Severe Acute MalnutritionYared's-toolNCT03780348
A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment
A study testing New Method and Existing Method in people with Severe Acute Malnutrition and Wasting, run by JSI Research & Training Institute, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Severe Acute Malnutrition, Wasting
- What is being tested?
- New Method and Existing Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children under five years of age living in the study area.
Who cannot join
- Children for whom weigh-for-height assessments can not be done due to physical deformities and disabilities.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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
- Severe Acute Malnutrition, Wasting
- Being tested
- New Method, Existing Method
- Keywords
- Weigh-for-Height/Length, Assessment
- Medical subject headings
- Severe Acute Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New MethodDiagnostic test
A 'new' WHZ tool will be used to assess children.
Existing MethodDiagnostic test
'Existing' WHZ tools will be used to assess children
| Study group | Role | What they receive |
|---|---|---|
| New Method | Experimental | 'New' weight-for-height method will be used to assess children assigned to this arm Receives: Diagnostic Test: New Method |
| Existing Method | Active comparator | 'Existing' weight-for-height method will be used to assess children assigned to this arm Receives: Diagnostic Test: Existing Method |
| Health Extension Workers | Experimental | Health Extension workers will do weight-for-height assessment using the new method Receives: Diagnostic Test: New Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Reliability
Proportion of 'assessment errors' between the groups will be compared against that of the gold standard (i.e the assessment done by two experts for each child'
Measured: In 3 months
Efficiency of assessment
The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method
Measured: in 3 months
Reliability of WHZ assessments done by community Health Extension Workers
Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'
Measured: in 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startDec 2018 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children will be assigned for nutrition status assessment to either of the two groups that use the 'new' or the 'existing' assessment method
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JSI Research & Training Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yared A Fantaye, MD, MPH, Principal investigator, JSI Training and Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780348
- Sponsor's protocol ID
- JSI R&T #18-46
- Acronym
- Yared's-tool
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Nutrition assessment data is sensitive for the country and it can only be shared if the regional health bureau allows. It needs time to get their decision
Publications
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.
PubMed 30217205Grellety 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.
PubMed 30217201Laillou 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.
PubMed 24983995Pelletier 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.
PubMed 24074320
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment
- ClinicalTrials.gov ID
- NCT03780348
- Acronym / sponsor ID
- Yared's-tool / JSI R&T #18-46
- Conditions
- Severe Acute Malnutrition, Wasting
- Keywords
- Weigh-for-Height/Length, Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- JSI Research & Training Institute, Inc.University, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Children will be assigned for nutrition status assessment to either of the two groups that use the 'new' or the 'existing' assessment method
| Arm | Type | Receives |
|---|---|---|
| New Method | Experimental | Diagnostic Test: New Method'New' weight-for-height method will be used to assess children assigned to this arm |
| Existing Method | Active comparator | Diagnostic Test: Existing Method'Existing' weight-for-height method will be used to assess children assigned to this arm |
| Health Extension Workers | Experimental | Diagnostic Test: New MethodHealth Extension workers will do weight-for-height assessment using the new method |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children under five years of age living in the study area.
Key exclusion criteria (1 listed)
- Children for whom weigh-for-height assessments can not be done due to physical deformities and disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New MethodA 'new' WHZ tool will be used to assess children. | Diagnostic test | Health Extension Workers, New Method |
| Existing Method'Existing' WHZ tools will be used to assess children | Diagnostic test | Existing Method |
Primary outcome
Diagnostic Reliability
Time frame: In 3 months
Proportion of 'assessment errors' between the groups will be compared against that of the gold standard (i.e the assessment done by two experts for each child'
Efficiency of assessment
Time frame: in 3 months
The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method
Reliability of WHZ assessments done by community Health Extension Workers
Time frame: in 3 months
Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 30217205Grellety 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.
- Background: PubMed 30217201Grellety 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.
- Background: PubMed 24983995Laillou 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.
- Background: PubMed 24074320Pelletier 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.
- Individual participant dataSharing planned: No. Nutrition assessment data is sensitive for the country and it can only be shared if the regional health bureau allows. It needs time to get their decision
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yared A Fantaye, MD, MPH principal investigator
JSI Training and Research Institute, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing New Method and Existing Method in people with Severe Acute Malnutrition and Wasting, run by JSI Research & Training Institute, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yared A Fantaye, MD, MPH (+251 911944651, yared_abebe@et.jsi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Reliability (time frame: In 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780348, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.