- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01882335
Saving Brain in Uganda and Burkina Faso
Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Kampala, Uganda
- Makerere University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
- Informed caregiver consent
Exclusion Criteria:
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Behavioral
Peer support for mothers to encourage them to exclusively breastfeed their babies for 6 months
|
Pregnant women were identified and randomized to peer support for exclusive breastfeeding in clusters.
They were followed up for 6 months post delivery.
Outros nomes:
|
|
Sem intervenção: Control
No peer support for exclusive breastfeeding
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cognitive function
Prazo: one year
|
Proportion of children with impaired cognitive function in intervention compared to the control group
|
one year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
School attainment
Prazo: One year
|
School attainment in the intervention compared to school attainment in the control group
|
One year
|
|
School readiness
Prazo: One year
|
The age at which children are ready to start school in the intervention compared to the control group.
|
One year
|
|
Physical growth
Prazo: One year
|
Compare the proportion of children with poor nutritional status in the intervention and control group.
|
One year
|
|
Behavioural and emotional status
Prazo: One year
|
Behavioral and emotional status of children in the intervention compared to those in the control group
|
One year
|
|
Household economic status
Prazo: One year
|
Assess the social economic status in the intervention compared to the social economic status in the control group.
|
One year
|
|
Motor skills
Prazo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Grant # 0064-03 (Outro identificador: GRAND CHALLENGES CANADA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .