Effects of Cash Transfers on Severe Acute Malnutrition

• ClinicalTrials.gov Identifier: NCT02460848
• Recruitment Status: Completed
• First Posted: June 2, 2015
• Last Update Posted: January 5, 2016
• Sponsor: UNICEF
• Collaborator: Save the Children
• Information provided by (Responsible Party): Emmanuel Grellety, UNICEF

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Severe Malnutrition	Other: Outpatient therapeutic program, counseling and cash transfer; Other: Outpatient therapeutic program and counseling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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 Start Date: July 2015
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: January 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Recovery rate in the outpatient therapeutic program [ Time Frame: 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 Outcome Measures :

1. Recovery rate in the outpatient therapeutic program [ Time Frame: At 8 week ]
2. Length of stay in the outpatient therapeutic program [ Time Frame: One month (average) ]
3. Default rate in the outpatient therapeutic program [ Time Frame: Two weeks ]
   Patient who failed to appear for two consecutive weeks during the follow-up visits.
4. Relapse rate [ Time Frame: At 2, 3 and 4 months following discharge ]
   Patient who reach inclusion criteria within 2 months following discharge.
5. Transfer rate from outpatient therapeutic program to inpatient therapeutic program [ Time Frame: One month average ]
   Patient who develop signs of a serious medical complication according to the national protocol are transfer to the inpatient therapeutic program.
6. Failure rate in the outpatient therapeutic program [ Time Frame: Up to three months ]
   Patients who failed to reach after 3 months the recovery criteria.
7. Morbidity rate [ Time Frame: 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.
8. Death rate [ Time Frame: At 6 week, 8 week and 6 month ]
   Death from any cause during follow-up.
9. Weight gain [ Time Frame: 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.
10. Mid-Upper Arm Circumference gain [ Time Frame: 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.
11. Change in Growth rates [ Time Frame: At 6 month ]
    Growth will be measured every week in the outpatient therapeutic program and every month after discharge.
12. Diet replacement & Intra-household dispatching of the therapeutic food [ Time Frame: 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.
13. Change in the Individual Dietary Diversity Score (IDDS) [ Time Frame: 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.
14. Change in the Household Dietary Diversity Score (HDDS) [ Time Frame: 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.
15. Satisfaction of parents and acceptability [ Time Frame: At 6 month ]
    Survey will be conducted in the households at the end of the study.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 59 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Congo, The Democratic Republic of the

Save the Children

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

Sponsors and Collaborators

UNICEF

Save the Children

Investigators

• Study Chair: Eric Alain Ategbo, PhD; United Nations Children's Fund (UNICEF)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Emmanuel Grellety, Principal Investigator, UNICEF
• ClinicalTrials.gov Identifier: NCT02460848
• Other Study ID Numbers: ARCCII-Nutrition
• First Posted: June 2, 2015
• Last Update Posted: January 5, 2016
• Last Verified: January 2016

Keywords provided by Emmanuel Grellety, UNICEF:

Malnutrition; Severe Acute Malnutrition; Cash Transfer; Democratic Republic of Congo; Cluster randomize trial

Additional relevant MeSH terms:

Malnutrition; Severe Acute Malnutrition; Nutrition Disorders