Nutrition, HealthyNCT05552456
Mid Upper Arm Circumference in Evaluation of Nutrition
An observational study of Nutrition, Healthy, run by Aghapy Gamal Zahy Shafik.
Trial summary
Assess validity of MUAC versus international screening questionnaires in evaluation of nutritional status of infants and children attending Assiut university children hospital. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- How many people
- 537 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Oct 2023
- Phase
- Observational
- 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 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Descriptve cross sectional study that will be conducted on 500 infants and children to assess the validity of MUAC versus international screening questionnaires in evaluation of nutritional status of those infants and children.
Who may be able to join
- Children aged from 6 months up to 5 years.
- Both sexes are included
Who cannot join
- 1-Any children with congenital anomalies. 2-Children diagnosd with genetic diseases. 3-Children with chronic illness. 4-Children younger than 6 months or older than 5 years. 5-Any children whose parents refuse participating in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mid Upper Arm Circumference Versus International Screening Questionnaires in Evaluation of Nutritional Status of Children Attending Assiut University Hospital.
Assess validity of MUAC versus international screening questionnaires in evaluation of nutritional status of infants and children attending Assiut university children hospital.
Read the detailed description
Identification of children at risk of malnutrition is essential in treating disease-related malnutrition and optimising the health of all hospitalised patients. Malnutrition is: "the state of nutrition in which a deficiency or excess or imbalance) of energy, protein,and other nutrients causes measurable adverse effects on tissue/body function and clinical outcome"( Elia M et al; 2005)
Mid-upper arm circumference (MUAC) is an alternate nutritional measure that can be used as a possible predictor of weight-for -height irrespective of age. MUAC measurement is a simple, non-invasive, rapid and inexpensive tool for screening malnutrition. Therefore, World Health Organization (WHO) has suggested for evaluation of MUAC for screening at the community level.(Geneva et al; 2020)
Subjective Global Assessment (SGA), a method of nutritional assessment based on clinical judgment, has been widely used to assess the nutritional status for both clinical and research purposes.( Am J Clin Nutr et al; 2007) Because nutritional assessment is difficult, a new technique called Subjective Global Assessment (SGA) was developed. Its ratings have been found to be highly predictive of outcome.4 The procedure is easy to learn and simple to implement. SGA requires no additional laboratory testing or capital outlay. In addition, SGA has been found to correlate strongly with other subjective and objective measures of nutrition( Covinsky KE et al; 2004)
SGA classifies the patient as:
- Well-nourished B. Mildly malnourished or suspected of malnutrition C. Severely malnourished Clinicians place the patient into one of these categories based upon their subjective rating of the patient in two broad areas: 1. Medical History, 2. Physical Examination.
In general, 60% of the clinician's rating of the patient is based on the results of the medical history, and 40% on the physical examination(see SGA evaluation form)( Covinsky KE et al; 2004)
Medical History Section
The first SGA component, the medical history, involves asking questions and evaluating the patient's answers about the following four parameters:
- Weight change
- Dietary intake
- Gastrointestinal symptoms
- Functional impairment The patient is rated as either nourished, mildly, moderately malnourished, or severely malnourished for each of the four parameters.
Physical Examination Section Physical evidence of malnutrition is rated differently. There are four categories to select from: normal nutrition, mild malnutrition, moderate malnutrition, or severe malnutrition.
Physical signs to examine include:
- Loss of subcutaneous fat
- Muscle wasting
- Edema
- Ascites (in hemodialysis patients only) There are several body locations to examine for each parameter(Covinsky KE et al; 2004)
Anthropometric measurments: Anthropometry is the most used tool for nutitional assessment, since it is non-invasive, cheap and it presents quite satisfactory results. In the anthropometric assessment of children's nutritional status, the variables weight, height (or lengh), sex, and age are comined to form anthropometric indices. These are currently expressed as persentiles or z-scores units. The values obtained in the assassed subjects are compared with those produced from a healthy population,which constitute the anthropometric standards (Da Silva et al; 2020)
Screening Tools For Assessment of Malnutrition in Pediatrics(STAMP) : STAMP is nutrition screening tool widely used in children. It considers the present state of medical condition, nutritional intake and history of weight changes. It was published in 2012 after the pilot study among hospitalized children in the UK. It has also been validated in developed and developing countries(Ong SH et al; 2019)
Screening Tool for Risk on Nutritinal Status and Growth (STRONG): STRONG kids developed for hospitalized children. This nutritional risk-screening questionnaire consists of four items: high-risk disease, subjective clinical assessment, nutritional intake and losses, and weight loss or poor weight gain, and each item is allocated a score of 1or 2 points with a maximum total score of 5 points Questions answered unclear were classified as no. A child with a STRONG kids risk score of 0,1-3, or 4-5 has, respectively, a lowm moderate, or high risk of developing malnutrition(Joosten K et al; 2016)
Paediatric Yorkhill Malnutrition Score (The PYMS): form is presented as a simple structured questionnaire, consisting of four questions (steps) which are strong predictors/symptoms of malnutrition. Each of these steps bears a score from 0 to 2 and an overall nutritional risk score (step 5) is calculated based on the sum of the results of steps 1 action plan follows outlined below:
Step 1: Body Mass Index (BMI) STEP 2: Recent Weight Loss STEP 3: Assess Recent Change in Diet/Nutritional Support (for at least the last week) STEP 4: Acute Admission/Condition Effect on Nutrition (at least the next week) STEP 5: Total Nutrition Risk Score and Action Plan( NHS Greater Glasgow and Clyde et al; 2009)
- Conditions
- Nutrition, Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess validity of MUAC versus international screening questionnaires in evaluation of nutritional status of infants and children attending Assiut university children hospital.
Identify value of nutritional screening tools and anthropometric measurements in evaluation of nutritional status of children and to determine which of them has the highest accuracy to be used in daily practice
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 537 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aghapy Gamal Zahy Shafik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aghapy Gamal Zahy Shafik, Assiut University
- Investigators
- Osama Mahmoud Elasheer, Study director, Professor of pediatricsAmir Mohammed Abo-elgheet, Study chair, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552456
- Sponsor's protocol ID
- Mid upper arm circumference
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elia M, Ljungqvist O and Dowsett J (2005) Principal of Clinical Nutrition:Contrasting the Practice of Nutrition in Health and Disease. Oxford, Blackwell Science Ltd
Guideline: Updates on the Management of Severe Acute Malnutrition in Infants and Children. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK190328/
PubMed 24649519Secker DJ, Jeejeebhoy KN. Subjective Global Nutritional Assessment for children. Am J Clin Nutr. 2007 Apr;85(4):1083-9. doi: 10.1093/ajcn/85.4.1083.
PubMed 17413109Covinsky KE, Martin GE, Beyth RJ, Justice AC, Sehgal AR, Landefeld CS. The relationship between clinical assessments of nutritional status and adverse outcomes in older hospitalized medical patients. J Am Geriatr Soc. 1999 May;47(5):532-8. doi: 10.1111/j.1532-5415.1999.tb02566.x.
PubMed 10323645Ferreira HDS. Anthropometric assessment of children's nutritional status: a new approach based on an adaptation of Waterlow's classification. BMC Pediatr. 2020 Feb 11;20(1):65. doi: 10.1186/s12887-020-1940-6.
PubMed 32046666Ong SH, Chee WSS, Lapchmanan LM, Ong SN, Lua ZC, Yeo JX. Validation of the Subjective Global Nutrition Assessment (SGNA) and Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP) to Identify Malnutrition in Hospitalized Malaysian Children. J Trop Pediatr. 2019 Feb 1;65(1):39-45. doi: 10.1093/tropej/fmy009.
PubMed 29514329Joosten K, van der Velde K, Joosten P, Rutten H, Hulst J, Dulfer K. Association between nutritional status and subjective health status in chronically ill children attending special schools. Qual Life Res. 2016 Apr;25(4):969-77. doi: 10.1007/s11136-015-1130-4. Epub 2015 Sep 11.
PubMed 26362418Nutrition Tool Steering Group, Women and children's Directorate, NHS Greater Glasgow and Clyde, 2009.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid Upper Arm Circumference Versus International Screening Questionnaires in Evaluation of Nutritional Status of Children Attending Assiut University Hospital.
- ClinicalTrials.gov ID
- NCT05552456
- Acronym / sponsor ID
- Mid upper arm circumference
- Conditions
- Nutrition, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 537 participants (estimated)
- Lead sponsor
- Aghapy Gamal Zahy ShafikUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 23 Sep 2022 (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.
Assess validity of MUAC versus international screening questionnaires in evaluation of nutritional status of infants and children attending Assiut university children hospital.
Detailed description
Identification of children at risk of malnutrition is essential in treating disease-related malnutrition and optimising the health of all hospitalised patients. Malnutrition is: "the state of nutrition in which a deficiency or excess or imbalance) of energy, protein,and other nutrients causes measurable adverse effects on tissue/body function and clinical outcome"( Elia M et al; 2005)
Mid-upper arm circumference (MUAC) is an alternate nutritional measure that can be used as a possible predictor of weight-for -height irrespective of age. MUAC measurement is a simple, non-invasive, rapid and inexpensive tool for screening malnutrition. Therefore, World Health Organization (WHO) has suggested for evaluation of MUAC for screening at the community level.(Geneva et al; 2020)
Subjective Global Assessment (SGA), a method of nutritional assessment based on clinical judgment, has been widely used to assess the nutritional status for both clinical and research purposes.( Am J Clin Nutr et al; 2007) Because nutritional assessment is difficult, a new technique called Subjective Global Assessment (SGA) was developed. Its ratings have been found to be highly predictive of outcome.4 The procedure is easy to learn and simple to implement. SGA requires no additional laboratory testing or capital outlay. In addition, SGA has been found to correlate strongly with other subjective and objective measures of nutrition( Covinsky KE et al; 2004)
SGA classifies the patient as:
- Well-nourished B. Mildly malnourished or suspected of malnutrition C. Severely malnourished Clinicians place the patient into one of these categories based upon their subjective rating of the patient in two broad areas: 1. Medical History, 2. Physical Examination.
In general, 60% of the clinician's rating of the patient is based on the results of the medical history, and 40% on the physical examination(see SGA evaluation form)( Covinsky KE et al; 2004)
Medical History Section
The first SGA component, the medical history, involves asking questions and evaluating the patient's answers about the following four parameters:
- Weight change
- Dietary intake
- Gastrointestinal symptoms
- Functional impairment The patient is rated as either nourished, mildly, moderately malnourished, or severely malnourished for each of the four parameters.
Physical Examination Section Physical evidence of malnutrition is rated differently. There are four categories to select from: normal nutrition, mild malnutrition, moderate malnutrition, or severe malnutrition.
Physical signs to examine include:
- Loss of subcutaneous fat
- Muscle wasting
- Edema
- Ascites (in hemodialysis patients only) There are several body locations to examine for each parameter(Covinsky KE et al; 2004)
Anthropometric measurments: Anthropometry is the most used tool for nutitional assessment, since it is non-invasive, cheap and it presents quite satisfactory results. In the anthropometric assessment of children's nutritional status, the variables weight, height (or lengh), sex, and age are comined to form anthropometric indices. These are currently expressed as persentiles or z-scores units. The values obtained in the assassed subjects are compared with those produced from a healthy population,which constitute the anthropometric standards (Da Silva et al; 2020)
Screening Tools For Assessment of Malnutrition in Pediatrics(STAMP) : STAMP is nutrition screening tool widely used in children. It considers the present state of medical condition, nutritional intake and history of weight changes. It was published in 2012 after the pilot study among hospitalized children in the UK. It has also been validated in developed and developing countries(Ong SH et al; 2019)
Screening Tool for Risk on Nutritinal Status and Growth (STRONG): STRONG kids developed for hospitalized children. This nutritional risk-screening questionnaire consists of four items: high-risk disease, subjective clinical assessment, nutritional intake and losses, and weight loss or poor weight gain, and each item is allocated a score of 1or 2 points with a maximum total score of 5 points Questions answered unclear were classified as no. A child with a STRONG kids risk score of 0,1-3, or 4-5 has, respectively, a lowm moderate, or high risk of developing malnutrition(Joosten K et al; 2016)
Paediatric Yorkhill Malnutrition Score (The PYMS): form is presented as a simple structured questionnaire, consisting of four questions (steps) which are strong predictors/symptoms of malnutrition. Each of these steps bears a score from 0 to 2 and an overall nutritional risk score (step 5) is calculated based on the sum of the results of steps 1 action plan follows outlined below:
Step 1: Body Mass Index (BMI) STEP 2: Recent Weight Loss STEP 3: Assess Recent Change in Diet/Nutritional Support (for at least the last week) STEP 4: Acute Admission/Condition Effect on Nutrition (at least the next week) STEP 5: Total Nutrition Risk Score and Action Plan( NHS Greater Glasgow and Clyde et al; 2009)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Descriptve cross sectional study that will be conducted on 500 infants and children to assess the validity of MUAC versus international screening questionnaires in evaluation of nutritional status of those infants and children.
Key inclusion criteria (2 listed)
- Children aged from 6 months up to 5 years.
- Both sexes are included
Key exclusion criteria (1 listed)
- 1-Any children with congenital anomalies. 2-Children diagnosd with genetic diseases. 3-Children with chronic illness. 4-Children younger than 6 months or older than 5 years. 5-Any children whose parents refuse participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess validity of MUAC versus international screening questionnaires in evaluation of nutritional status of infants and children attending Assiut university children hospital.
Time frame: One year
Identify value of nutritional screening tools and anthropometric measurements in evaluation of nutritional status of children and to determine which of them has the highest accuracy to be used in daily practice
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- BackgroundElia M, Ljungqvist O and Dowsett J (2005) Principal of Clinical Nutrition:Contrasting the Practice of Nutrition in Health and Disease. Oxford, Blackwell Science Ltd
- Background: PubMed 24649519Guideline: Updates on the Management of Severe Acute Malnutrition in Infants and Children. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK190328/
- Background: PubMed 17413109Secker DJ, Jeejeebhoy KN. Subjective Global Nutritional Assessment for children. Am J Clin Nutr. 2007 Apr;85(4):1083-9. doi: 10.1093/ajcn/85.4.1083.
- Background: PubMed 10323645Covinsky KE, Martin GE, Beyth RJ, Justice AC, Sehgal AR, Landefeld CS. The relationship between clinical assessments of nutritional status and adverse outcomes in older hospitalized medical patients. J Am Geriatr Soc. 1999 May;47(5):532-8. doi: 10.1111/j.1532-5415.1999.tb02566.x.
- Background: PubMed 32046666Ferreira HDS. Anthropometric assessment of children's nutritional status: a new approach based on an adaptation of Waterlow's classification. BMC Pediatr. 2020 Feb 11;20(1):65. doi: 10.1186/s12887-020-1940-6.
- Background: PubMed 29514329Ong SH, Chee WSS, Lapchmanan LM, Ong SN, Lua ZC, Yeo JX. Validation of the Subjective Global Nutrition Assessment (SGNA) and Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP) to Identify Malnutrition in Hospitalized Malaysian Children. J Trop Pediatr. 2019 Feb 1;65(1):39-45. doi: 10.1093/tropej/fmy009.
- Background: PubMed 26362418Joosten K, van der Velde K, Joosten P, Rutten H, Hulst J, Dulfer K. Association between nutritional status and subjective health status in chronically ill children attending special schools. Qual Life Res. 2016 Apr;25(4):969-77. doi: 10.1007/s11136-015-1130-4. Epub 2015 Sep 11.
- BackgroundNutrition Tool Steering Group, Women and children's Directorate, NHS Greater Glasgow and Clyde, 2009.
- Individual participant dataSharing planned: Undecided
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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.
Osama Mahmoud Elasheer study director
Professor of pediatrics
Amir Mohammed Abo-elgheet study chair
Assistant professor
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition, Healthy, run by Aghapy Gamal Zahy Shafik.
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 2 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 23 Sep 2022. 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 Aghapy Gamal (01287584229, aghapyg987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess validity of MUAC versus international screening questionnaires in evaluation of nutritional status of infants and children attending Assiut university children hospital. (time frame: One year). 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 NCT05552456, which also lists 8 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 23 Sep 2022.