Severe Malnutrition
Conditions
Keywords
Malnutrition, Severe Acute Malnutrition, Cash Transfer, Democratic Republic of Congo, Cluster randomize trial
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.
Interventions
OTHEROutpatient therapeutic program, counseling and cash transfer
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.
OTHEROutpatient therapeutic program and counseling
Sponsors
Save the Children
UNICEF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery rate in the outpatient therapeutic program | At 6 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Two weeks | Patient who failed to appear for two consecutive weeks during the follow-up visits. |
| Relapse rate | At 2, 3 and 4 months following discharge | Patient who reach inclusion criteria within 2 months following discharge. |
| Transfer rate from outpatient therapeutic program to inpatient therapeutic program | One month average | Patient who develop signs of a serious medical complication according to the national protocol are transfer to the inpatient therapeutic program. |
| Failure rate in the outpatient therapeutic program | Up to three months | Patients who failed to reach after 3 months the recovery criteria. |
| Morbidity rate | At 6 week, 8 week and 6 month | 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. |
| Diet replacement & Intra-household dispatching of the therapeutic food | One month average | 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. |
| Weight gain | At 6 week, 8 week and 6 month | Weight gain will be assessed every week in the outpatient therapeutic program and every month after discharge. |
| Mid-Upper Arm Circumference gain | At 6 week, 8 week and 6 month | Mid-upper arm circumference gain will be assessed every week in the outpatient therapeutic program and every month after discharge. |
| Change in Growth rates | At 6 month | Growth will be measured every week in the outpatient therapeutic program and every month after discharge. |
| Change in the Individual Dietary Diversity Score (IDDS) | At 6 week, 8 week and 6 month | 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. |
| Change in the Household Dietary Diversity Score (HDDS) | At 6 month | 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. |
| Satisfaction of parents and acceptability | At 6 month | Survey will be conducted in the households at the end of the study. |
| Death rate | At 6 week, 8 week and 6 month | Death from any cause during follow-up. |
Countries
Democratic Republic of the Congo
Outcome results
None listed