Effects of Cash Transfers on Severe Acute Malnutrition

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Malnutrition
• Intervention / Treatment: Other: Outpatient therapeutic program, counseling and cash transfer; Other: Outpatient therapeutic program and counseling

• Study Type: Interventional
• Enrollment (Actual): 1600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kasaï Oriental
    • Mbuji-Mayi, Kasaï Oriental, Congo, The Democratic Republic of the, B.P. 440
      • Save the Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient therapeutic program, counseling and cash transfer; 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; 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.
Active Comparator: Outpatient therapeutic program and counseling; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UNICEF
• Collaborators: Save the Children
• Investigators: Study Chair: Eric Alain Ategbo, PhD, United Nations Children's Fund (UNICEF)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Malnutrition; Severe Acute Malnutrition; Democratic Republic of Congo; Cluster randomize trial; Cash Transfer
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: ARCCII-Nutrition