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

Acute Malnutrition Clinical Trial

— MAM'Out  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866124
• Other study ID #: ACF0213
• Secondary ID: 1U01GH000646-01
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: October 9, 2015
• Start date: May 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Action Contre la Faim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Public Health- Building LAMIZANA, 09 BP 7009 9 OUAGADOUGOU BURKINA FASO
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1278
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Malnutrition
• Malnutrition

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Burkina Faso	Action Contre la Faim - Burkina Faso	Diapaga	Tapoa

Sponsors (4)

Lead Sponsor	Collaborator
Action Contre la Faim	AgroParisTech, Centers for Disease Control and Prevention, University Ghent

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3-monthly until 24 months after inclusion	No
Primary	Incremental cost-effectiveness ratio	Calculation of a cost-effectiveness ratio at the end of the study	24 months after inclusion	No
Secondary	cumulative incidence of the state of stunting		3-monthly until 24 months after inclusion	No
Secondary	mean height-for-age Z-score		3-monthly until 24 months after inclusion	No
Secondary	mean weight-for-length Z-score		3-monthly until 24 months after inclusion	No
Secondary	mid-upper arm circumference (MUAC)		3-monthly until 24 months after inclusion	No
Secondary	edema		3-monthly until 24 months after inclusion	No
Secondary	Prevalence of diarrhea		3-monthly until 24 months after inclusion	No
Secondary	Prevalence of acute respiratory infections		3-monthly until 24 months after inclusion	No
Secondary	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	3-monthly until 24 months after inclusion	No