- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01882335
Saving Brain in Uganda and Burkina Faso
Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Between 2006 and 2008 we carried out a cluster randomized study (PROMISE-EBF) to establish the effect of individual home based peer counselling on exclusive breast feeding (EBF). The results, published in the Lancet in 2011 were remarkable(Tylleskar T, et al). The PROMISE-EBF trial which compared mothers in the intervention arm that were offered at least 5 peer-visits promoting EBF to mothers in the control arm, that received the standard of care showed a doubling in the prevalence of EBF in the intervention arm. Community-based peer counsellors increased the EBF rate in Uganda and Burkina Faso from about 40% to 80%.
The current study will trace and re-enrol at least 70% of the children involved in the PROMISE-EBF study. These children are now aged between 5 and 7 years.
The primary objective of the current study is to evaluate the effect of peer-counselling for EBF in the first six months of life on human capital formation among children in Uganda and Burkina Faso.
This study will contribute to a crucial wider discussion on external validity regarding the relationship between EBF and intellectual performance and mental health. In the social area, this study will identify solutions to potential barriers that limit scale up for peer-counselling for EBF. From the business perspective, the study will identify the best business model for affordable, acceptable and cost effective ways of delivering peer counselling for EBF in Burkina Faso and Uganda. If this intervention is found effective, and is adopted, it could improve productivity in adulthood and work towards breaking the cycle of poverty.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Kampala, Uganda
- Makerere 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:
- Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
- Informed caregiver consent
Exclusion Criteria:
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Behavioral
Peer support for mothers to encourage them to exclusively breastfeed their babies for 6 months
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Pregnant women were identified and randomized to peer support for exclusive breastfeeding in clusters.
They were followed up for 6 months post delivery.
Otros nombres:
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Sin intervención: Control
No peer support for exclusive breastfeeding
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cognitive function
Periodo de tiempo: one year
|
Proportion of children with impaired cognitive function in intervention compared to the control group
|
one year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation
Periodo de tiempo: 3 months
|
Determine the cost of promoting peer counselling for exclusive breastfeeding in relation to the cost of attending to children with poor outcomes
|
3 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
School attainment
Periodo de tiempo: One year
|
School attainment in the intervention compared to school attainment in the control group
|
One year
|
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School readiness
Periodo de tiempo: One year
|
The age at which children are ready to start school in the intervention compared to the control group.
|
One year
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Physical growth
Periodo de tiempo: One year
|
Compare the proportion of children with poor nutritional status in the intervention and control group.
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One year
|
|
Behavioural and emotional status
Periodo de tiempo: One year
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Behavioral and emotional status of children in the intervention compared to those in the control group
|
One year
|
|
Household economic status
Periodo de tiempo: One year
|
Assess the social economic status in the intervention compared to the social economic status in the control group.
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One year
|
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Motor skills
Periodo de tiempo: One year
|
Compare motor skills of children in the intervention compared to the control group using MABC
|
One year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: James K Tumwine, PhD, Makerere University
Publicaciones y enlaces útiles
Publicaciones Generales
- Engebretsen IMS, Nalugya JS, Skylstad V, Ndeezi G, Akol A, Babirye JN, Nankabirwa V, Tumwine JK. "I feel good when I drink"-detecting childhood-onset alcohol abuse and dependence in a Ugandan community trial cohort. Child Adolesc Psychiatry Ment Health. 2020 Oct 24;14:42. doi: 10.1186/s13034-020-00349-z. eCollection 2020.
- Tumwine JK, Nankabirwa V, Diallo HA, Engebretsen IMS, Ndeezi G, Bangirana P, Sanou AS, Kashala-Abotnes E, Boivin M, Giordani B, Elgen IB, Holding P, Kakooza-Mwesige A, Skylstad V, Nalugya J, Tylleskar T, Meda N. Exclusive breastfeeding promotion and neuropsychological outcomes in 5-8 year old children from Uganda and Burkina Faso: Results from the PROMISE EBF cluster randomized trial. PLoS One. 2018 Feb 23;13(2):e0191001. doi: 10.1371/journal.pone.0191001. eCollection 2018.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
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
- Grant # 0064-03 (Otro identificador: GRAND CHALLENGES CANADA)
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