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

Not Applicable

Completed

• Conditions: Child Nutrition Disorders
• Interventions: Dietary Supplement: Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.; Dietary Supplement: RUSF (ready-to-use supplementary foods) Supplementary Plumpy®

• Registration Number: NCT01097889
• Lead Sponsor: The Hospital for Sick Children

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

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-11
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-02
• Study Completion: 2010-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.	-
Treatment Group 2	RUSF (ready-to-use supplementary foods) Supplementary Plumpy®	-

Primary Outcome Measures

Name	Time	Method
Survival Analysis	Baseline and at 16 Weeks	Recovery rates in children from malnutrition

Secondary Outcome Measures

Name	Time	Method
Anthropometrics Changes	Baseline, Weeks 2,4,6,8,10,12,14,16	Height, weight and middle upper arm circumference (MUAC)
Household Practices Questionnaire	At 16 weeks

Trial Locations

Locations (2)

Regional Health Board - Health Posts in South Nations and Nationalities Peoples Region (SNNPR; 🇪🇹 Sidama Zone, Southern Ethiopia, Ethiopia

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada