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Assessing the Effect of Sustainable Small-scale Egg Production on Maternal and Child Nutrition in Rural Zambia

2 de febrero de 2018 actualizado por: Cornell University

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

Terminado

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

Intervencionista

Inscripción (Actual)

3546

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Eastern Province
      • Mfuwe, Eastern Province, Zambia
        • COMACO

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 meses a 3 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. the HH dwelling is ≤1.5 km from the egg production facility or central control point;
  2. 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:

  1. the mother/primary caretaker or head of HH cannot converse with the field staff because of language;
  2. the mother/primary caretaker or head of HH is unable to give informed consent or complete an interview without assistance; or,
  3. the child is deformed, disabled, severely ill, or unable to cooperate for anthropometric measures.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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
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
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
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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Alexander J Travis, VMD, PhD, Cornell University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2014

Finalización primaria (Actual)

1 de julio de 2016

Finalización del estudio (Actual)

1 de mayo de 2017

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2015

Primero enviado que cumplió con los criterios de control de calidad

4 de agosto de 2015

Publicado por primera vez (Estimar)

6 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de febrero de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

2 de febrero de 2018

Última verificación

1 de febrero de 2018

Más información

Términos relacionados con este estudio

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. .

Ensayos clínicos sobre Desnutrición, Niño

Ensayos clínicos sobre Egg production

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