Clinical trial NCT01866124: MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition
Official title: MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Malnutrition
Keywords: acute malnutrition
multiannual and seasonal cash transfers
safety nets
Burkina Faso
Lead sponsor: Action Contre la Faim
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: University Ghent
name: AgroParisTech
First posted: 2013-05-31
Enrollment: 1278
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of child wasting
timeFrame: 3-monthly until 24 months after inclusion
measure: Incremental cost-effectiveness ratio
timeFrame: 24 months after inclusion
Secondary outcomes:
measure: cumulative incidence of the state of stunting
timeFrame: 3-monthly until 24 months after inclusion
measure: mean height-for-age Z-score
timeFrame: 3-monthly until 24 months after inclusion
measure: mean weight-for-length Z-score
timeFrame: 3-monthly until 24 months after inclusion
measure: mid-upper arm circumference (MUAC)
timeFrame: 3-monthly until 24 months after inclusion
measure: edema
timeFrame: 3-monthly until 24 months after inclusion
measure: Prevalence of diarrhea
timeFrame: 3-monthly until 24 months after inclusion
measure: Prevalence of acute respiratory infections
timeFrame: 3-monthly until 24 months after inclusion
measure: Reported measle
timeFrame: 3-monthly until 24 months after inclusion
Other outcomes:
Locations:
city: Diapaga
country: Burkina Faso
facility: Action Contre la Faim - Burkina Faso
state: Tapoa
Study officials:
affiliation: Universiteit Gent, Institute of Tropical Medicine of Antwerp (Belgium)
name: Patrick Kolsteren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Action Contre la Faim
name: Myriam Ait Aissa, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.