Child Acute Malnutrition Clinical Trial
Official title:
The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02323815 -
The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study
|
Phase 4 |