 6, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 1, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Community-Based InterventionMalnutritionnutrition educationEthnic Minority Children

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 6 months

Secondary Outcomes (6)

  • Change in nutrition-related knowledge, attitudes, and practices (KAP)

    Baseline and 6 months

  • Change in diet quality scores

    Baseline and 6 months

  • Change in physical activity levels

    Baseline and 6 months

  • Change in skeletal muscle mass

    Baseline and 6 months

  • Change in body fat mass

    Baseline and 6 months

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

intervention group

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ethnic minority children aged 5-16 years
  • Living in selected communities or attending selected schools
  • Consent from parents/caregivers and assent from children

You may not qualify if:

  • Congenital deformities affecting anthropometry
  • Medical conditions affecting body composition measurement
  • Inability to participate in interviews

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Health Centers in Tra Vinh Province

Thanh pho Tra Vinh, Tra Vinh, Vietnam

Location

Related Publications (3)

  • 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.

    PMID: 34397687BACKGROUND
  • Annan 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.

    PMID: 34795753BACKGROUND
  • Truong 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.

    PMID: 36238380BACKGROUND

Related Links

MeSH Terms

Conditions

Child Nutrition DisordersMalnutritionOverweightObesity

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Truc T Thanh, PhD

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 13, 2026

Study Start

November 6, 2024

Primary Completion

April 27, 2025

Study Completion

April 27, 2025

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The data presented in this study are available on request from the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
De-identified individual participant data and supporting documents will be available beginning 6 months after publication and ending 5 years after publication.
Access Criteria
De-identified individual participant data and supporting documents will be available upon reasonable request to the corresponding author for academic research purposes.

Locations