NCT01863394

Brief Summary

The objective of this study is to determine the efficacity of a community strategy for screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their mothers' compared with a community screening strategy conducted by Community Health Workers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,429

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

May 7, 2013

Last Update Submit

July 14, 2014

Conditions

Keywords

ScreeningMalnutritionCommunity Management of Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

  • The coverage of the therapeutic nutritional program in the control and intervention health districts

    Coverage of the the therapeutic nutritional treatment program is defined as the proportion of children 06-59 months with Severe Acute Malnutrition (Mid Upper Arm Circumference \<115mm and/or oedema) receiving treatment in the program, amongst the total number of children diagnosed with Severe Acute Malnutrition

    12 months

Secondary Outcomes (1)

  • Malnutrition program data for children referred by community health workers & mothers

    12 months

Study Arms (2)

Screening by community health workers

ACTIVE COMPARATOR

One Community Health Worker (CHW) will be trained per village in the comparator arm. The training the CHWs receive will be identical to that delivered in the Community Management of Acute Malnutrition program run by ALIMA/BEFEN (Bien Être de la Femme et l'Enfant Niger) over the last 3 years. This involves 6 hours theoretical training and a practical session in the health centre. CHWs will screen children 06-59 months in their village once a month

Other: Active comparator: Screening by community health workers

Screening by mothers

EXPERIMENTAL

Mothers in the intervention health district will be trained in small womens' groups in their village. Training will have a theoretical component and a practical demonstration component on children in the village During the first baseline door to door mass screening campaign, mothers will also receive individual training on conducting a Mid Upper Arm Circumference (MUAC) classification and looking for pedal oedema. they will receive a brief recap during the three monthly door-to-door mass screening campaigns Mothers will be asked to check their child's MUAC and look for pedal oedema * whenever the child does not seem to be in 'good health' to the mother * whenever the mother feels that the child is 'unwell' or 'sick' * whenever it seems to the mother that her child has lost weight * whenever the mother thinks that it is necessary to do so

Other: Screening by mothers

Interventions

Screening by mothers
Screening by community health workers

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged 06-59 months at the time of the study
  • children who live in a village in the health district participating in the study

You may not qualify if:

  • children whose legal guardian refuses to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirriah health district

Mirriah, Zinder Region, Niger

Location

Related Publications (1)

  • Ale FG, Phelan KP, Issa H, Defourny I, Le Duc G, Harczi G, Issaley K, Sayadi S, Ousmane N, Yahaya I, Myatt M, Briend A, Allafort-Duverger T, Shepherd S, Blackwell N. Mothers screening for malnutrition by mid-upper arm circumference is non-inferior to community health workers: results from a large-scale pragmatic trial in rural Niger. Arch Public Health. 2016 Sep 6;74(1):38. doi: 10.1186/s13690-016-0149-5. eCollection 2016.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nikki BLACKWELL, FCICM

    Alliance for International Medical Action

    PRINCIPAL INVESTIGATOR
  • Isabelle Defourney, MBBS

    Alliance for International Medical Action

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 29, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations