Clinical trial NCT02460848: Effects of Cash Transfers on Severe Acute Malnutrition
Official title: Effects of Unconditional Cash Transfers on the Management of Severe Acute Malnutrition (SAM) in the Democratic Republic of Congo: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Malnutrition
Keywords: Malnutrition
Severe Acute Malnutrition
Cash Transfer
Democratic Republic of Congo
Cluster randomize trial
Lead sponsor: UNICEF
Sponsor class: OTHER
Collaborators: name: Save the Children
First posted: 2015-06-02
Enrollment: 1600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recovery rate in the outpatient therapeutic program
timeFrame: At 6 week
Secondary outcomes:
measure: Recovery rate in the outpatient therapeutic program
timeFrame: At 8 week
measure: Length of stay in the outpatient therapeutic program
timeFrame: One month (average)
measure: Default rate in the outpatient therapeutic program
timeFrame: Two weeks
measure: Relapse rate
timeFrame: At 2, 3 and 4 months following discharge
measure: Transfer rate from outpatient therapeutic program to inpatient therapeutic program
timeFrame: One month average
measure: Failure rate in the outpatient therapeutic program
timeFrame: Up to three months
measure: Morbidity rate
timeFrame: At 6 week, 8 week and 6 month
measure: Death rate
timeFrame: At 6 week, 8 week and 6 month
measure: Weight gain
timeFrame: At 6 week, 8 week and 6 month
measure: Mid-Upper Arm Circumference gain
timeFrame: At 6 week, 8 week and 6 month
measure: Change in Growth rates
timeFrame: At 6 month
measure: Diet replacement & Intra-household dispatching of the therapeutic food
timeFrame: One month average
measure: Change in the Individual Dietary Diversity Score (IDDS)
timeFrame: At 6 week, 8 week and 6 month
measure: Change in the Household Dietary Diversity Score (HDDS)
timeFrame: At 6 month
measure: Satisfaction of parents and acceptability
timeFrame: At 6 month
Other outcomes:
Locations:
city: Mbuji-Mayi
country: Congo, The Democratic Republic of the
facility: Save the Children
state: Kasaï Oriental
Study officials:
affiliation: United Nations Children's Fund (UNICEF)
name: Eric Alain Ategbo, PhD
role: STUDY_CHAIR
References:
citation: Grellety E, Babakazo P, Bangana A, Mwamba G, Lezama I, Zagre NM, Ategbo EA. Effects of unconditional cash transfers on the outcome of treatment for severe acute malnutrition (SAM): a cluster-randomised trial in the Democratic Republic of the Congo. BMC Med. 2017 Apr 26;15(1):87. doi: 10.1186/s12916-017-0848-y.