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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Niger
Study Type
Interventional
Intervention
Screening by mothers
Active comparator: Screening by community health workers
Sponsored by
Alliance for International Medical Action
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malnutrition focused on measuring Screening, Malnutrition, Community Management of Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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:

  • children whose legal guardian refuses to participate in the study

Sites / Locations

  • Mirriah health district

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Screening by community health workers

Screening by mothers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 7, 2013
Last Updated
July 14, 2014
Sponsor
Alliance for International Medical Action
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT01863394
Brief Title
Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children 6-59 Months in Mirria District, Niger
Acronym
MàLÉ
Official Title
Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children Aged 6-59 Months in the Mirria District, Niger
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for International Medical Action
Collaborators
European Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Screening, Malnutrition, Community Management of Acute Malnutrition

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4429 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening by community health workers
Arm Type
Active Comparator
Arm Description
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
Arm Title
Screening by mothers
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Screening by mothers
Intervention Type
Other
Intervention Name(s)
Active comparator: Screening by community health workers
Primary Outcome Measure Information:
Title
The coverage of the therapeutic nutritional program in the control and intervention health districts
Description
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 Outcome Measure Information:
Title
Malnutrition program data for children referred by community health workers & mothers
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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: children whose legal guardian refuses to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikki BLACKWELL, FCICM
Organizational Affiliation
Alliance for International Medical Action
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle Defourney, MBBS
Organizational Affiliation
Alliance for International Medical Action
Official's Role
Study Director
Facility Information:
Facility Name
Mirriah health district
City
Mirria
State/Province
Zinder
Country
Niger

12. IPD Sharing Statement

Citations:
PubMed Identifier
27602207
Citation
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.
Results Reference
derived

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

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