NCT02833740

Brief Summary

The Click-Mid-Upper Arm Circumference study aims to describe and compare the performance of a set of three simplified mid-upper arm circumference classification devices ("Click-MUAC") for use by mothers and caregivers to screen for acute malnutrition in young children. The study will be conducted in Isiolo County, Kenya. The study builds on the recent approach of training mothers to screen for acute malnutrition in their own children (mother MUAC approach). The primary aim of the study is to describe and compare the performance of a set of three prototype Click-MUAC devices against a gold standard of classification, in terms of measures of agreement (sensitivity, specificity, accuracy, Cohen's Kappa, Youden's J) for the classification (diagnosis) of acute malnutrition. A secondary aim of the study is to determine the difference in agreement with the gold standard classification amongst mothers/caregivers using a Click-MUAC prototype versus mothers/caregivers using a regular MUAC tape. The hypothesis of the study is that at least one of the Click-MUAC prototypes is equal to the gold standard of classification in terms of measures of agreement for the classification of acute malnutrition. A secondary hypothesis of the study is that agreement with the gold standard classification is better amongst mothers/caregivers using a Click-MUAC prototype compared to mothers/caregivers using a regular MUAC tape. The outcomes of the study will be used to decide on whether production of a Click-MUAC device is desirable and, if this is the case, to select a design based on the performance of the prototype devices and the stated preferences of intended users.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

May 12, 2016

Last Update Submit

January 27, 2017

Conditions

Malnutrition

Keywords

Mid-Upper Arm Circumference (MUAC)Mother MUACCommunity screening for acute malnutrition

Outcome Measures

Primary Outcomes (1)

  • Youden's J

    Youden's J is a chance-corrected measure of agreement that can be interpreted as the probability of making an informed decision using a given method of ascertaining case-status. The measure is estimated as: J = Sensitivity + Specificity - 1 Sensitivity is defined as the ability of the Click-MUAC device to correctly detect patients who do have the condition (i.e. either severe wasting or moderate wasting or any wasting). The measure is mathematically defined as: sensitivity = a/(a+b) where a= true positive and b= false negative Specificity is defined as the ability of the Click-MUAC device to correctly detect patients who do not have the condition (i.e. either severe wasting or moderate wasting or any wasting). The measure is mathematically defined as specificity= d/(c+d) where d=true negative and c=false positive

    Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to 3 months, for completion as planned for October 2016.

Secondary Outcomes (2)

  • Accuracy

    Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to 3 months, for completion as planned for October 2016.

  • Cohen's Kappa

    Immediate (i.e. this measure can be calculated immediately upon data collection). The measure will be collected throughout study implementation for up to three months, for completion as planned for October 2016.

Study Arms (1)

Click-MUAC & regular MUAC tape screening

OTHER

Each child will have nutritional status classified 11 times: * 3 times with each of the 3 Click-MUAC prototypes by the mother/caregiver * 1 time with a regular MUAC tape by the mother/caregiver * 3 times with each of the 3 Click-MUAC prototypes by the case-finding/programme staff * 1 time with a regular MUAC tape by the case-finding/programme staff * 3 times with a regular MUAC tape by the data collection team ("gold standard")

Device: Click-MUAC prototype & regular MUAC tape

Interventions

Click-MUAC prototype & regular MUAC tapeDEVICE

Screening of children using Click-MUAC and regular MUAC tape

Click-MUAC & regular MUAC tape screening

Eligibility Criteria

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

You may qualify if:

  • Child 6-59 months with MUAC \< 115 mm presenting at health facility for treatment of acute malnutrition or identified at paediatric outpatient clinic.
  • Child 6-59 months with MUAC \< 115 mm currently enrolled in IMAM programme
  • Child 6-59 months with MUAC between 115 mm and 125 mm presenting at health facility for treatment of acute malnutrition or identified at paediatric outpatient clinic.
  • Child 6-59 months with MUAC between 115 mm and 125 mm currently enrolled in IMAM programme.
  • Child 6-59 months with MUAC ≥ 125 mm identified at paediatric outpatient clinic.
  • AND informed consent of mother / caregiver

You may not qualify if:

  • Child \< 6 months or \>59 months.
  • Child with physical handicap preventing mid-upper arm circumference measurement.
  • Child requiring immediate and urgent medical attention for medical complications.
  • Child with mid-upper arm skin lesions (e.g. scabies, impetigo, ringworm).
  • Bilateral pitting oedema.
  • Caregiver consent not given.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isiolo County Health Facilities implementing integrated management of acute malnutrition (IMAM)

Isiolo, Isiolo County, Kenya

RECRUITING

Related Publications (1)

  • Grant A, Njiru J, Okoth E, Awino I, Briend A, Murage S, Abdirahman S, Myatt M. Comparing performance of mothers using simplified mid-upper arm circumference (MUAC) classification devices with an improved MUAC insertion tape in Isiolo County, Kenya. Arch Public Health. 2018 Feb 22;76:11. doi: 10.1186/s13690-018-0260-x. eCollection 2018.

    PMID: 29484177DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Angeline E Folliet-Grant

    Action Against Hunger | ACF-USA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angeline E Folliet-Grant

CONTACT

+41223216280agrant@actionagainsthunger.org

Silke Pietzsch

CONTACT

212-967-7800spietzsch@actionagainsthunger.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

July 14, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)