Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition (MAM) in Children: Sierra Leone Cost-Effectiveness Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 2,691
- Locations
- 1
- Primary Endpoint
- Effectiveness assessed by recovery from MAM, defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm within the 12-week treatment period
Study Overview
Brief Summary
The research seeks to determine the relative effectiveness and cost effectiveness of alternative supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal program settings. The results of this study will guide decisions about what commodities to use in supplementary feeding programs in particular contexts and populations, and what factors need to be addressed to ensure maximum effectiveness in the treatment of moderate malnutrition.
Tufts University, Washington University in St. Louis, School of Medicine, Sierra Leone Ministry of Health and Sanitation (MoHS), Project Peanut Butter, Caritas Bo, World Food Programme (WFP), and the United States Agency for International Development (USAID) are collaborating to conduct an assessment of the effectiveness, cost, and cost-effectiveness of food aid commodities in treating moderate acute malnutrition (MAM) in young children. The study comparison is based on a targeted food delivery to children 6-59 months who are screened for MAM. Study participants will receive one of four approximately isoenergetic test foods:
- Super Cereal Plus (SC+) with amylase
- Corn-soy Blend Plus (CSB+) and fortified vegetable oil
- Corn-soy Whey Blend (CSWB) and fortified vegetable oil (CSWB is a new product which is a modified version of CSB)
- Ready-to-use Supplementary Food (RUSF, lipid-based)
Detailed Description
The proposed research seeks to determine the relative effectiveness and cost effectiveness of alternative supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal program settings. The results of this study will guide decisions about what commodities to use in supplementary feeding programs in particular contexts and populations, and what factors need to be addressed to ensure maximum effectiveness in the treatment of moderate malnutrition.
Tufts University, Washington University in St. Louis, School of Medicine, Sierra Leone Ministry of Health and Sanitation (MoHS), Project Peanut Butter, Caritas Bo, World Food Programme (WFP), and the United States Agency for International Development (USAID) are collaborating to conduct an assessment of the effectiveness, cost, and cost-effectiveness of food aid commodities in treating moderate acute malnutrition (MAM) in young children. The study comparison is based on a targeted food delivery to children 6-59 months who are screened for MAM. Study participants will receive one of four approximately isoenergetic test foods:
- Super Cereal Plus (SC+) with amylase
- Corn-soy Blend Plus (CSB+) and fortified vegetable oil
- Corn-soy Whey Blend (CSWB) and fortified vegetable oil (CSWB is a new product which is a modified version of CSB)
- Ready-to-use Supplementary Food (RUSF, lipid-based)
Type of study: This will be a prospective, cluster-randomized, controlled clinical effectiveness trial.
Peripheral Health Units (PHU) will be selected within the Pujehun District in Sierra Leone. These 29 PHUs and the villages they serve will be used as the study sites to test the effectiveness of four supplementary foods in the treatment of MAM. The PHUs will be grouped into 4 to represent each food or arm of the study. The study is targeting 6000 children in total: 1500 children per arm. Children will be enrolled and graduated based on mid-upper arm circumference (MUAC); weight and height will be recorded as well and also used in final analysis. Locations (communities, clinics) will be assigned to one of the four arms (that is, foods to be tested). The foods distributed as part of the study will require a safe storage location.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 59 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Child diagnosed with MAM based on MUAC and enrolled to receive a ration from a feeding site (i.e. enrolled in the SFP)
Exclusion Criteria
- •Children with bipedal oedema
- •Children receiving food rations from another organization (e.g. USAID, WFP, UNICEF) for treatment of MAM
- •Children who have previously been enrolled in the study (they are not eligible to be re-enrolled in the study but are still eligible to receive food)
Arms & Interventions
Corn-soy Blend Plus and Vegetable Oil
Intervention: Supplementary Food (Dietary Supplement)
Corn-soy Whey Blend and Vegetable Oil
Intervention: Supplementary Food (Dietary Supplement)
Ready-to-Use-Supplementary Food
Intervention: Supplementary Food (Dietary Supplement)
Super Cereal Plus with amylase
Intervention: Supplementary Food (Dietary Supplement)
Outcomes
Primary Outcomes
Effectiveness assessed by recovery from MAM, defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm within the 12-week treatment period
Time Frame: 12 weeks
Graduation from MAM, defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm within the 12-week treatment period
Cost-Effectiveness
Time Frame: 12 weeks
Assess program costs among the four study arms including fixed, start-up and ongoing costs of food supplements, repackaging, transportation, storage, distribution, other clinical and SBCC programming activities, and caregivers' opportunity costs. Link these costs with the effectiveness outcomes to determine and compare the cost-effectiveness of using each supplement to treat MAM (e.g. Cost per Case of MAM graduated).
WHZ => -2 SD among children treated for up to 12 weeks or until reaching graduation based on MUAC whose WHZ was < -2 SD at enrollment
Time Frame: 12 weeks
Percent of children enrolled in MAM treatment whose WHZ =\> -2 SD (calculated based on height at enrollment and weight at graduation) at graduation based on MUAC or at 12 weeks of treatment, whichever is earliest, taking into consideration their WHZ at enrollment.
Secondary Outcomes
- Weight (g/kg/d)(4 weeks)
- MUAC (mm/d) gain within first 4 weeks(4 weeks)
- Change in weight-for-height Z score (WHZ) and height-for-age Z score (HAZ), height gain (mm/d), enrollment to discharge and 1,3,6 months post discharge(6 months)
- Time to graduation(12 weeks)
- Post-treatment growth status(Up to 6 months after graduation/discharge)
- Achieving WHZ >= -2 SD (using weight at the last visit and length at admission) at discharge and at 1,3 and 6 months post discharge(Up to 6 months after graduation/discharge)
Investigators
Lindsey Green
Beatrice Lorge Rogers
Tufts University