- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02098031
Improving the Nutrition Status of Infants in South-Western Uganda
Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda
Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development.
This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months.
A follow-up study is planned for the period January 2019 - December 2022.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kampala, Uganda
- Kyambogo University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- A lead caretaker with a 6-8 months infant (child/lead caretaker pair) who will have given consent to participate in the study. If there is more than one child of the age in the household, the younger one will be taken as the index/study child.
Exclusion Criteria:
- Is older than 8 months at baseline
- Congenital malformations or physical handicap that may influence growth or interfere with taking of anthropometric measurements
- Disability that will influence nutrient intake
- Been diagnosed with mental or brain illness as evidenced by mother or health worker.
- If the family that is likely to emigrate during the study period
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 |
---|---|
Sin intervención: control
|
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Experimental: intervention
Nutritional intervention (nutrition education)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)
Periodo de tiempo: 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years
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The investigators will measure the change in stunting between the three indicated time points.
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6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in mean weight-for-age z-score
Periodo de tiempo: 6-8, 12-16 and 20-24, 36 months, 7-10 years
|
The investigators will measure the change in mean weight for age z-score between the three indicated time periods.
|
6-8, 12-16 and 20-24, 36 months, 7-10 years
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Change in mean weight-for-height z-score
Periodo de tiempo: 6-8, 12-16, 20-24, 36 months, 7-10 years
|
The investigators will measure the change in mean weight for height z-score between the three indicated time periods.
|
6-8, 12-16, 20-24, 36 months, 7-10 years
|
Change in mean Mid Upper Arm Circumference (MUAC) z-score
Periodo de tiempo: 6-8, 12-16, 20-24, 36 months, 7-10 years
|
The investigators will measure the change in MUAC between the three indicated time periods.
|
6-8, 12-16, 20-24, 36 months, 7-10 years
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Change in mean diet diversification score (DDS)
Periodo de tiempo: 6-8, 12-16, 20-24, 36 months
|
The investigators will measure the change in DDS between the three indicated time periods.
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6-8, 12-16, 20-24, 36 months
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Change in Ages and Stages Questionnaire Scores (AQS)
Periodo de tiempo: 6-8, 12-16, 20-24, 36 months
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The investigators will measure the change in AQS between the three indicated time periods.
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6-8, 12-16, 20-24, 36 months
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Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)
Periodo de tiempo: 7-10 years
|
The investigators will measure the change in the scores of these tests at indicated time periods.
|
7-10 years
|
Change in Bayley Child Development test 3 ed.
Periodo de tiempo: 6-8, 12-16, 20-24, 36 months
|
The investigators will measure the change in Bayley Child Development test 3 ed.
between the three indicated time periods.
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6-8, 12-16, 20-24, 36 months
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Change in gut microbiota
Periodo de tiempo: 20-24, 36 months, 7-10 years
|
Fecal samples will be collected and the investigators will measure the change in gut microbiota between the three indicated time periods.
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20-24, 36 months, 7-10 years
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Change in oral microbiota
Periodo de tiempo: 36 months, 7-10 years
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Saliva samples will be collected and the investigators will measure the change in oral microbiota at indicated time periods.
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36 months, 7-10 years
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Change in Mullens test
Periodo de tiempo: 36 months
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The investigators will measure the change in Mullens test between the two groups after 36 months.
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36 months
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Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms
Periodo de tiempo: 7-10 years
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The investigators will measure the change in this test between the two groups at indicated time periods
|
7-10 years
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Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms
Periodo de tiempo: 7-10 years
|
The investigators will measure the change in this test between the two groups at indicated time periods
|
7-10 years
|
Oral health
Periodo de tiempo: 7-10 years
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The investigators will assay caries using photographs
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7-10 years
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Atukunda P, Ngari M, Chen X, Westerberg AC, Iversen PO, Muhoozi G. Longitudinal assessments of child growth: A six-year follow-up of a cluster-randomized maternal education trial. Clin Nutr. 2021 Sep;40(9):5106-5113. doi: 10.1016/j.clnu.2021.08.007. Epub 2021 Aug 20.
- Kakwangire P, Moss C, Matovu N, Atukunda P, Westerberg AC, Iversen PO, Muhoozi G. The association between dietary diversity and development among children under 24 months in rural Uganda: analysis of a cluster-randomised maternal education trial. Public Health Nutr. 2021 Sep;24(13):4286-4296. doi: 10.1017/S136898002100077X. Epub 2021 Mar 12.
- Atukunda P, Muhoozi GK, Diep LM, Berg JP, Westerberg AC, Iversen PO. The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial. Public Health Nutr. 2021 Aug;24(12):3730-3739. doi: 10.1017/S1368980020001603. Epub 2020 Jul 13.
- Atukunda P, Muhoozi GKM, van den Broek TJ, Kort R, Diep LM, Kaaya AN, Iversen PO, Westerberg AC. Child development, growth and microbiota: follow-up of a randomized education trial in Uganda. J Glob Health. 2019 Jun;9(1):010431. doi: 10.7189/jogh.09.010431.
- Muhoozi GKM, Atukunda P, Diep LM, Mwadime R, Kaaya AN, Skaare AB, Willumsen T, Westerberg AC, Iversen PO. Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development among infants in Uganda: A cluster-randomized trial. Matern Child Nutr. 2018 Apr;14(2):e12527. doi: 10.1111/mcn.12527. Epub 2017 Sep 19.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 100
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