- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01866124
MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition (MAM'Out)
9. oktober 2015 oppdatert av: Action Contre la Faim
The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer program in the framework of a safety net to prevent acute malnutrition by children under 24 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region of Burkina Faso, Africa).
The program will be targeted to economically vulnerable households with children less than 1 year old at the time of inclusion and the cash distributed to mothers.
The transfers will be assimilated to unconditional ones, leading to beneficiaries' self-determination on the use that will be made of cash.
This study will be designed as a two-arm cluster randomized intervention trial, based on randomization of rural villages of the Tapoa province.
One arm will receive the intervention and one will be a control arm.
The main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the cost-effectiveness.
Anthropometric measures (height, weight and MUAC) will be measured, as well as indicators of dietary diversity, food security, health center frequentation, families' expenses and morbidities.
Questionnaires and 24-hour food recalls will also be analyzed.
Finally, based on a model theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed.
Studieoversikt
Detaljert beskrivelse
At international level, the WHO formulated guidelines for the treatment of severe acute malnutrition (or wasting) (WHO 1999, and more recently ACF 2011), and guidelines for moderate acute malnutrition (or wasting) are in the process of formulation.
In contrast, surprisingly little is known on preventive schemes for acute malnutrition.
In Haiti, Ruel et al (2008) found that targeting nutrition interventions to prevent children from becoming malnourished might be more effective than curative treatment to reduce child wasting.
In addition, recent preventive trials in humanitarian settings focused on the use of food-based strategies, especially ready-to-use food (Isanaka, 2009; Hendricks, 2010; Parikh, 2010; Imbad, 2011; Huybregts, 2012).
However, it is well known that the causes of under-nutrition are numerous and also relate to inadequate health and care practices, lack of food diversification, food insecurity… Therefore, the MAM'Out research project aims at assessing a context-adapted preventive approach, which is likely to influence several underlying causes of under-nutrition and not based primarily on food supplementation.
The objective is to provide an evidence base for this alternative approach, in order that proven intervention be taken into account for scale-up at policy-making levels.
Studietype
Intervensjonell
Registrering (Faktiske)
1278
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tapoa
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Diapaga, Tapoa, Burkina Faso, BP 105
- Action Contre la Faim - Burkina Faso
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 1 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Poor or very poor household (HEA criteria)
- Having at least one children under 1 year old at the time of inclusion
Exclusion Criteria:
- Medium or rich economic status (HEA criteria)
- no child under one year old at the time of inclusion
- not living in one of the 32 selected villages in the Tapoa province
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Cash transfer
Mothers are the primary recipient of the CT. The proposed approach will be based on monthly seasonal CTs during 5 months, from May to September, for two years (2013 and 2014). A monthly 10 000 FCFA will be transferred to the selected households. These CTs will be done via mobile phones, in collaboration with the mobile phone company Airtel. |
Recipient of transfers Mothers are the primary recipient of the CT.
Cash is transferred using mobile phone credits that can be cashed at specific cash points provided by a telecom company.
Andre navn:
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Ingen inngripen: Sammenligningsgruppe
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cumulative incidence of child wasting
Tidsramme: 3-monthly until 24 months after inclusion
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Record of the child's height, weight to compute Weight for Height Z-scores (WHZ scores) (wasting defined as WHZ<-2 or Edema)
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3-monthly until 24 months after inclusion
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Incremental cost-effectiveness ratio
Tidsramme: 24 months after inclusion
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Calculation of a cost-effectiveness ratio at the end of the study
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24 months after inclusion
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
cumulative incidence of the state of stunting
Tidsramme: 3-monthly until 24 months after inclusion
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3-monthly until 24 months after inclusion
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mean height-for-age Z-score
Tidsramme: 3-monthly until 24 months after inclusion
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3-monthly until 24 months after inclusion
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mean weight-for-length Z-score
Tidsramme: 3-monthly until 24 months after inclusion
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3-monthly until 24 months after inclusion
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mid-upper arm circumference (MUAC)
Tidsramme: 3-monthly until 24 months after inclusion
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3-monthly until 24 months after inclusion
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edema
Tidsramme: 3-monthly until 24 months after inclusion
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3-monthly until 24 months after inclusion
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Prevalence of diarrhea
Tidsramme: 3-monthly until 24 months after inclusion
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3-monthly until 24 months after inclusion
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Prevalence of acute respiratory infections
Tidsramme: 3-monthly until 24 months after inclusion
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3-monthly until 24 months after inclusion
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Reported measle
Tidsramme: 3-monthly until 24 months after inclusion
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the symptoms used to detect measles will be the following ones (from WHO) : tiny white spots on the inside of the mouth and rash on the face and/or the body
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3-monthly until 24 months after inclusion
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Patrick Kolsteren, MD, PhD, Universiteit Gent, Institute of Tropical Medicine of Antwerp (Belgium)
- Studieleder: Myriam Ait Aissa, MSc, Action Contre la Faim
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Tonguet-Papucci A, Houngbe F, Huybregts L, Ait-Aissa M, Altare C, Kolsteren P, Huneau JF. Unconditional Seasonal Cash Transfer Increases Intake of High-Nutritional-Value Foods in Young Burkinabe Children: Results of 24-Hour Dietary Recall Surveys within the Moderate Acute Malnutrition Out (MAM'Out) Randomized Controlled Trial. J Nutr. 2017 Jul;147(7):1418-1425. doi: 10.3945/jn.116.244517. Epub 2017 May 31.
- Tonguet-Papucci A, Houngbe F, Lompo P, Yameogo WME, Huneau JF, Ait Aissa M, Kolsteren P. Beneficiaries' perceptions and reported use of unconditional cash transfers intended to prevent acute malnutrition in children in poor rural communities in Burkina Faso: qualitative results from the MAM'Out randomized controlled trial. BMC Public Health. 2017 May 30;17(1):527. doi: 10.1186/s12889-017-4453-y.
- Houngbe F, Tonguet-Papucci A, Altare C, Ait-Aissa M, Huneau JF, Huybregts L, Kolsteren P. Unconditional Cash Transfers Do Not Prevent Children's Undernutrition in the Moderate Acute Malnutrition Out (MAM'Out) Cluster-Randomized Controlled Trial in Rural Burkina Faso. J Nutr. 2017 Jul;147(7):1410-1417. doi: 10.3945/jn.117.247858. Epub 2017 May 24.
- Tonguet-Papucci A, Huybregts L, Ait Aissa M, Huneau JF, Kolsteren P. The MAM'Out project: a randomized controlled trial to assess multiannual and seasonal cash transfers for the prevention of acute malnutrition in children under 36 months in Burkina Faso. BMC Public Health. 2015 Aug 8;15:762. doi: 10.1186/s12889-015-2060-3.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2013
Primær fullføring (Faktiske)
1. oktober 2015
Studiet fullført (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først innsendt
7. mai 2013
Først innsendt som oppfylte QC-kriteriene
27. mai 2013
Først lagt ut (Anslag)
31. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. oktober 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. oktober 2015
Sist bekreftet
1. oktober 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACF0213
- 1U01GH000646-01 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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