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CompletedNCT01863394MàLÉUpdated Jul 15, 2014

Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children 6-59 Months in Mirria District, Niger

An interventional study of Screening by mothers and Active comparator: Screening by community health workers in Malnutrition, sponsored by Alliance for International Medical Action. Completed at 1 site in Niger. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2014-07-15.

Sponsored by Alliance for International Medical Action · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
4,429
Allocation
Non-randomized
Ages
6 Months to 59 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Malnutrition

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Keywords

  • Screening
  • Malnutrition
  • Community Management of Acute Malnutrition
03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's planned enrollment of 4,429 is above the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Alliance for International Medical Action is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • children whose legal guardian refuses to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,429 participants (estimated)

Study arms

  • Active comparator
    Screening by community health workers

    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

  • Experimental
    Screening by mothers

    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

  • OtherScreening by mothers
  • OtherActive comparator: Screening by community health workers
06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

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

    Nutritional status at admission (mid upper arm circumference +/- oedema) Type of admission to the programme (out-patient or immediate transfer for in-patient care) Source of reference to the programme (Community Health Worker, Mother, other) Date of discharge from the programme Weight at admission to the programme Discharge criteria (cured, died, failed to attend, non-response to treatment, transfer for in-patient nutrition care, transfer to other health care structures) Number of children screened by mothers confirmed to have SAM at the treatment centre Number of children screened by community health workers confirmed to have SAM at the treatment centre

    Time frame: 12 months

07

Study locations

1 site
  • Mirriah health district
    Mirria, Zinder, Niger
08

References and documents

Publications

  • 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. Erratum In: Arch Public Health. 2020 Feb 26;78:17. doi: 10.1186/s13690-020-00401-6. PubMed 27602207 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2013, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2013
First posted
May 29, 2013
Start
May 2013
Primary completionActual
Apr 2014
CompletionActual
Apr 2014
Last update
Jul 15, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01863394
Lead sponsor
Alliance for International Medical Action
Collaborators
European Commission
Responsible party
Sponsor
First posted
May 29, 2013
Start date
May 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Jul 15, 2014

Study contacts

Nikki BLACKWELL, FCICM
principal investigator · Alliance for International Medical Action
Isabelle Defourney, MBBS
study director · Alliance for International Medical Action

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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