Different Strategies for Preventing Severe Acute Malnutrition in Niger

April 27, 2017 updated by: Epicentre

Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

7836

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maradi
      • Madarounfa, Maradi, Niger
        • Villages

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children 6 to 24 months

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
duration of follow-up (15 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Céline Langendorf, MPH, Epicentre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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