A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment

NCT ID: NCT03780348

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2019-02-28

Brief Summary

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Weight-for-height/length z-score is one of the indicators used to diagnose acute malnutrition. In the existing method, the assessment involves three steps and takes significant time with a wider room for errors. A new tool is developed to address these drawbacks. A preliminary testing done show encouraging results, but a more robust study is needed. This research will b done with the objective of comparing diagnostic efficiency and reliability of the 'new' method against the 'existing' one using a diagnostic randomized clinical trial method.

Detailed Description

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Acute malnutrition is a major underlying and direct cause of child death. Weight-for-height/length z score (WHZ) is one of the indicators used to assess nutritional status of children. In the existing method, the assessment involves three steps; measuring height, measuring weight and deciding WHZ using a reference graphs or tables. The assessment takes significant time and has wider room for errors. Due to these drawbacks, it is not used at community level where regular active finding takes place.

A new tool is developed to address these drawbacks. It reduces the steps to two aiming at reducing errors and saving time and energy. This study will compare efficiency and reliability of WHZ assessments done with the new tool against the existing method using a diagnostic randomized clinical trial.

Trained health workers will do WHZ assessments in under five children mobilized for nutrition screening program. The 'average time' needed and proportions of 'classification errors' will be compared between the new and the existing methods. Assessments done by two anthropometry experts will be used as gold standard.

The study will determine the gains of the new tool and can potentially change the global practice and help early detection of huge number of wasted children that are being missed.

Conditions

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Severe Acute Malnutrition Wasting

Keywords

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Weigh-for-Height/Length Assessment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Children will be assigned for nutrition status assessment to either of the two groups that use the 'new' or the 'existing' assessment method
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The caregivers of the children, the care provider linking the children to either of the groups and the investigator will not know which group each child is joining and which group is using which method.

Study Groups

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New Method

'New' weight-for-height method will be used to assess children assigned to this arm

Group Type EXPERIMENTAL

New Method

Intervention Type DIAGNOSTIC_TEST

A 'new' WHZ tool will be used to assess children.

Existing Method

'Existing' weight-for-height method will be used to assess children assigned to this arm

Group Type ACTIVE_COMPARATOR

Existing Method

Intervention Type DIAGNOSTIC_TEST

'Existing' WHZ tools will be used to assess children

Health Extension Workers

Health Extension workers will do weight-for-height assessment using the new method

Group Type EXPERIMENTAL

New Method

Intervention Type DIAGNOSTIC_TEST

A 'new' WHZ tool will be used to assess children.

Interventions

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New Method

A 'new' WHZ tool will be used to assess children.

Intervention Type DIAGNOSTIC_TEST

Existing Method

'Existing' WHZ tools will be used to assess children

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All children under five years of age living in the study area.

Exclusion Criteria

* Children for whom weigh-for-height assessments can not be done due to physical deformities and disabilities.
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JSI Research & Training Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yared A Fantaye, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

JSI Training and Research Institute, Inc.

Central Contacts

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Yared A Fantaye, MD, MPH

Role: CONTACT

Phone: +251 911944651

Email: [email protected]

References

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Grellety E, Golden MH. Severely malnourished children with a low weight-for-height have a higher mortality than those with a low mid-upper-arm-circumference: I. Empirical data demonstrates Simpson's paradox. Nutr J. 2018 Sep 15;17(1):79. doi: 10.1186/s12937-018-0384-4.

Reference Type BACKGROUND
PMID: 30217205 (View on PubMed)

Grellety E, Golden MH. Severely malnourished children with a low weight-for-height have a higher mortality than those with a low mid-upper-arm-circumference: III. Effect of case-load on malnutrition related mortality- policy implications. Nutr J. 2018 Sep 15;17(1):81. doi: 10.1186/s12937-018-0382-6.

Reference Type BACKGROUND
PMID: 30217201 (View on PubMed)

Laillou A, Prak S, de Groot R, Whitney S, Conkle J, Horton L, Un SO, Dijkhuizen MA, Wieringa FT. Optimal screening of children with acute malnutrition requires a change in current WHO guidelines as MUAC and WHZ identify different patient groups. PLoS One. 2014 Jul 1;9(7):e101159. doi: 10.1371/journal.pone.0101159. eCollection 2014.

Reference Type BACKGROUND
PMID: 24983995 (View on PubMed)

Pelletier D, Haider R, Hajeebhoy N, Mangasaryan N, Mwadime R, Sarkar S. The principles and practices of nutrition advocacy: evidence, experience and the way forward for stunting reduction. Matern Child Nutr. 2013 Sep;9 Suppl 2(Suppl 2):83-100. doi: 10.1111/mcn.12081.

Reference Type BACKGROUND
PMID: 24074320 (View on PubMed)

Other Identifiers

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JSI R&T #18-46

Identifier Type: -

Identifier Source: org_study_id