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| ID | Type | Description | Link |
|---|---|---|---|
| USAID | Other Grant/Funding Number | AFP-C-00-09-00016-00 |
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Due to Ebola virus disease outbreak
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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| Project Peanut Butter | OTHER |
| United Nations World Food Programme (WFP) | OTHER |
| United States Agency for International Development (USAID) |
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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.
This will be a prospective, randomised, controlled effectiveness trial.
Aims
Outcomes
Recovery from MAM
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super Cereal Plus (SC+) | Active Comparator | 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. |
|
| Super Cereal (SC) and oil and sugar | Experimental | 200 g SC and 20 g fortified oil and 15 g sugar, per day Fortified blended food (FBF) Fortified Oil with Vitamins A & D |
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| Corn Soy Blend 14 (CSB14) and fortified oil | Experimental | 978 kcal/day - 150 g CSB14 and 45 g oil, per day Fortified blended food (FBF) Fortified Oil with Vitamins A & D |
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| Plumpy'Sup | Experimental | 500 kcal/d, 92 g/d Ready-to-Use Supplementary Food (RUSF) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super Cereal Plus (SC+) | Dietary Supplement |
| ||
| Super Cereal (SC), fortified oil, sugar |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery from MAM |
| 12 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative cost-effectiveness | 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 | 12 weeks |
| Determinants of effectiveness |
Beneficiary Children (Children 6 months to 59 months old)
Inclusion Criteria
Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 months to 59 months old)
Inclusion Criteria
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
PPB and Clinic Staff Members Inclusion Criteria
Village Elders/Headmen Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mark Manary, MD | Washington University School of Medicine | Principal Investigator |
| Beatrice Rogers, PhD | Tufts University, Friedman School of Nutrition | Principal Investigator |
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| Label | URL |
|---|---|
| Food Aid Quality Review | View source |
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| FED |
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| Dietary Supplement |
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| Plumpy Sup | Dietary Supplement |
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| Corn Soy Blend 14 (CSB14) and fortified oil | Dietary Supplement |
|
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 |
To evaluate the determinants of effectiveness including: consumption adherence, preparation compliance, targeting/sharing of supplement, food components and preparation, adverse effects of foods, hygiene and health behaviors, SES, food security, perceived barriers |
| 12 weeks |
| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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