- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01866124
MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition (MAM'Out)
9. oktober 2015 opdateret af: 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.
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1278
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 1 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 navne:
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Ingen indgriben: Sammenligningsgruppe
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Patrick Kolsteren, MD, PhD, Universiteit Gent, Institute of Tropical Medicine of Antwerp (Belgium)
- Studieleder: Myriam Ait Aissa, MSc, Action Contre la Faim
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2013
Primær færdiggørelse (Faktiske)
1. oktober 2015
Studieafslutning (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først indsendt
7. maj 2013
Først indsendt, der opfyldte QC-kriterier
27. maj 2013
Først opslået (Skøn)
31. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. oktober 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. oktober 2015
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACF0213
- 1U01GH000646-01 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Cash transfer
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University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Afsluttet
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The National Center on Addiction and Substance...Patient-Centered Outcomes Research InstituteAfsluttetADHD | StofbrugsforstyrrelserForenede Stater