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| ID | Type | Description | Link |
|---|---|---|---|
| DFATD | Other Grant/Funding Number | 52308/5252/0200 |
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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 often 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. A repeated cross-sectional study design among children 0-17 months, at baseline and at study endline (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 proposed study design entails a longitudinal design whereby individual children will be recruited at birth and followed-up monthly until they reach 18 months of age. We anticipate needing approximately 5 months to recruit the required number of children (estimated at 2,040- 1,020 in the control group and 1,020 in the intervention group). 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 |
|---|---|---|---|
| PROMIS intervention | Experimental |
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| control | Active Comparator | Monthly well-baby visits as prescribed by national policy This arm is the basic comparison arm. Caregivers are invited to frequent the health center once a month for well-baby visits. During these visits necessary vaccinations are administered, child growth and nutrition status is evaluated and preventive counseling on child nutrition and health is provided in large groups of caregivers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNS | Dietary Supplement | A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling |
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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 0-17 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 0-17 months) |
| monthly from study inclusion at 0 months to 17 months of age and at study endline |
| Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm |
| monthly from study inclusion at 0 months to 17 months of age |
| Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted) |
| monthly from study inclusion at 0 months to 17 months of age and at study endline |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of child stunting defined by HAZ<-2 in children 0-17 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 0 -17 months of age |
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Cross-sectional study (baseline and endline) (n=2,310)
Inclusion Criteria:
Exclusion Criteria:
- Index child should not present congenital deformations that hamper anthropometric measurements
Longitudinal study (n=2,180)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Ruel, PhD | International Food Policy Research Institute | Principal Investigator |
| Jean-Celestin Somda, MD | Helen Keller International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gourcy Health District | Gourcy | Région Du Nord | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31454347 | Derived | Becquey E, Huybregts L, Zongrone A, Le Port A, Leroy JL, Rawat R, Toure M, Ruel MT. Impact on child acute malnutrition of integrating a preventive nutrition package into facility-based screening for acute malnutrition during well-baby consultation: A cluster-randomized controlled trial in Burkina Faso. PLoS Med. 2019 Aug 27;16(8):e1002877. doi: 10.1371/journal.pmed.1002877. eCollection 2019 Aug. | |
| 28274214 |
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| Child's health and nutrition topics | Behavioral | After the well-baby visit. Caregivers will be invited to participate in a small group counseling or BCC (2-3 caregivers at a time). Every month a set of topics related to child's health and nutrition will be treated. These BCC sessions will be organized in an interactive way centering around the condition of the participating children. |
|
| National policy well-baby visits | Behavioral |
|
To calculate WHZ scores the 2006 WHO growth reference will be used
| After 24 months of program implementation |
| Mean HAZ-score in children 0-17 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 0-17 months of age | After 24 months of program implementation |
| Mean hemoglobin concentration in children 3-17 months of age | Hemocues will be used to measure Hb concentration | After 24 months of program implementation |
| Prevalence of child anemia (Hb concentration<10g/dL) in children 3 - 17 months of age | After 24 months of program implementation |
| Prevalence of severe acute child malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm in children 0-17 months of age | The MUAC criterion (115mm) is only used for children 6-17months of age | After 24 months of program implementation |
| Prevalence of severe stunting defined by a HAZ<-3 in children 0-17 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 0 to 17 months | To calculate HAZ score the 2006 WHO growth reference will be used | monthly from inclusion at 0 months to 17 months of age |
| Linear growth velocity (HAZ increment/month) | To calculate HAZ score the 2006 WHO growth reference will be used | monthly from inclusion at 0 months to 17 months of age |
| Ponderal growth velocity (WHZ increment/month) | To calculate WHZ score the 2006 WHO growth reference will be used | monthly from inclusion at 0 months to 17 months of age |
| Weight gain (weight increment/month) | monthly from inclusion at 0 months to 17 months of age |
| Mid-upper arm circumference gain (MUAC increment/month) | monthly from inclusion at 0 months to 17 moths of age |
| Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea) | Malaria will be tested in case of fever (or recalled fever over last 24hrs) use rapid tests | monthly from inclusion at 0 months to 17 moths of age |
| 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 total number of children treated) | monthly from inclusion at 0 months to 17 months of age |
| 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. |