Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition

Study Overview
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Brief Summary
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Supplementary feeding programs for children with moderate acute malnutrition have been implemented in developing countries using treatment foods with minimal or no evidence of their effectiveness. Fortified peanut paste is a popular new treatment food for children with severe and moderate malnutrition. Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods in children with moderate malnutrition by comparing differences in performance indicators (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each group. This proposed research project will evaluate the relative effectiveness of two non-identical treatment foods for the treatment of moderate acute malnutrition in children

Detailed Description
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This research protocol will be embedded as a component of the UN World Food Programme (WFP) -supported Supplementary Feeding programmes in Ethiopia. The proposed study is a prospective cluster-randomized equivalence trial that will compare the relative effectiveness of two feeding interventions in four woredas (districts). Research will be implemented in two comparable woredas (one with CSB and one with RUSF), in two different areas in Sidama zone that represent different livelihood zones, main source of crop income, and level of food insecurity

Official Title
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Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition in Children 6-60 Months of Age in Southern Ethiopia

Conditions
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Child Nutrition Disorders

Intervention / Treatment
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* Dietary Supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.
* Dietary Supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All children 6 to 60 months of age who are identified as malnourished based on MUAC measurements with WFH ≥70 to <80%. Exclusion Criteria: Children with WFH < 70% or presenting with bilateral pitting oedema (they will be referred to therapeutic feeding programme). Children with any illness or clinical condition that prevents them from safely ingesting either supplementary foods. A child is medically assessed upon admission for any complicated clinical condition (oedema, malaria, vomiting, chronic diarrhea, infections, appetite, etc) that would require medical care and those children will be referred to the therapeutic feeding programme. All children transferred from the therapeutic feeding programme directly into the supplementary feeding programme - however they will not be included in the research study. Children with WFH > 80% but MUAC 110 to 120 mm- they will be admitted to SFP however will not be included in the research study.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group 1<br> | Dietary Supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.<br>* A daily ration equivalent of 300g CSB and 32g vegetable oil Bi-weekly distribution of premix of 4.2kg CSB with 0.5L vegetable oil. Estimated 1413 kcal, 47g protein<br>|
| Experimental: Treatment Group 2<br> | Dietary Supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy®<br>* Peanut-based fortified supplement One 92g sachet eaten throughout the day Bi-weekly distributions of 14 sachets 500 kcal and 13g protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Analysis | Recovery rates in children from malnutrition | Baseline and at 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometrics Changes | Height, weight and middle upper arm circumference (MUAC) | Baseline, Weeks 2,4,6,8,10,12,14,16 | 
| Household Practices Questionnaire |  | At 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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United Nations World Food Programme, blended food (CSB), ready-to-use supplementary foods (RUSF), Plumpy®