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| Name | Class |
|---|---|
| Helen Keller International | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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 |
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| PROMIS intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small-Quantity Lipid-based nutrient supplement | Dietary Supplement | A monthly dose of SQ-LNS (31 sachets of 20g) will be distributed to mothers attending counselling sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age |
| 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) |
| 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 |
| 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) |
| monthly from study inclusion at 6 months to 23 months of age and at study endline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 24 months of program implementation |
| Mean WHZ-score in children 6-23 months of age |
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Cross-sectional study (baseline and endline)
Inclusion Criteria:
Exclusion Criteria:
Longitudinal study
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Ruel, PhD | International Food Policy Research Institute | Study Director |
| Harouna Konde, MD | Helen Keller International - Mali | Principal Investigator |
| Lieven Huybregts, PhD | International Food Policy Research Institute | Principal Investigator |
| Agnes Le Port | International Food Policy Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bla and San Health Districts | Bla and San | Ségou | Mali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31454356 | Derived | Huybregts L, Le Port A, Becquey E, Zongrone A, Barba FM, Rawat R, Leroy JL, Ruel MT. 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. PLoS Med. 2019 Aug 27;16(8):e1002892. doi: 10.1371/journal.pmed.1002892. eCollection 2019 Aug. | |
| 28274214 |
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| Child's health and nutrition topics | Behavioral | 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. |
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To calculate WHZ scores the 2006 WHO growth reference will be used
| 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 | After 24 months of program implementation |
| Mean Mid-Upper Arm Circumference in children 6-23 months of age | After 24 months of program implementation |
| Mean hemoglobin concentration at endline in children 6-23 months of age | After 24 months of program implementation |
| Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age | 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 | 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 | 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) | 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 | 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 | 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 | monthly from inclusion at 6 months to 23 months |
| Weight gain (weight increment/month) | monthly from inclusion at 6 months to 23 months |
| Mid-Upper Arm Circumference gain (MUAC increment /month) | 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 | 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 | monthly from inclusion at 6 months to 23 months |
| Child development (motor, language and personal-social development) | Determined by DMC-II | After 24 months of program implementation |
| Derived |
| Huybregts L, Becquey E, Zongrone A, Le Port A, Khassanova R, Coulibaly L, Leroy JL, Rawat R, Ruel MT. The impact of integrated prevention and treatment on child malnutrition and health: the PROMIS project, a randomized control trial in Burkina Faso and Mali. BMC Public Health. 2017 Mar 9;17(1):237. doi: 10.1186/s12889-017-4146-6. |