- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02516852
Assessing the Effect of Sustainable Small-scale Egg Production on Maternal and Child Nutrition in Rural Zambia
Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth and development. Yet, for poor children in developing countries, ASF consumption is limited by cost, inadequate caregiver knowledge, and lack of local production and physical availability. The impact of HH- and village-level livestock interventions on household dietary diversity and nutritional status in resource-poor communities is not well established. The objective of this study is to test the effectiveness of local egg production intervention on maternal and child diets and child nutrition status.
This project takes place in the Luangwa Valley, Zambia in partnership with a local non-governmental organization, COMACO. Twenty communities will be assigned to the intervention, and 20 matched communities will be selected as controls. In each intervention community, an egg production facility will be built, owned, and operated by trained COMACO farmers.
Households (HHs) in each community will be sampled twice annually for 1 year pre-intervention (baseline) and 1 year post-intervention to assess dietary diversity and nutritional status. Data analysis will test for a change in these outcomes from baseline in each intervention community compared to the matched control community.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objective of this study is to test the effectiveness of an intervention establishing local egg production on maternal and child diets and nutrition status. The investigators hypothesize that this intervention, combined with appropriate agricultural extension and nutrition education programs, will result in: 1) increased total household, maternal, and child consumption of eggs; 2) improved maternal and child dietary quality; and 3) improved infant/ young child nutritional status.
The investigators will test this hypothesis in the Luangwa Valley, Zambia in partnership with a local non-governmental organization, Community Markets for Conservation (COMACO). The forty study sites are located in four geographic clusters (Chiefdoms) in Eastern Province Zambia. These Chiefdoms are located in two districts: Mambwe (Mnkhanya, Jumbe, and Nsefu Chiefdoms) and Lundazi (Mwanya Chiefdom).
Twenty communities will be assigned to the intervention (egg production), and 20 matched communities will be selected as controls (no intervention). In each intervention community, an egg production facility will be built, each owned and operated by trained COMACO farmers, mostly women. Each group will be provided layer pullets at point-of-lay and layer mash. Facility owners will make all business decisions, retain all profits, and will be responsible for all upkeep costs.
In a repeated cross-sectional study design, indicators of food security, wealth, diet, nutritional status (anthropometrics), and health and wellbeing will be assessed in all egg-producing HHs and in women/child dyads (children aged 6-36 months) residing in the area surrounding each facility or central control point. Data will be collected twice annually for 1 year pre-intervention (baseline) and 1 year post-intervention.
The exposure of interest is living in an egg-producing community. In the primary analysis, the investigators will use hierarchical mixed effects modeling to analyze the effect of the program on each of the outcomes of interest (see Outcome Measures section for details).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
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Eastern Province
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Mfuwe, Eastern Province, Zambia
- COMACO
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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:
- the HH dwelling is ≤1.5 km from the egg production facility or central control point;
- there is a child 6-36 months of age in the HH; and,
Additionally, all HHs that include a member of the egg production group will be enrolled in the study, regardless of whether or not they meet the above inclusion criteria.
Exclusion Criteria:
- the mother/primary caretaker or head of HH cannot converse with the field staff because of language;
- the mother/primary caretaker or head of HH is unable to give informed consent or complete an interview without assistance; or,
- the child is deformed, disabled, severely ill, or unable to cooperate for anthropometric measures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervención
|
Establishment and support of a community-owned and -operated egg production facility located at a central location in the community
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Sin intervención: Control
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in child height-for-age Z-score
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
Recumbent length for children < 24 months and standing height for those 24-36 months, with WHO Child Growth Standards as the reference population.
|
6, 12, 18, and 24 months after intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in household egg consumption
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
7 day recall on total number of chicken or other eggs consumed in the household
|
6, 12, 18, and 24 months after intervention
|
Change in maternal egg consumption
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
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6, 12, 18, and 24 months after intervention
|
|
Change in child egg consumption
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
6, 12, 18, and 24 months after intervention
|
|
Change in maternal dietary diversity
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
Measured by Women's Dietary Diversity Score, a 24 hour recall of all foods consumed, organized into 9 food groups
|
6, 12, 18, and 24 months after intervention
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Change in child dietary diversity
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
6, 12, 18, and 24 months after intervention
|
|
Change in child stunting
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
Defined as having a height-for-age z-score < -2.0, with WHO Growth Standards as the reference population.
|
6, 12, 18, and 24 months after intervention
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in household food security
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
Measure by Household Food Insecurity Access Scale (HFIAS), Household Hunger Scale (HHS) and/or Months of inadequate household food provisioning (MIHFP)
|
6, 12, 18, and 24 months after intervention
|
Change in producer household and poultry incomes
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
6, 12, 18, and 24 months after intervention
|
|
Change in maternal physical and emotional health
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
Measured through a 6-item index adapted from RAND short form
|
6, 12, 18, and 24 months after intervention
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Change in maternal nutritional status
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
Measured by mid-upper arm circumference and body mass index
|
6, 12, 18, and 24 months after intervention
|
Change in child weight-for-height Z-score
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
6, 12, 18, and 24 months after intervention
|
|
Change in child weight-for-age Z-score
Periodo de tiempo: 6, 12, 18, and 24 months after intervention
|
6, 12, 18, and 24 months after intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alexander J Travis, VMD, PhD, Cornell University
Publicaciones y enlaces útiles
Enlaces Útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1402004456
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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