- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01882335
Saving Brain in Uganda and Burkina Faso
Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kampala, Uganda
- Makerere University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
- Informed caregiver consent
Exclusion Criteria:
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
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Ingen indgriben: Control
No peer support for exclusive breastfeeding
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cognitive function
Tidsramme: one year
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Proportion of children with impaired cognitive function in intervention compared to the control group
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one year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation
Tidsramme: 3 months
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Determine the cost of promoting peer counselling for exclusive breastfeeding in relation to the cost of attending to children with poor outcomes
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3 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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School attainment
Tidsramme: One year
|
School attainment in the intervention compared to school attainment in the control group
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One year
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School readiness
Tidsramme: One year
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The age at which children are ready to start school in the intervention compared to the control group.
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One year
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Physical growth
Tidsramme: One year
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Compare the proportion of children with poor nutritional status in the intervention and control group.
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One year
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Behavioural and emotional status
Tidsramme: One year
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Behavioral and emotional status of children in the intervention compared to those in the control group
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One year
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Household economic status
Tidsramme: One year
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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
Tidsramme: One year
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Compare motor skills of children in the intervention compared to the control group using MABC
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One year
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: James K Tumwine, PhD, Makerere University
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Grant # 0064-03 (Anden identifikator: GRAND CHALLENGES CANADA)
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Kliniske forsøg med Peer support for exclusive breastfeeding
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Northwestern UniversityAfsluttetDepressionForenede Stater
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Johns Hopkins UniversityPatient-Centered Outcomes Research InstituteAfsluttet
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Jinan University GuangzhouGuangzhou Sport UniversityAfsluttetForebyggelse af fedme | Depression - svær depressiv lidelse | Psykologisk velværeKina
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pınar doganAfsluttetKronisk nyresygdom, der kræver hæmodialyseKalkun
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MRC/UVRI and LSHTM Uganda Research UnitKarolinska Institutet; European and Developing Countries Clinical Trials... og andre samarbejdspartnereAfsluttet
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Ohio State UniversityCambia Health FoundationAfsluttetDemens | Familieplejer | Peer SupportForenede Stater
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University of AlbertaAlberta Health servicesAfsluttetDepression | Skizofreni | ManiodepressivCanada
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Johns Hopkins UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Ikke rekrutterer endnuAlkoholbrugsforstyrrelse | Levertransplantationsmodtager | Alkoholrelateret leversygdomForenede Stater
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