Effects of Cash Transfers on Severe Acute Malnutrition

Severe Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460848
• Other study ID #: ARCCII-Nutrition
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: January 4, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: UNICEF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Congo, Democratic Republic of the: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition
• Severe Malnutrition

Intervention

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.
• Outpatient therapeutic program and counseling

Locations

Country	Name	City	State
Congo, The Democratic Republic o	Save the Children	Mbuji-Mayi	Kasaï Oriental

Sponsors (2)

Lead Sponsor	Collaborator
UNICEF	Save the Children

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Recovery rate in the outpatient therapeutic program		At 8 week	No
Secondary	Length of stay in the outpatient therapeutic program		One month (average)	No
Secondary	Default rate in the outpatient therapeutic program	Patient who failed to appear for two consecutive weeks during the follow-up visits.	Two weeks	No
Secondary	Relapse rate	Patient who reach inclusion criteria within 2 months following discharge.	At 2, 3 and 4 months following discharge	No
Secondary	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	No
Secondary	Failure rate in the outpatient therapeutic program	Patients who failed to reach after 3 months the recovery criteria.	Up to three months	No
Secondary	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	No
Secondary	Death rate	Death from any cause during follow-up.	At 6 week, 8 week and 6 month	No
Secondary	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	No
Secondary	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	No
Secondary	Change in Growth rates	Growth will be measured every week in the outpatient therapeutic program and every month after discharge.	At 6 month	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Satisfaction of parents and acceptability	Survey will be conducted in the households at the end of the study.	At 6 month	No