- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01882335
Saving Brain in Uganda and Burkina Faso
Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Kampala, Ouganda
- Makerere University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
- Informed caregiver consent
Exclusion Criteria:
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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Aucune intervention: Control
No peer support for exclusive breastfeeding
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive function
Délai: one year
|
Proportion of children with impaired cognitive function in intervention compared to the control group
|
one year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
School attainment
Délai: One year
|
School attainment in the intervention compared to school attainment in the control group
|
One year
|
|
School readiness
Délai: One year
|
The age at which children are ready to start school in the intervention compared to the control group.
|
One year
|
|
Physical growth
Délai: One year
|
Compare the proportion of children with poor nutritional status in the intervention and control group.
|
One year
|
|
Behavioural and emotional status
Délai: One year
|
Behavioral and emotional status of children in the intervention compared to those in the control group
|
One year
|
|
Household economic status
Délai: One year
|
Assess the social economic status in the intervention compared to the social economic status in the control group.
|
One year
|
|
Motor skills
Délai: One year
|
Compare motor skills of children in the intervention compared to the control group using MABC
|
One year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: James K Tumwine, PhD, Makerere University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Grant # 0064-03 (Autre identifiant: GRAND CHALLENGES CANADA)
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