NCT02323815: PROMIS-Mali

The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study

Completed Phase 4 Last updated 9 March 2018

What this trial tests

Phase 4 trial testing Small-Quantity Lipid-based nutrient supplement in Child Acute Malnutrition in 2,304 participants. Completed in 1 September 2017.

Timeline

1 February 2015

Primary endpoint
5 May 2017

1 September 2017

Quick facts

Lead sponsor	International Food Policy Research Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	2,304
Start date	1 February 2015
Primary completion	5 May 2017
Estimated completion	1 September 2017
Sites	1 location across Mali

Drugs / interventions tested

• Small-Quantity Lipid-based nutrient supplement
• Child's health and nutrition topics

Conditions studied

• Child Acute Malnutrition — all drugs for Child Acute Malnutrition →

Sponsor

International Food Policy Research Institute

Who can join

Adults 6 Months to 23 Months, any sex, with Child Acute Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM

In Sub-Saharan Africa, there is often poor integration between programs to treat child acute malnutrition and programs that focus on the prevention of acute and chronic undernutrition - resulting in many missed opportunities for using prevention platforms to screen and refer SAM children, or for using screening and referral platforms to provide prevention services.

This project will address two critical gaps related to the integration of preventive and treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically integrated into routine health-center visits or mainstreamed into community outreach programs; and 2) screening programs do not offer any preventive services for those children found not to be suffering from MAM/SAM at the time of screening; mothers of children identified as non-MAM/SAM case are usually sent home without receiving any health or nutrition inputs and as a result, may fail to come back for screening because they do not see any tangible benefit associated with their participation in the screening. This project will specifically address these gaps by assessing the effect of an integrated approach consisting of higher screening coverage and preventive Behavior Change Communication (BCC) + Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment of child undernutrition.

Publications & conference data

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

1. Preventive lipid-based nutrient supplements given with complementary foods to infants and young children 6 to 23 months of age for health, nutrition, and developmental outcomes.
   Das JK, Salam RA, Hadi YB, Sadiq Sheikh S, et al · · 2019 · cited 74× · PMID 31046132 · DOI 10.1002/14651858.cd012611.pub3
2. Impact on child acute malnutrition of integrating small-quantity lipid-based nutrient supplements into community-level screening for acute malnutrition: A cluster-randomized controlled trial in Mali.
   Huybregts L, Le Port A, Becquey E, Zongrone A, et al · · 2019 · cited 35× · PMID 31454356 · DOI 10.1371/journal.pmed.1002892
3. The impact of integrated prevention and treatment on child malnutrition and health: the PROMIS project, a randomized control trial in Burkina Faso and Mali.
   Huybregts L, Becquey E, Zongrone A, Le Port A, et al · · 2017 · cited 16× · PMID 28274214 · DOI 10.1186/s12889-017-4146-6