- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07583667
Nutrition Intervention Among Ethnic Minority Children Aged 5-16 Years in Tra Vinh Province, Vietnam
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:
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tra Vinh
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Thanh pho Tra Vinh, Tra Vinh, Vietnam
- Community Health Centers in Tra Vinh Province
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Ethnic minority children aged 5-16 years
- Living in selected communities or attending selected schools
- Consent from parents/caregivers and assent from children
Exclusion Criteria:
- Congenital deformities affecting anthropometry
- Medical conditions affecting body composition measurement
- Inability to participate in interviews
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: intervention group
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.
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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.
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Sin intervención: control group
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in BMI-for-age z-score
Periodo de tiempo: Baseline and 6 months
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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.
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Baseline and 6 months
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Change in prevalence of malnutrition (including undernutrition and overweight/obesity)
Periodo de tiempo: Baseline and 6 months
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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.
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Baseline and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in nutrition-related knowledge, attitudes, and practices (KAP)
Periodo de tiempo: Baseline and 6 months
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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. |
Baseline and 6 months
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Change in diet quality scores
Periodo de tiempo: Baseline and 6 months
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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. |
Baseline and 6 months
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Change in physical activity levels
Periodo de tiempo: Baseline and 6 months
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Physical activity levels assessed using a standardized questionnaire, including frequency and duration of moderate-to-vigorous physical activity.
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Baseline and 6 months
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Change in skeletal muscle mass
Periodo de tiempo: Baseline and 6 months
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Skeletal muscle mass (SMM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
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Baseline and 6 months
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Change in body fat mass
Periodo de tiempo: Baseline and 6 months
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Body fat mass (BFM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
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Baseline and 6 months
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Change in fat-free mass
Periodo de tiempo: Baseline and 6 months
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Fat-free mass (FFM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
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Baseline and 6 months
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Truc T Thanh, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB No. 493/HDDD-DHYD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
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