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Effects of Cash Transfers on Severe Acute Malnutrition

Primary Purpose

Severe Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
Outpatient therapeutic program, counseling and cash transfer
Outpatient therapeutic program and counseling
Sponsored by
UNICEF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Severe Malnutrition focused on measuring Malnutrition, Severe Acute Malnutrition, Cash Transfer, Democratic Republic of Congo, Cluster randomize trial

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Save the Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Outpatient therapeutic program, counseling and cash transfer

Outpatient therapeutic program and counseling

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recovery rate in the outpatient therapeutic program
Length of stay in the outpatient therapeutic program
Default rate in the outpatient therapeutic program
Patient who failed to appear for two consecutive weeks during the follow-up visits.
Relapse rate
Patient who reach inclusion criteria within 2 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.
Failure rate in the outpatient therapeutic program
Patients who failed to reach after 3 months the recovery criteria.
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.
Death rate
Death from any cause during follow-up.
Weight gain
Weight gain will be assessed every week in the outpatient therapeutic program and every month after discharge.
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.
Change in Growth rates
Growth will be measured every week in the outpatient therapeutic program and every month after discharge.
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.
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.
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.
Satisfaction of parents and acceptability
Survey will be conducted in the households at the end of the study.

Full Information

First Posted
May 27, 2015
Last Updated
January 4, 2016
Sponsor
UNICEF
Collaborators
Save the Children
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1. Study Identification

Unique Protocol Identification Number
NCT02460848
Brief Title
Effects of Cash Transfers on Severe Acute Malnutrition
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UNICEF
Collaborators
Save the Children

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Malnutrition
Keywords
Malnutrition, Severe Acute Malnutrition, Cash Transfer, Democratic Republic of Congo, Cluster randomize trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient therapeutic program, counseling and cash transfer
Arm Type
Experimental
Arm Description
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).
Arm Title
Outpatient therapeutic program and counseling
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Outpatient therapeutic program, counseling and cash transfer
Intervention Description
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
Intervention Name(s)
Outpatient therapeutic program and counseling
Primary Outcome Measure Information:
Title
Recovery rate in the outpatient therapeutic program
Description
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.
Time Frame
At 6 week
Secondary Outcome Measure Information:
Title
Recovery rate in the outpatient therapeutic program
Time Frame
At 8 week
Title
Length of stay in the outpatient therapeutic program
Time Frame
One month (average)
Title
Default rate in the outpatient therapeutic program
Description
Patient who failed to appear for two consecutive weeks during the follow-up visits.
Time Frame
Two weeks
Title
Relapse rate
Description
Patient who reach inclusion criteria within 2 months following discharge.
Time Frame
At 2, 3 and 4 months following discharge
Title
Transfer rate from outpatient therapeutic program to inpatient therapeutic program
Description
Patient who develop signs of a serious medical complication according to the national protocol are transfer to the inpatient therapeutic program.
Time Frame
One month average
Title
Failure rate in the outpatient therapeutic program
Description
Patients who failed to reach after 3 months the recovery criteria.
Time Frame
Up to three months
Title
Morbidity rate
Description
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.
Time Frame
At 6 week, 8 week and 6 month
Title
Death rate
Description
Death from any cause during follow-up.
Time Frame
At 6 week, 8 week and 6 month
Title
Weight gain
Description
Weight gain will be assessed every week in the outpatient therapeutic program and every month after discharge.
Time Frame
At 6 week, 8 week and 6 month
Title
Mid-Upper Arm Circumference gain
Description
Mid-upper arm circumference gain will be assessed every week in the outpatient therapeutic program and every month after discharge.
Time Frame
At 6 week, 8 week and 6 month
Title
Change in Growth rates
Description
Growth will be measured every week in the outpatient therapeutic program and every month after discharge.
Time Frame
At 6 month
Title
Diet replacement & Intra-household dispatching of the therapeutic food
Description
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.
Time Frame
One month average
Title
Change in the Individual Dietary Diversity Score (IDDS)
Description
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.
Time Frame
At 6 week, 8 week and 6 month
Title
Change in the Household Dietary Diversity Score (HDDS)
Description
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.
Time Frame
At 6 month
Title
Satisfaction of parents and acceptability
Description
Survey will be conducted in the households at the end of the study.
Time Frame
At 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Alain Ategbo, PhD
Organizational Affiliation
United Nations Children's Fund (UNICEF)
Official's Role
Study Chair
Facility Information:
Facility Name
Save the Children
City
Mbuji-Mayi
State/Province
Kasaï Oriental
ZIP/Postal Code
B.P. 440
Country
Congo, The Democratic Republic of the

12. IPD Sharing Statement

Citations:
PubMed Identifier
28441944
Citation
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.
Results Reference
derived

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Effects of Cash Transfers on Severe Acute Malnutrition

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