- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03146897
Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition
Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition (MAM) in Children: Sierra Leone Cost-Effectiveness Study
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Supplementary food rations will be delivered for up to 12 weeks from enrollment (enrollment takes place when a child is diagnosed with MAM in accordance with a mid-upper-arm-circumference [MUAC] >11.5 cm and ≤12.5 cm). Children will be asked to return to the PHU every two weeks for follow-up, where caretakers report on the child's clinical symptoms and use of the food at home, growth measurements are re-assessed, until they reach one of the primary outcomes listed below. A ration of supplementary food sufficient for two weeks (14 days) will be distributed at each visit. Children will be monitored for relapse after discharge and be interviewed for basic IYCF information at graduation, 1-month and 3-month follow up.
The primary outcome measures are graduation from MAM (achieving MUAC ≥ 12.5 cm by 12 weeks) once or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to graduate from MAM by 12 weeks, default).
Additional analysis will consider achievement of WHZ => -2 among children treated for either up to 12 weeks or until reaching graduation based on MUAC. Secondary outcome measures include rates of weight, height, and MUAC gain, change in WHZ, LAZ, and HAZ , WHZ ≥ -2, time to graduation, and any possible adverse effects from the supplementary foods.
Cost effectiveness will assess differences among the four study arms in cost per case of MAM graduated.
The field research team will randomly select a subsample of caregivers of enrolled children for in-depth interviews and in-home observations, which will take place in the participants' home. In addition, the field research team will conduct focus group discussions with a smaller subsample of caregivers, to take place in a central and convenient location. The purpose of the in-home observations is to observe aspects of the family's preparation and consumption of the ration that they would be unlikely to be able to report during focus groups or individual interviews, because respondents may not be conscious of their actions. We will also collect data on behaviors, demographics and other factors contributing to effectiveness, including: ration collection, preparation, consumption, sharing, and selling behaviors, knowledge and communication of social and behavior change communication (SBCC) messages regarding ration use among health workers and beneficiary mothers, other health behaviors such as breastfeeding, dietary diversity and hygiene practices, and demographics such as household food insecurity and number of young children. All interviews, observations, and focus group discussions will be administered by trained research assistants. The team will also conduct interviews with community health volunteers working in the PHUs and the catchment villages they serve.
The research team will implement three sub-studies that aim to:
- Compare the effect of four supplementary foods on changes in body composition of 6-59 month-old children with MAM after four weeks of treatment.
- Examine whether EED modifies the effect of four supplementary foods on 6-59 month-old children with MAM.
- Examine the effects of MAM and 4 supplementary foods on neurocognitive function in 6-24 month-old children.
This study will benefit the food assistance community by providing new research on the cost and cost-effectiveness of supplements to treat MAM, where effectiveness is measured in terms of growth outcomes.
Besides the long term and broader benefits, this work will benefit a large number of young children in the Sierra Leone population. This study will directly benefit Sierra Leone by improving the nutrition of its children and providing education on children's nutrition. The enrolled child will have enough study food provided at home for the recovery from moderate acute malnutrition when consumed along with the regular diet and will be monitored regularly during treatment. This may result in fewer complications (diarrhea, respiratory illnesses) as the child recovers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pujehun, Sierra Leone
- Stacy Griswold, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Super Cereal Plus with amylase
|
Supplementary food for treating MAM
|
ACTIVE_COMPARATOR: Corn-soy Blend Plus and Vegetable Oil
|
Supplementary food for treating MAM
|
ACTIVE_COMPARATOR: Corn-soy Whey Blend and Vegetable Oil
|
Supplementary food for treating MAM
|
ACTIVE_COMPARATOR: Ready-to-Use-Supplementary Food
|
Supplementary food for treating MAM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
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).
|
12 weeks
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight (g/kg/d)
Time Frame: 4 weeks
|
Weight (g/kg/d)
|
4 weeks
|
MUAC (mm/d) gain within first 4 weeks
Time Frame: 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
Time Frame: 6 months
|
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
Time Frame: 12 weeks
|
Time to graduation (for those who graduated)
|
12 weeks
|
Post-treatment growth status
Time Frame: Up to 6 months after graduation/discharge
|
Post-treatment growth status at 1, 3, and 6 months after graduation/discharge.
|
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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Beatrice Rogers, PhD, Tufts University
Publications and helpful links
General Publications
- Griswold SP, Langlois BK, Shen Y, Cliffer IR, Suri DJ, Walton S, Chui K, Rosenberg IH, Koroma AS, Wegner D, Hassan A, Manary MJ, Vosti SA, Webb P, Rogers BL. Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone. Am J Clin Nutr. 2021 Sep 1;114(3):973-985. doi: 10.1093/ajcn/nqab140.
- Suri DJ, Potani I, Singh A, Griswold S, Wong WW, Langlois B, Shen Y, Chui KHK, Rosenberg IH, Webb P, Rogers BL. Body Composition Changes in Children during Treatment for Moderate Acute Malnutrition: Findings from a 4-Arm Cluster-Randomized Trial in Sierra Leone. J Nutr. 2021 Jul 1;151(7):2043-2050. doi: 10.1093/jn/nxab080.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAQR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moderate Acute Malnutrition
-
Action Against Hunger USAUniversity of Washington; Ethiopian Public Health InstituteNot yet recruitingModerate Acute Malnutrition | Severe Acute Malnutrition
-
Microbiome Health Research InstituteUniversity of Cape TownTerminatedModerate Acute Malnutrition | Severe Acute MalnutritionSouth Africa
-
International Centre for Diarrhoeal Disease Research...Suzuhiro Kamaboko Co., Ltd.,JapanCompletedModerate Acute MalnutritionBangladesh
-
International Centre for Diarrhoeal Disease Research...Washington University School of MedicineNot yet recruitingModerate Acute MalnutritionBangladesh
-
International Centre for Diarrhoeal Disease Research...University Ghent; United Nations World Food Programme (WFP); Action Contre la...Not yet recruitingModerate Acute MalnutritionBangladesh
-
PepsiCo Global R&DCompleted
-
Institute of Tropical Medicine, BelgiumUniversity Ghent; Institut de Recherche en Sciences de la Sante, Burkina Faso; Ministry of Health, Burkina FasoCompletedModerate Acute MalnutritionBurkina Faso
-
Action Against Hunger USAUniversity of Washington; Ethiopian Public Health InstituteNot yet recruitingModerate Acute Malnutrition
-
Washington University School of MedicineKamuzu University of Health Sciences; Project Peanut Butter; Balchem CorpEnrolling by invitation
-
Helen Keller InternationalUniversity of California, Davis; United Nations World Food Programme (WFP); U... and other collaboratorsCompletedModerate Acute Malnutrition (MAM)Mali
Clinical Trials on Supplementary Food
-
International Centre for Diarrhoeal Disease Research...Washington University School of MedicineNot yet recruitingModerate Acute MalnutritionBangladesh
-
Tuberculosis Research Centre, IndiaLondon School of Hygiene and Tropical Medicine; Queen Mary University of London and other collaboratorsActive, not recruitingTuberculosis | Malnutrition, ChildIndia
-
International Centre for Diarrhoeal Disease Research...Washington University School of MedicineUnknownNutrition | Microbiota | Complementary FoodBangladesh
-
International Centre for Diarrhoeal Disease Research...Washington University School of MedicineRecruiting
-
Aga Khan UniversityUnited Nations World Food Programme (WFP); People's Primary Healthcare Initiative...WithdrawnSevere Acute MalnutritionPakistan
-
Institut de Recherche en Sciences de la Sante,...Bill and Melinda Gates Foundation; Ministry of Health, Burkina FasoNot yet recruitingAcute Malnutrition With no ComplicationsBurkina Faso
-
International Centre for Diarrhoeal Disease Research...CompletedProtein MalnutritionBangladesh
-
University of OxfordTerminatedMalnutrition | InfectionKenya
-
Institut de Recherche pour le DeveloppementUnited Nations World Food Programme (WFP); UNICEF; Sidaction; Global FundCompletedHIV/AIDS | Malnutrition
-
Medecins Sans Frontieres, NetherlandsLondon School of Hygiene and Tropical Medicine; United Nations World Food Programme... and other collaboratorsCompletedModerate Acute MalnutritionSierra Leone