Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition

Study Overview
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Brief Summary
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The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.

Official Title
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Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad

Conditions
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Child, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food
* Behavioral: Food-for-Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: WH≥80% of median of NCHS reference without bilateral pitting oedema; Age ≥ 6 months and ≤36 months; Member of a household with a dependency ratio >4; Not planning to leave the study zone for the coming 5 months; Exclusion Criteria: Not showing appetite; Age < 6 months or age > 36 months Weight-for-Height Z-score <-2 and/or the presence of bilateral pitting oedema in children 6-36 months; Member of a household with a dependency ration ≤ 4; Clinical complications Presence of chronic illness, cardiac disease, congenital abnormalities, cancer; Being allergic to one of the ingredients of the RUF.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Food-for-Training component<br>Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children. | Behavioral: Food-for-Training<br>* Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.<br>|
| Experimental: Food-for-Training + RUF (Plumpy Doz(r))<br>Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children. In addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided. | Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food<br>* 47g Plumpy Doz(r) per day per child<br>Behavioral: Food-for-Training<br>* Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative wasting incidence, hemoglobin concentration |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain |  | monthly | 
| time to become wasted |  | monthly | 
| default rate |  | monthly | 
| RUF acceptability |  | monthly | 
| dietary intake |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moderate acute malnutrition, prevention, Lipid-based supplement