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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Child Nutrition Disorders
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 2600
- Locations
- 2
- Primary Endpoint
- Survival Analysis
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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
Investigators
Stanley Zlotkin
Chief, Global Child Health
The Hospital for Sick Children
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Survival Analysis
Time Frame: Baseline and at 16 Weeks
Recovery rates in children from malnutrition
Secondary Outcomes
- Anthropometrics Changes(Baseline, Weeks 2,4,6,8,10,12,14,16)
- Household Practices Questionnaire(At 16 weeks)