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Acute MalnutritionMAM'OutNCT01866124

MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition

A study testing Cash transfer in people with Acute Malnutrition, run by Action Contre la Faim at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages Up to 12 months
Conditions the study is for
Acute Malnutrition
What is being tested?
Cash transfer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,278 participants
Where
1 siteBurkina Faso
Study dates
May 2013to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Poor or very poor household (HEA criteria)
  • Having at least one children under 1 year old at the time of inclusion

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

  • Action Contre la Faim - Burkina Faso

    Diapaga, Tapoa, BP 105

Other trials in Burkina Faso

About this study

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.

Read the 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.

Being tested
Cash transfer
Keywords
acute malnutrition, multiannual and seasonal cash transfers, safety nets, Burkina Faso

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cash transferOther

    Also called Multiannual and seasonal cash transfer

    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.

Study groups in NCT01866124
Study groupRoleWhat they receive
Cash transferExperimentalMothers 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.
Receives: Other: Cash transfer
Comparison groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of child wasting

    Record of the child's height, weight to compute Weight for Height Z-scores (WHZ scores) (wasting defined as WHZ<-2 or Edema)

    Measured: 3-monthly until 24 months after inclusion

  2. Incremental cost-effectiveness ratio

    Calculation of a cost-effectiveness ratio at the end of the study

    Measured: 24 months after inclusion

Secondary outcomes (8)

  1. cumulative incidence of the state of stunting

    Measured: 3-monthly until 24 months after inclusion

  2. mean height-for-age Z-score

    Measured: 3-monthly until 24 months after inclusion

  3. mean weight-for-length Z-score

    Measured: 3-monthly until 24 months after inclusion

  4. mid-upper arm circumference (MUAC)

    Measured: 3-monthly until 24 months after inclusion

  5. edema

    Measured: 3-monthly until 24 months after inclusion

  6. Prevalence of diarrhea

    Measured: 3-monthly until 24 months after inclusion

  7. Prevalence of acute respiratory infections

    Measured: 3-monthly until 24 months after inclusion

  8. Reported measle

    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

    Measured: 3-monthly until 24 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01866124
Sponsor's protocol ID
ACF0213
Other IDs
1U01GH000646-01
Acronym
MAM'Out
Status last verified
Oct 2015
First submitted
7 May 2013
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
No

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.

    PubMed 28566529

  • 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.

    PubMed 28558709

  • 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.

    PubMed 28539413

  • 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.

    PubMed 26253152

Questions about this trial

What is this clinical trial studying?

A study testing Cash transfer in people with Acute Malnutrition, run by Action Contre la Faim at 1 site in Burkina Faso.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of child wasting (time frame: 3-monthly until 24 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01866124, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

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