An interventional study of Family Medicine-Oriented Nutrition Education and Counseling in Malnutrition and Child Nutrition Disorders, sponsored by Thai Nguyen University of Medicine and Pharmacy. Completed at 2 sites in Vietnam. Open to participants aged 0 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Thai Nguyen University of Medicine and Pharmacy · Not applicable, Interventional, and Prevention
This study aimed to assess the nutritional status of children under five years of age, identify factors associated with malnutrition, and evaluate the effects of a community-based nutrition intervention guided by family medicine principles in two communes of Bac Me District, Ha Giang Province, Vietnam.
The study employed a non-randomized controlled community intervention design. Yen Cuong commune was assigned to the intervention group, while Phieng Luong commune served as the comparison group.
The intervention included maternal nutrition education, individualized counseling, practical feeding demonstrations, growth monitoring, home visits, and coordinated family- and community-oriented care. The comparison group continued to receive routine child healthcare and nutrition services.
Assessments were conducted at baseline and approximately 6, 12, and 15 months after the start of the intervention. The study evaluated maternal nutrition knowledge and feeding practices, dietary intake, childhood illnesses, anthropometric indicators, and nutritional status.
The study was conducted from July 2024 to November 2025 and was completed before its retrospective registration on ClinicalTrials.gov.
**Study Design and Setting**
This community-based study combined a baseline cross-sectional assessment with a non-randomized controlled intervention. It was conducted in Yen Cuong and Phieng Luong communes, Bac Me District, Ha Giang Province, northern Vietnam, between July 2024 and November 2025.
The two communes were purposively selected. Yen Cuong was designated as the intervention group, while Phieng Luong served as the comparison group. Allocation was performed at the commune level without randomization. Each study arm comprised one commune.
**Intervention**
The intervention was designed around six principles of family medicine: continuity of care, comprehensive care, coordinated care, preventive care, family-oriented care, and community-oriented care.
The intervention package included:
The enhanced intervention was implemented for approximately 12 months. Families in the comparison commune continued receiving routine child health and nutrition services without the additional intervention package.
**Follow-up and Assessment**
Participants were evaluated at four time points: baseline (T0), approximately 6 months (T1), 12 months (T2), and 15 months (T3). The final assessment was conducted approximately three months after the end of the enhanced intervention to examine the maintenance of changes.
Study assessments included maternal nutrition knowledge, child feeding practices, 24-hour dietary intake, food diversity, common childhood illnesses, anthropometric measurements, and nutritional status classified according to WHO growth standards.
**Data Analysis**
The study assessed changes in outcomes over time within each commune and compared the observed changes between the two groups. Because allocation was non-randomized and each study arm contained only one commune, differences between groups could not be fully separated from commune-specific characteristics. Findings were therefore interpreted with appropriate caution regarding causal inference.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's enrollment of 976 is above the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →This is the only study on the registry with Thai Nguyen University of Medicine and Pharmacy as lead sponsor.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and their mothers or primary caregivers in Yen Cuong commune received an enhanced community-based nutrition intervention guided by family medicine principles. The intervention included nutrition education, individualized feeding counseling, practical meal preparation demonstrations, regular growth monitoring, home visits for children at nutritional risk, and coordinated family- and community-oriented support. The enhanced intervention lasted approximately 12 months, followed by a three-month maintenance assessment.
Behavioral: Family Medicine-Oriented Nutrition Education and Counseling
Children and their mothers or primary caregivers in Phieng Luong commune continued to receive routine child health and nutrition services through the existing primary healthcare system, including growth monitoring, routine nutritional counseling, immunization, vitamin A supplementation, and age-appropriate deworming. No additional family medicine-oriented nutrition intervention package was administered by the study.
A 12-month community-based behavioral nutrition intervention incorporating six family medicine principles: continuity, comprehensiveness, coordination, prevention, family orientation, and community orientation. Activities included structured nutrition education, individualized counseling, demonstrations of age-appropriate feeding using locally available foods, periodic anthropometric monitoring, home visits for children at nutritional risk, and caregiver support through commune and village health workers. Assessments were conducted at baseline and approximately 6, 12, and 15 months
Change in the Prevalence of Overall Undernutrition
The proportion of children with at least one form of undernutrition, defined as underweight (weight-for-age Z-score below -2), stunting (height-for-age Z-score below -2), or wasting (weight-for-height Z-score below -2), according to WHO growth standards. Changes are assessed within each study group and compared between the intervention and control groups.
Time frame: Baseline and Month 12
Proportion of Mothers With Adequate Nutrition Knowledge
Nutrition knowledge was assessed using a 25-item questionnaire. A score of at least 20 out of 25 was classified as adequate knowledge. The outcome was expressed as the percentage of mothers meeting this criterion at each assessment.
Time frame: Baseline, Month 6, Month 12, and Month 15
Prevalence of Stunting Among Children
Stunting was defined as a height-for-age Z-score below -2 standard deviations according to WHO growth standards. The outcome was measured as the percentage of children classified as stunted at each assessment.
Time frame: Baseline, Month 6, Month 12, and Month 15
Prevalence of Underweight Among Children
Underweight was defined as a weight-for-age Z-score below -2 standard deviations according to WHO growth standards. The outcome was measured as the percentage of children classified as underweight at each assessment.
Time frame: Baseline, Month 6, Month 12, and Month 15
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2024 to primary completion in Nov 2025, 16 months.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 16 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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