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

This study has been completed.
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Alliance for International Medical Action
ClinicalTrials.gov Identifier:
NCT01863394
First received: May 7, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Malnutrition
Other: Screening by mothers
Other: Active comparator: Screening by community health workers

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children Aged 6-59 Months in the Mirria District, Niger

Resource links provided by NLM:


Further study details as provided by Alliance for International Medical Action:

Primary Outcome Measures:
  • The coverage of the therapeutic nutritional program in the control and intervention health districts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 4429
Study Start Date: May 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863394

Locations
Niger
Mirriah health district
Mirria, Zinder, Niger
Sponsors and Collaborators
Alliance for International Medical Action
European Commission
Investigators
Principal Investigator: Nikki BLACKWELL, FCICM Alliance for International Medical Action
Study Director: Isabelle Defourney, MBBS Alliance for International Medical Action
  More Information

No publications provided

Responsible Party: Alliance for International Medical Action
ClinicalTrials.gov Identifier: NCT01863394     History of Changes
Other Study ID Numbers: MUAC À L'ÉCHELLE
Study First Received: May 7, 2013
Last Updated: July 14, 2014
Health Authority: Niger: Institutional Review Board

Keywords provided by Alliance for International Medical Action:
Screening
Malnutrition
Community Management of Acute Malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Child Nutrition Disorders

ClinicalTrials.gov processed this record on August 19, 2014