- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866124
MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition (MAM'Out)
October 9, 2015 updated by: 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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
1278
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
Other Names:
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No Intervention: Comparison group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative incidence of child wasting
Time Frame: 3-monthly until 24 months after inclusion
|
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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cumulative incidence of the state of stunting
Time Frame: 3-monthly until 24 months after inclusion
|
3-monthly until 24 months after inclusion
|
|
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mean height-for-age Z-score
Time Frame: 3-monthly until 24 months after inclusion
|
3-monthly until 24 months after inclusion
|
|
|
mean weight-for-length Z-score
Time Frame: 3-monthly until 24 months after inclusion
|
3-monthly until 24 months after inclusion
|
|
|
mid-upper arm circumference (MUAC)
Time Frame: 3-monthly until 24 months after inclusion
|
3-monthly until 24 months after inclusion
|
|
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edema
Time Frame: 3-monthly until 24 months after inclusion
|
3-monthly until 24 months after inclusion
|
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Prevalence of diarrhea
Time Frame: 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
Time Frame: 3-monthly until 24 months after inclusion
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3-monthly until 24 months after inclusion
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|
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Reported measle
Time Frame: 3-monthly until 24 months after inclusion
|
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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patrick Kolsteren, MD, PhD, Universiteit Gent, Institute of Tropical Medicine of Antwerp (Belgium)
- Study Director: Myriam Ait Aissa, MSc, Action Contre la Faim
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
May 7, 2013
First Submitted That Met QC Criteria
May 27, 2013
First Posted (Estimate)
May 31, 2013
Study Record Updates
Last Update Posted (Estimate)
October 12, 2015
Last Update Submitted That Met QC Criteria
October 9, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACF0213
- 1U01GH000646-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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