Effects of Cash Transfers on Severe Acute Malnutrition

Study Overview
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Brief Summary
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Cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and development. While cash transfer to vulnerable households has shown a long-term positive impact on growth and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will perform a cluster-randomized trial to investigate during 6 months the effects of unconditional cash transfers on the management of severe acute malnutrition (SAM) in children from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.

Official Title
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Effects of Unconditional Cash Transfers on the Management of Severe Acute Malnutrition (SAM) in the Democratic Republic of Congo: a Cluster Randomized Trial

Conditions
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Severe Malnutrition

Intervention / Treatment
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* Other: Outpatient therapeutic program, counseling and cash transfer
* Other: Outpatient therapeutic program and counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living in the catchment area of one of the 20 outpatient therapeutic program site participating in this cluster randomized trial; 6-59 months of age; Weight for Height Zscore <-3 SD (WHO Growth Standards 2006) and/or Mid-Upper Arm Circumference <115mm and/or with bilateral edema; No major clinical complications; Positive appetite test; Accept to participate at the study. Exclusion Criteria: Not living in the catchment area of the outpatient therapeutic program site of the cluster randomized trial; Weight-for-Height Z-score ≥-3 (WHO Growth Standards 2006) and Mid-Upper Arm Circumference ≥115mm without bilateral edema; Major clinical complications; Failure to appetite test; Refuse to participate at the study.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient therapeutic program, counseling and cash transfer<br>Ten outpatient therapeutic program sites (OTP) will be randomly allocated to unconditional cash transfer for children admitted for treatment of SAM according to the integrated management of acute malnutrition national protocol which will be associated with counseling on infant and young child feeding (IYCF). | Other: Outpatient therapeutic program, counseling and cash transfer<br>* Each household will receive an unconditional cash transfer of $40 value every month during a 6 months' period. The amount of cash per household per month was defined according to the results of the Household Economy Approach survey. This amount represents 70% of supplement to the monthly average household income characterized as very poor to meet their basic needs. This threshold corresponds to the total of food and income necessary to cover 100% of energy needs food (2100 kcal per day per person), the costs associated with the preparation and consumption of food (e.g. salt, soap, kerosene and / or firewood for cooking and basic lighting) and finally all expenses for access to water for human consumption.<br>|
| Active Comparator: Outpatient therapeutic program and counseling<br>Ten outpatient therapeutic program sites (OTP) will be randomly allocated for children admitted for treatment of SAM according to the integrated management of acute malnutrition national protocol which will be associated with counseling on infant and young child feeding (IYCF). | Other: Outpatient therapeutic program and counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate in the outpatient therapeutic program | Recovery is defined for patient of 6 to 59 months old as Weight-for-Height Z-score ≥-1.5 SD (WHO Growth Standards 2006) or Mid-Upper Arm Circumference ≥125mm at two consecutive visits and absence of bilateral edema for 14 days. | At 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate in the outpatient therapeutic program |  | At 8 week | 
| Length of stay in the outpatient therapeutic program |  | One month (average) | 
| Default rate in the outpatient therapeutic program | Patient who failed to appear for two consecutive weeks during the follow-up visits. | Two weeks | 
| Relapse rate | Patient who reach inclusion criteria within 2 months following discharge. | At 2, 3 and 4 months following discharge | 
| Transfer rate from outpatient therapeutic program to inpatient therapeutic program | Patient who develop signs of a serious medical complication according to the national protocol are transfer to the inpatient therapeutic program. | One month average | 
| Failure rate in the outpatient therapeutic program | Patients who failed to reach after 3 months the recovery criteria. | Up to three months | 
| Morbidity rate | ARI, diarrhoea, anaemia and malaria incidence. Morbidity will be assessed every week in the outpatient therapeutic program and every month after discharge by a locally pre-tested standardized questionnaire. | At 6 week, 8 week and 6 month | 
| Death rate | Death from any cause during follow-up. | At 6 week, 8 week and 6 month | 
| Weight gain | Weight gain will be assessed every week in the outpatient therapeutic program and every month after discharge. | At 6 week, 8 week and 6 month | 
| Mid-Upper Arm Circumference gain | Mid-upper arm circumference gain will be assessed every week in the outpatient therapeutic program and every month after discharge. | At 6 week, 8 week and 6 month | 
| Change in Growth rates | Growth will be measured every week in the outpatient therapeutic program and every month after discharge. | At 6 month | 
| Diet replacement & Intra-household dispatching of the therapeutic food | Diet replacement & Intra-household dispatching of the therapeutic food will be assessed with the household every week during the recovery period by a locally pre-tested standardized questionnaire. | One month average | 
| Change in the Individual Dietary Diversity Score (IDDS) | IDDS for measurement of food access of the children will be assessed with the household every week during the recovery period and every month after discharge by a locally pre-tested standardized questionnaire. | At 6 week, 8 week and 6 month | 
| Change in the Household Dietary Diversity Score (HDDS) | HDDS for measurement of food access will be assessed with the household at the beginning and the end of the study by a locally pre-tested standardized questionnaire. | At 6 month | 
| Satisfaction of parents and acceptability | Survey will be conducted in the households at the end of the study. | At 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Severe Acute Malnutrition, Cash Transfer, Democratic Republic of Congo, Cluster randomize trial