NCT01790815

Brief Summary

PRIMARY OBJECTIVE : To determine whether mothers, given minimal group training, are capable of using a MUAC (mid-upper arm circumference) bracelet to screen their children for malnutrition and categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow' (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status) SECONDARY OBJECTIVES : To establish whether there is a difference in the MUAC value if measured on the right arm as opposed to the left, in young children To determine whether there is a difference in the MUAC value if the mid upper arm position is determined visually as opposed to being measured in the 'classical' fashion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

February 12, 2013

Last Update Submit

December 8, 2013

Conditions

Keywords

Acute MalnutritionMid Upper Arm CircumferenceScreening

Outcome Measures

Primary Outcomes (1)

  • inter and intra observer variability

    Variance in result of screening for malnutrition performed by mothers with minimal training compared to 'gold-standard' fully trained health care workers. Screening will be performed with a MUAC (mid-upper arm circumference) bracelet, results will be expressed by category: SAM (severe acute malnutrition), MAM (moderate acute malnutrition) or 'normal nutritional status

    2 years

Secondary Outcomes (2)

  • inter and intra observer variability

    2 years

  • inter and intra observer variability

    2 years

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children present in the inpatient malnutrition treatment unit and paediatric service of the Mirriah district hospital aged between 6-59 months old Children aged between 6-59 months old in the two villages of the Mirriah district, Niger; where the community phase of the study was conducted

You may qualify if:

  • children present in the inpatient malnutrition treatment unit and paediatric service of the Mirriah district hospital aged between 6-59 months old
  • children aged between 6-59 months old in the two villages where the community phase of the study was conducted

You may not qualify if:

  • children receiving treatment in the intensive care unit of Mirriah district hospital
  • children with bilateral oedema
  • children whose mothers or fathers refused consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirriah Health District

Mirriah, Mirriah, Niger

Location

Related Publications (3)

  • Briend A, Maire B, Fontaine O, Garenne M. Mid-upper arm circumference and weight-for-height to identify high-risk malnourished under-five children. Matern Child Nutr. 2012 Jan;8(1):130-3. doi: 10.1111/j.1740-8709.2011.00340.x. Epub 2011 Sep 28.

    PMID: 21951349BACKGROUND
  • Briend A, Garenne M, Maire B, Fontaine O, Dieng K. Nutritional status, age and survival: the muscle mass hypothesis. Eur J Clin Nutr. 1989 Oct;43(10):715-26.

    PMID: 2612460BACKGROUND
  • Blackwell N, Myatt M, Allafort-Duverger T, Balogoun A, Ibrahim A, Briend A. Mothers Understand And Can do it (MUAC): a comparison of mothers and community health workers determining mid-upper arm circumference in 103 children aged from 6 months to 5 years. Arch Public Health. 2015 May 18;73(1):26. doi: 10.1186/s13690-015-0074-z. eCollection 2015.

Related Links

MeSH Terms

Conditions

Protein-Energy MalnutritionKwashiorkorMalnutritionLymphoma, Follicular

Condition Hierarchy (Ancestors)

Protein DeficiencyDeficiency DiseasesNutrition DisordersNutritional and Metabolic DiseasesSevere Acute MalnutritionLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • nikki blackwell, FCICM,FRACP

    Alliance for International Medical Action

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 13, 2013

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations