A Phase 4 interventional study of Small-Quantity Lipid-based nutrient supplement and Child's health and nutrition topics in Child Acute Malnutrition, sponsored by International Food Policy Research Institute. Completed at 1 site in Mali. Open to participants aged 6 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by International Food Policy Research Institute · Phase 4, Interventional, and Prevention
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.
Because of the intended dual role of BCC/SQ-LNS on child undernutrition in this study - e.g. to help prevent child undernutrition and enhance the coverage of screening, referral and treatment of SAM/MAM, it is necessary to combine two study designs to rigorously evaluate the impact of the proposed intervention and to tease out the contribution of prevention and enhanced coverage/treatment to the overall impact on child malnutrition.
The proposed study will therefore use two types of study designs. The first one is a repeated cross-sectional design that will compare select study outcomes between intervention and control groups at endline, after 24 months of program implementation. These cross-sectional surveys among children 6-23 months, at baseline and after 24 months (on different children) will be used to assess the impact of the intervention on the prevalence of several outcomes, including the prevalence of MAM/SAM and stunting, the coverage of MAM/SAM screening and maternal ENA/IYCF/WASH knowledge and practices. The second study design entails a longitudinal design whereby individual children will be recruited at 6 months of age and followed-up monthly until they reach 24 months of age.This design will allow us to assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 2,304 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →International Food Policy Research Institute is the lead sponsor of 36 studies on the registry; 4 are open to participants now.
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Cross-sectional study (baseline and endline)
Inclusion Criteria:
Exclusion Criteria:
Longitudinal study
Inclusion Criteria:
Exclusion Criteria:
Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age
Behavioral: Child's health and nutrition topics
* Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age * Caregivers with children 6-23 months of age that attend Counselling meetings will be provided with a monthly dose of SQ-LNS (20g/day)
Dietary Supplement: Small-Quantity Lipid-based nutrient supplement · Behavioral: Child's health and nutrition topics
A monthly dose of SQ-LNS (31 sachets of 20g) will be distributed to mothers attending counselling sessions
Also known as: SQ-LNS
Monthly group counselling meetings organized at village level. Caregivers of participating children are invited to attend monthly counselling meetings that treat topics on child nutrition, health, hygiene and good sanitary practices. During these visits children are also screened for acute malnutrition measuring arm circumference.
Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age
* Cross-sectional study * To calculate WHZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months)
* Cross-sectional study * Longitudinal study
Time frame: monthly from study inclusion at 6 months to 23 months of age and at study endline
Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm
* Longitudinal study * To calculate WHZ scores the 2006 WHO growth reference will be used
Time frame: Monthly from study inclusion at 6 months to 23 months of age
Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
* Cross-sectional study * Longitudinal study
Time frame: monthly from study inclusion at 6 months to 23 months of age and at study endline
Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
Mean WHZ-score in children 6-23 months of age
To calculate WHZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
Mean HAZ-score in children 6-23 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
Mean Mid-Upper Arm Circumference in children 6-23 months of age
Time frame: After 24 months of program implementation
Mean hemoglobin concentration at endline in children 6-23 months of age
Time frame: After 24 months of program implementation
Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age
Time frame: After 24 months of program implementation
Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm
To calculate WHZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Time frame: After 24 months of program implementation
Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)
Time frame: After 24 months of program implementation
Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Time frame: monthly from inclusion at 6 months to 23 months of age
Linear growth velocity (HAZ increment/month)
To calculate HAZ scores the 2006 WHO growth reference will be used
Time frame: monthly from inclusion at 6 months to 23 months
Ponderal growth velocity (WHZ increment/month)
To calculate WHZ scores the 2006 WHO growth reference will be used
Time frame: monthly from inclusion at 6 months to 23 months
Weight gain (weight increment/month)
Time frame: monthly from inclusion at 6 months to 23 months
Mid-Upper Arm Circumference gain (MUAC increment /month)
Time frame: monthly from inclusion at 6 months to 23 months
Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)
Malaria will be tested in case of fever (or recalled fever over last 24 hrs) using rapid tests
Time frame: monthly from inclusion at 6 months to 23 months
Relapse rate after treatment of MAM/SAM (proportion WHZ<-2 or MUAC<125mm or bilateral pitting edema after discharge from MAM or SAM treatment program over a total number of children treated
Time frame: monthly from inclusion at 6 months to 23 months
Child development (motor, language and personal-social development)
Determined by DMC-II
Time frame: After 24 months of program implementation
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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International Food Policy Research Institute