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

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

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.

Study Overview

• Status: Completed
• Conditions: Child; Malnutrition
• Intervention / Treatment: Behavioral: Food-for-Training; Dietary supplement: Plumpy Doz(r) - Ready-to-Use Food

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Chad
  • Abéché, Chad
    • Action Contre La Faim Tchad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Food-for-Training component; 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; 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.
Experimental: Food-for-Training + RUF (Plumpy Doz(r)); 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.	Behavioral: Food-for-Training; 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.; Dietary supplement: Plumpy Doz(r) - Ready-to-Use Food; 47g Plumpy Doz(r) per day per child

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative wasting incidence, hemoglobin concentration	monthly

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Action Contre la Faim
• Collaborators: University Ghent
• Investigators: Principal Investigator: Patrick Kolsteren, PhD MD, University Ghent; Principal Investigator: Lieven Huybregts, PhD, University Ghent

Publications and helpful links

General Publications

• Huybregts L, Houngbe F, Salpeteur C, Brown R, Roberfroid D, Ait-Aissa M, Kolsteren P. The effect of adding ready-to-use supplementary food to a general food distribution on child nutritional status and morbidity: a cluster-randomized controlled trial. PLoS Med. 2012;9(9):e1001313. doi: 10.1371/journal.pmed.1001313. Epub 2012 Sep 18.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 10, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: moderate acute malnutrition, prevention, Lipid-based supplement
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: UGENT0410