Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition (MAM) in Children in Sierra Leone: a Cluster-randomised, Controlled Clinical Effectiveness Trial

Study Overview
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Brief Summary
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The objective of this study is to test and compare the effectiveness and cost-effectiveness of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. Study participants will receive one of four test foods varying in energy and nutrient density as well as amounts provided. Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group) Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g sugar, per day Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day Plumpy'Sup - 500 kcal/d, 92 g/d This will be a prospective, randomised, controlled effectiveness trial. Aims (Impact) To compare the effectiveness of four supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. (Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered from MAM, relative to comparison group, SC+) of implementing the feeding program using each commodity, taking into consideration costs of procurement/production and distribution (Process) To evaluate the determinants of effectiveness including: consumption adherence, preparation compliance, targeting/sharing of supplement, food components and preparation, adverse effects of foods, water contamination, hygiene and health behaviors, SES, food security, perceived barriers Outcomes Recovery from MAM Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once) Percent default/non-response: children who do not recover after 12 weeks Percent relapse: children who become MAM again within 6 months of recovery Mean number of weeks to recovery Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus. Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have different recovery outcomes to those children fed Super Cereal Plus.

Conditions
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Moderate Acute Malnutrition (MAM)

Intervention / Treatment
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* Dietary Supplement: Super Cereal Plus (SC+)
* Dietary Supplement: Super Cereal (SC), fortified oil, sugar
* Dietary Supplement: Plumpy Sup
* Dietary Supplement: Corn Soy Blend 14 (CSB14) and fortified oil


Participation Criteria
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Eligibility Criteria
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Beneficiary Children (Children 6 months to 59 months old) Inclusion Criteria Child diagnosed with MAM 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 or UNICEF) Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 months to 59 months old) Inclusion Criteria Beneficiary Mother/Caretaker whose child is diagnosed with MAM and enrolled to receive a ration from a feeding site Beneficiary Mother/Caretaker has no age restrictions for inclusion (Note: Mothers/caretakers will be asked to participate regardless of age and consented appropriately; it is possible some mothers may be minors) Subject who is voluntarily willing to participate and indicates by signing (or marking with a thumbprint) the consent form. Exclusion Criteria • Beneficiary Mothers/Caretakers who participate in an interview, observation or FGD once for this study will not be eligible again for participation Community Health Volunteers (CHV)/Health Development Committee Members (HDC) Inclusion Criteria Community Health Volunteers & Health Development Committee Members serving within the catchment area for the PHUs Community Health Volunteers that have been present during the study period Subject who is voluntarily willing to participate and indicates by signing the consent form PPB and Clinic Staff Members Inclusion Criteria All staff members from Project Peanut Butter and the PHU who are directly involved in the feeding program Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria Staff members who joined too recently to have experience of the program change (new commodities) Village Elders/Headmen Inclusion Criteria Village elder/headmen in study commune Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria Village elder/headmen whose community is not involved in the feeding program

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Super Cereal Plus (SC+)<br>800 kcal/d, 215 g/d Current protocol for treating MAM is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. In Sierra Leone, their FBF standard is Super Cereal Plus. | Dietary Supplement: Super Cereal Plus (SC+)<br> <br> |
| Experimental: Super Cereal (SC) and oil and sugar<br>200 g SC and 20 g fortified oil and 15 g sugar, per day Fortified blended food (FBF) Fortified Oil with Vitamins A & D | Dietary Supplement: Super Cereal (SC), fortified oil, sugar<br> <br> |
| Experimental: Corn Soy Blend 14 (CSB14) and fortified oil<br>978 kcal/day - 150 g CSB14 and 45 g oil, per day Fortified blended food (FBF) Fortified Oil with Vitamins A & D | Dietary Supplement: Corn Soy Blend 14 (CSB14) and fortified oil<br> <br> |
| Experimental: Plumpy'Sup<br>500 kcal/d, 92 g/d Ready-to-Use Supplementary Food (RUSF) | Dietary Supplement: Plumpy Sup<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery from MAM | Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once) Percent default/non-response: children who do not recover after 12 weeks Percent relapse: children who become MAM again within 6 months of recovery | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Growth rates | Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. At each clinic visit growth will be measured. | 12 weeks | 
| Duration of treatment | Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. Time to achieve MUAC of 12.5 cm will be documented. | 12 weeks | 
| Cost estimates for participation | Average cost of treatment will be measured per participant, this includes intervention costs and any medical costs needed by participants. The study costs no money to participants. | 12 weeks | 
| Default reason | If a child defaults, then the reason will be an outcome measure. Reasons to default include loss to follow-up (the child will be attempted to be contacted 3 times prior to being considered lost), death, or he/she enters into the inpatient clinic. | 12 weeks | 
| Change in recovery status after 12 weeks | Any changes in recovery will be measured at 6 months at follow-up visits | 6 months |