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L4HLivestock Programming for Nutritional Improvements in Pregnant, Lactating Mothers and Children Under Five Years of Age in Marsabit County, Kenya

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Qué se está evaluando

Provision of livestock feeds

+ Nutrition counselling

Otro
Quiénes están siendo reclutados

Enfermedades Nutricionales y Metabólicas

+ Trastornos de la Nutrición

Entre 6 y 60 meses
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Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: septiembre de 2019
Ver detalles del protocolo

Resumen

Patrocinador PrincipalWashington State University
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 4 de septiembre de 2019

Fecha en la que se inscribió al primer participante.

Background: In households heavily dependent on livestock, declining availability of forage is associated with decreased consumption of animal source foods such as milk and meat, and consequently decline in child nutritional status. Populations living in Kenya's Arid and Semi-Arid Lands(ASALs) are predominantly pastoral, heavily dependent on livestock and practice seasonal mobility to access livestock pasture and water. Livestock interventions that maintain or improve health and productivity of animals have been postulated as important for reducing the risk of malnutrition during critical drought periods. Objectives: Here the investigators implement a cluster randomized control study trial to determine the effect of providing livestock feed, livestock feed and nutritional education and counselling during critical dry periods on household milk availability and consumption, and the risk of malnutrition in pregnant and lactating mothers, and children 5 years and below. Methods: A total of 1800 households owning livestock and with children 3 years and below in Marsabit County will be enrolled into three equal groups (arms) of 600 households each. Each household and participant will be followed for 18 months. Households in Arm 1 will receive livestock feed enough to maintain 2-3 milking animals during the critical dry period. Arm 2 will receive similar livestock feed and human nutritional education and counselling. Arm 3 (control arm) will not have any of the two interventions. Primary outcome measures will be child anthropometric indicators (height-for-age, weight-for-age and middle upper arm circumference) and maternal anthropometric measures (middle upper arm circumference, height, weight, weight-gain during pregnancy) collected quarterly. Data on a 24-hour recall of diet (number of meals taken, type/diversity of foods consumed including animal source foods, frequency of times and quantity of specific foods consumed) will be collected every 6 weeks. To control for additional factors that would influence nutritional status, the investigators will collect human health syndromic data (fever, diarrhoea, respiratory syndromes) and livestock health data every six weeks and socio-economic data quarterly including household demographics, incomes, expenditures, asset accumulation, gender roles, workload and time allocation. To control for exposure to infections such as brucellosis in humans and animals and for micronutrient and mycotoxin analysis, biological samples (venous blood of mother and child), animal biological samples (blood and milk) and household drinking water will be collected at recruitment, 6 months and at 12 months. The study will test the cost-effectiveness of livestock interventions and nutritional counselling in prevention of malnutrition and its health consequences, compared to treatment of malnutrition. Cost data associated with each study arm will be tracked to provide estimates of resources required to scale up for implementation. Results from this study will form the basis for monitoring efficiency and effectiveness of interventions aimed at reducing seasonal spikes in levels of acute malnutrition in children under five years and pregnant and lactating women in pastoralist communities. Study duration: Each study household and participant is followed for a period of 24 months from the time of enrolment into the study.

Título OficialLivestock Programming for Nutritional Improvements in Pregnant, Lactating Mothers and Children Under Five Years of Age in Marsabit County, Kenya
NCT04608656
Patrocinador PrincipalWashington State University
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 1734 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

Entre 6 y 60 meses

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades Nutricionales y MetabólicasTrastornos de la Nutrición

Criterios

Inclusion Criteria: * Household inclusion criteria Only households meeting the following study criteria will be recruited: * Presence of a mother (lactating or non-lactating) and child 3 years and below * Ownership of livestock with 1-6 tropical livestock units * Household consent to participate in the study o Including willingness to have 1-2 tropical livestock units (1-2 cattle or camel, 10-20 sheep/ goats) at household Exclusion Criteria: * Households excluded in the study will have the following criteria: * Households that do not consent to participate in the study * Households unwilling to adhere to the study protocol including feeding instructions and retaining the study animals at the household for milk access

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Households in villages assigned to intervention arm 1 will receive a pre-defined amount of feed to maintain two tropical livestock units for a total of 60 days during the dry season (when animals would be moved away in search of pastures).

Grupo II

Experimental
Households recruited into intervention arm two will receive livestock feeds similar to intervention arm 1 and will be enrolled in a nutritional education and counselling program through Infant and Young Child Nutrition (IYCF) feeding program and household food utilization. The IYCF program through the Baby Friendly Community Initiative (BFCI) will include the promotion of exclusive breastfeeding in the first six months, continued breastfeeding up to the age of two years, adequate complementary feeding, hygiene promotion and the uptake of child health services including immunization, treatment of illness, moderate and severe acute malnutrition and micro-nutrient supplementation.

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

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Suspendido

Washington State University

Nairobi, KenyaAbrir Washington State University en Google Maps
Completado1 Centros de Estudio