Effects of Cash Transfers on Severe Acute Malnutrition

NCT ID: NCT02460848

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-01-31

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.

Conditions

Severe Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Outpatient therapeutic program, counseling and cash transfer

Intervention Type: OTHER

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.

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).

Group Type: ACTIVE_COMPARATOR

Outpatient therapeutic program and counseling

Intervention Type: OTHER

Interventions

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.

Intervention Type: OTHER

Outpatient therapeutic program and counseling

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Save the Children

OTHER

Sponsor Role: collaborator

UNICEF

OTHER

Sponsor Role: lead

Responsible Party

Emmanuel Grellety

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Alain Ategbo, PhD

Role: STUDY_CHAIR

United Nations Children's Fund (UNICEF)

Locations

Save the Children

Mbuji-Mayi, East Kasai, Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

References

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.

Reference Type: DERIVED

PMID: 28441944 (View on PubMed)

Other Identifiers

ARCCII-Nutrition

Identifier Type: -

Identifier Source: org_study_id