Different Strategies for Preventing Severe Acute Malnutrition in Niger

• ClinicalTrials.gov Identifier: NCT01828814
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Last Update Posted: April 28, 2017
• Sponsor: Epicentre
• Collaborator: United Nations World Food Programme (WFP)
• Information provided by (Responsible Party): Epicentre

Study Description

Brief Summary:

Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.

Condition or disease
Malnutrition

Study Design

• Study Type: Observational
• Actual Enrollment: 7836 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial
• Study Start Date: July 2011
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: October 2012

Groups and Cohorts

Group/Cohort
RUSF (500kcal/day) and cash transfer; Monthly distributions of Ready-to-use Supplementary Food (RUSF) 500kcal per day associated with cash transfer during hunger gap (5 months) then RUSF 500kcal/day for 10 months
Super Cereal Plus (SC+); Monthly distributions of SC+ 800kcal per day during hunger gaps (5 months twice) and SC+ 400kcal per day in-between (5 months)
RUSF; Monthly distributions of Ready-to-use Supplementary Food (RUSF) 500kcal per day during hunger gaps (5 months twice) and RUSF 250kcal per day in-between (5 months)
RUSF (250kcal/day) and cash transfer; Monthly distributions of Ready-to-use Supplementary Food (RUSF) 250kcal per day associated with cash transfer during hunger gap (5 months) then RUSF 250kcal/day for 10 months
SC+ and cash transfer; Monthly distributions of Super Cereal Plus (SC+) 800 kcal per day associated with cash transfer during hunger gap (5 months)
SC+ and household ration; Monthly distributions of Super Cereal Plus (SC+) 800 kcal per day associated with food ration for household support during hunger gap (5 months)
Cash transfer; Monthly distributions of cash transfer only during hunger gap (5 months)

Outcome Measures

Primary Outcome Measures :

1. Incidence of severe acute malnutrition [ Time Frame: 15 months ]

   Severe acute malnutrition was defined as : Weight for Height Z-score (WHO Standards 2006)< -3 and/or mid-upper arm circumference (MUAC) < 115mm and/or bipedal oedema. MUAC was measured at the midpoint of a child's left arm with a plastic measuring tape with a precision of 1 mm.

   These indicators were evaluated monthly during the entire follow-up (15 months).

Secondary Outcome Measures :

1. Mortality [ Time Frame: duration of follow-up (15 months) ]
   Mortality events include all reports for which the cause for absence from surveillance visits was reported to be death by a family member.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 24 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Children 6 to 24 months

Criteria

Inclusion Criteria:

• resident in selected villages
• height between 60 and 80 cm.

Exclusion Criteria:

• refusal to participate

Contacts and Locations

Locations

Niger

Villages

Madarounfa, Maradi, Niger

Sponsors and Collaborators

Epicentre

United Nations World Food Programme (WFP)

Investigators

• Principal Investigator: Céline Langendorf, MPH; Epicentre

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sayyad-Neerkorn J, Langendorf C, Roederer T, Doyon S, Mamaty AA, Woi-Messe L, Manzo ML, Harouna S, de Pee S, Grais RF. Preventive Effects of Long-Term Supplementation with 2 Nutritious Food Supplements in Young Children in Niger. J Nutr. 2015 Nov;145(11):2596-603. doi: 10.3945/jn.115.213157. Epub 2015 Sep 30.

Langendorf C, Roederer T, de Pee S, Brown D, Doyon S, Mamaty AA, Touré LW, Manzo ML, Grais RF. Preventing acute malnutrition among young children in crises: a prospective intervention study in Niger. PLoS Med. 2014 Sep 2;11(9):e1001714. doi: 10.1371/journal.pmed.1001714. eCollection 2014 Sep.

• Responsible Party: Epicentre
• ClinicalTrials.gov Identifier: NCT01828814
• Other Study ID Numbers: Epicentre
• First Posted: April 11, 2013
• Last Update Posted: April 28, 2017
• Last Verified: April 2017

Keywords provided by Epicentre:

pediatrics; Ready-to-use Supplementary Food; corn soy blend; cash transfer; prevention of malnutrition; Niger

Additional relevant MeSH terms:

Malnutrition; Severe Acute Malnutrition; Nutrition Disorders