NCT02460848

Effects of Unconditional Cash Transfers on the Management of Severe Acute Malnutrition (SAM) in the Democratic Republic of Congo: a Cluster Randomized Trial

Completed NA Last updated 4 January 2016

What this trial tests

NA trial testing Outpatient therapeutic program, counseling and cash transfer in Severe Malnutrition in 1,600 participants. Completed in 1 January 2016.

Timeline

1 July 2015

Primary endpoint
1 November 2015

1 January 2016

Quick facts

Lead sponsor	UNICEF
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	1,600
Start date	1 July 2015
Primary completion	1 November 2015
Estimated completion	1 January 2016
Sites	1 location across Democratic Republic of the Congo

Drugs / interventions tested

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

Conditions studied

• Severe Malnutrition — all drugs for Severe Malnutrition →

Sponsor

UNICEF — full company profile →

Who can join

Adults 6 Months to 59 Months, any sex, with Severe Malnutrition. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Grellety E, Babakazo P, Bangana A, Mwamba G, et al · · 2017 · cited 38× · PMID 28441944 · DOI 10.1186/s12916-017-0848-y
2. Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low- and middle-income countries.
   Pega F, Pabayo R, Benny C, Lee EY, et al · · 2022 · cited 25× · PMID 35348196 · DOI 10.1002/14651858.cd011135.pub3