NCT02460848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

May 27, 2015

Last Update Submit

January 4, 2016

Conditions

Severe Malnutrition

Keywords

MalnutritionSevere Acute MalnutritionCash TransferDemocratic Republic of CongoCluster randomize trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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

  • Relapse rate

    At 2, 3 and 4 months following discharge

  • Transfer rate from outpatient therapeutic program to inpatient therapeutic program

    One month average

  • +10 more secondary outcomes

Study Arms (2)

Outpatient therapeutic program, counseling and cash transfer

EXPERIMENTAL

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

Outpatient therapeutic program and counseling

ACTIVE COMPARATOR

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

Interventions

Outpatient therapeutic program, counseling and cash transferOTHER

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, counseling and cash transfer
Outpatient therapeutic program and counselingOTHER
Outpatient therapeutic program and counseling

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Living in the catchment area of one of the 20 outpatient therapeutic program site participating in this cluster randomized trial;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Save the Children

Mbuji-Mayi, East Kasai, B.P. 440, Democratic Republic of the Congo

Location

Related Publications (1)

  • 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.

    PMID: 28441944DERIVED

MeSH Terms

Conditions

MalnutritionSevere Acute Malnutrition

Interventions

Counseling

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eric Alain Ategbo, PhD

    United Nations Children's Fund (UNICEF)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 2, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

DE(1)